Law 14/1986 of 25 April, General of Health, in Article 40 (5) and (6), confers on the General Administration of the State powers for the regulation, approval, registration or approval, as appropriate, of the medicinal products for human and veterinary use and for other medical devices and articles, and for those which, when affecting the human being, may pose a risk to the health of persons; as well as to regulate and authorise the activities of are engaged in the manufacture and import of these products.

In turn, Article 110 of that law entrusts you to assess the safety, effectiveness and efficiency of health and healthcare technologies.

On the other hand, Law 29/2006 of 26 July on guarantees and the rational use of medicinal products and medical devices includes in its field of application to medical devices, establishing various forecasts in relation to these products that are developed in this royal decree.

Royal Decree 414/1996, of 1 March, which regulates medical devices, has constituted the Spanish regulatory framework for the manufacture, import, certification, placing on the market, putting into service, distribution, advertising and use of medical devices. This regulation incorporated into our domestic law Council Directive 93 /42/EEC of 14 June 1993 on medical devices, which constitutes a specific directive within the meaning of Article 1 (4) of the Directive. 2004 /108/EC of the European Parliament and of the Council of 15 December 2004 on the approximation of the laws of the Member States relating to electromagnetic compatibility.

The aforementioned Royal Decree 414/1996 of 1 March, has been subject to several amendments in order to update it in line with the experience gained during its implementation, as well as to incorporate the new rules resulting from Community provisions.

Directive 2007 /47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90 /385/EEC on the approximation of the laws of the Member States relating to the approximation of the laws of the Member States relating to the approximation of the laws of the Member States Member States on active implantable medical devices, Council Directive 93 /42/EEC on medical devices and Directive 98 /8/EC on the placing of biocidal products on the market, including in a single text all changes to date, thereby facilitating their implementation.

Similarly, certain aspects of other recent Community provisions relevant to the sector, in particular those relating to the obligations of economic operators and border controls, are introduced. Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 laying down the requirements for accreditation and market surveillance relating to the placing on the market of products and repealing Regulation (EC) No 765/2008 Regulation (EEC) No 339/93 and Decision No 768 /2008/EC of the European Parliament and of the Council of 9 July on a common framework for the marketing of products and repealing Council Decision 93 /465/EEC.

The purpose of the legislation on medical devices is to ensure the free movement of health products within the Community, offering, in turn, a high level of protection, in such a way as to ensure that present risks to the health or safety of patients, users or third parties and achieve the performance assigned by the manufacturer, where they are used under the conditions laid down.

To this end, the essential requirements for the products, as well as their accessories, are established, including the computer programs that are involved in their operation. The interpretation and application of such requirements should take into account the state of the art, being aimed at the greatest protection of health and safety.

The essential requirements incorporate all aspects that influence the safety of products, including electromagnetic compatibility and radiation protection, as well as those relating to ergonomic design and level of training of potential users. These include the requirements for particular application to products containing animal tissue derivatives, to which they contain medicinal products as an auxiliary element, and to those incorporating derivatives of human blood. Compliance with requirements is facilitated by reference to harmonised European standards as well as by reference to the corresponding monographs of the European Pharmacopoeia.

Taking into account the potential risks that may arise from their use, medical devices are grouped into four classes: I, IIa, IIb and III, applying the rules of decision based on the vulnerability of the human body. According to these classes, the different conformity assessment procedures are applied, so that in the lower-risk products, class I, the assessment is carried out under the sole responsibility of the manufacturers, while in the rest of the classes is necessary the intervention of a notified body. The degree of intervention and the depth of the assessment are in line with the risk class of the product, although the examination of the technical documentation relating to the design is always necessary for the body to verify the product compliance with the essential requirements.

The notified bodies are designated by the national authorities, who have the capacity to monitor the activities of these bodies, and should provide them with all the necessary information, including the on certificates issued, rejected, suspended or withdrawn. This royal decree details the procedure to be followed by the notified body in its conformity certification activities requested by the manufacturers.

As a general rule, the conformity assessment of products requires clinical data, with clinical research being one of the crucial stages in the development of new products or new applications. details of the conditions under which such investigations should be carried out, their authorisation procedure and the information to be maintained, provided or recorded in the relevant files and databases.

The Health Care System is an essential element, receiving and assessing adverse incidents and transmitting health protection measures aimed at preventing their repetition or reducing their consequences. This royal decree establishes the obligations of manufacturers, users and others responsible for the communication of adverse incidents to such a system, as well as the operation thereof. For the purpose of strengthening health guarantees, the requirement for a card for implantation in certain implants is established to facilitate the adoption of measures on patients, if necessary.

Custom products are a special group of products, since they are intended to be used by a particular patient who has certain characteristics. Therefore, this royal decree establishes specific conditions and procedures to be followed, including the establishment by the manufacturer of a commitment to the communication of adverse incidents and for the monitoring of the products once marketed.

According to the provisions of Article 100 of the General Health Law, manufacturing, grouping and sterilisation of products, as well as their importation, are subject to prior operating licence, the conditions to be met by the undertakings engaged in these activities and the procedure to be followed for the granting of such authorisations.

Taking into account the principles of the new framework for the marketing of the products set out in Community Decision No 768/2008, the obligations of the economic operators involved in the chain of the placing on the market of the products: manufacturers, importers and distributors, in relation to the preservation and maintenance of the relevant documentation at the disposal of the authorities, the adoption of corrective measures against any suspicion or evidence of health risks or lack of conformity of the products, (a) to be subject to the decisions of the health authorities and to cooperation and cooperation with the health authorities, as well as the traceability of the product in the marketing chain. The requirement for the designation of an authorised representative established in the European Union for non-Community manufacturers is also introduced.

This royal decree establishes the conditions for the foreign trade of the products, specifying the requirements to be applied by the sanitary inspection in their import. In turn, the information is determined to provide the health authorities with the products at the time of their making available on Spanish territory, as well as the information concerning the Spanish companies responsible for placing on the market.

On the other hand, distribution and sale are regulated, and in particular the sale of products that require an individualized adaptation. It also regulates the advertising and promotion of products, establishing the conditions under which these activities should be carried out, all in accordance with the provisions laid down in this matter by Law 29/2006 of 26 July, safeguarding the general interest in the protection of public health.

For the same reasons, the sale and advertising of "in vitro" diagnostic medical devices are also regulated, with the requirement of prescription for the sale to the public of certain products, the offered by telematic means is prohibited in application of the principles laid down in Law 29/2006 of 26 July, amending, in this regard, Royal Decree 1662/2000 of 29 September on medical devices for diagnosis "in vitro".

Finally, the powers of inspection and adoption of health protection measures corresponding to the health authorities, as well as the principle of administrative cooperation in relation to other authorities, are determined. National and Community.

This royal decree does not affect the application of Royal Decree 1132/1990 of 14 September 1990 laying down fundamental measures for the radiation protection of persons undergoing medical examinations and treatments; Royal Decree 783/2001 of 6 July 2001 approving the Regulation on the protection of the health protection against ionising radiation; nor of Royal Decree 1836/1999 of 3 December 1999 adopting the Regulation on nuclear installations and (ii) the Commission's proposal for a Council Directive on the protection of the environment and the protection of the environment Regulation on the installation and use of X-ray equipment for medical diagnosis purposes.

On the other hand, and in relation to those products which are intended by its manufacturer to be used both in accordance with the provisions on the personal protective equipment of Royal Decree 1407/1992, 20 of November, under which conditions for the marketing and free movement within the Community of individual protective equipment are regulated, as with the provisions of this royal decree, the essential requirements of security and health of Royal Decree 1407/1992 of 20 November.

By means of this royal decree is repealed Royal Decree 414/1996, of March 1, for which the sanitary products are regulated, and their successive modifications.

This royal decree is adopted under Law 14/1986 of 25 April and Law 29/2006 of 26 July, the third paragraph of which gives the Government the power to determine regulations and conformity with the provisions of this Law the conditions and requirements that will satisfy the sanitary products for their manufacture, import, clinical investigation, distribution, marketing, putting into service, dispensing and use, as well as the the respective administrative procedures, in accordance with the provisions laid down in the European Union.

In accordance with the provisions of Article 149.1.16. of the Constitution, this royal decree is dictated in accordance with the competence of the State to regulate the legislation of pharmaceutical products, the external health, and the bases and general coordination of health, guaranteeing, as regards the processing of personal data, the respect of the Organic Law 15/1999, of 13 December, of Protection of Personal Data, and its rules of development.

In the process of drawing up this standard, the autonomous communities have been consulted and the sectors affected have been heard.

In its virtue, on the proposal of the Minister of Health and Social Policy, with the prior approval of the First Vice President of the Government and Minister of the Presidency, in agreement with the State Council, and after deliberation of the Council of Ministers, at its meeting on 16 October 2009,

DISPONGO:

CHAPTER I

General provisions

Article 1. Object.

This royal decree aims to regulate sanitary products and their accessories, and in particular:

(a) The health guarantees of the products and the essential requirements that they must meet.

b) Procedures for the granting of prior operating licenses for installations.

(c) The requirements for the conformity assessment of medical devices and for the affixing of the CE marking.

(d) The requirements for placing on the market and in service of medical devices with a special purpose.

e) The requirements and actions of notified bodies.

f) Marketing and putting into service of medical devices.

g) The intra-and external trade of medical devices.

h) Clinical investigations with medical devices.

i) The health product surveillance system.

j) Inspection and health protection measures.

k) Advertising and exhibitions.

Article 2. Definitions.

1. For the purposes of this royal decree,

following definitions shall apply:

(a) "Health product" means any instrument, device, equipment, software, material or other article, used alone or in combination, including software intended by its manufacturer for purposes specific diagnosis and/or therapy and which are involved in their proper functioning, intended by the manufacturer to be used in human beings for the purpose of:

1. Diagnosis, prevention, control, treatment, or relief of a disease,

2. º diagnosis, control, treatment, relief, or compensation for an injury or deficiency,

3. research, replacement or modification of the anatomy or a physiological process,

4. Regulation of conception,

and do not exercise the main action that you want to obtain inside or on the surface of the human body by pharmacological, immunological or metabolic means, but whose role such media can contribute.

(b) "Accessories" means an article which, without being a medical device, is specifically intended by the manufacturer to be used in conjunction with a product so that the product can be used in accordance with the purpose intended for the product by its manufacturer.

(c) "In vitro diagnostic medical device" means any sanitary product consisting of a reagent, reactive product, gauge, control material, instrument and material case, instrument, apparatus, equipment or system, used alone or in association with others, intended by the manufacturer to be used in vitro for the study of samples from the human body, including blood and tissue donations, only or mainly for the purpose of to provide information regarding a physiological or pathological state, or a failure congenital, or to determine safety and compatibility with potential receptors, or to monitor therapeutic measures.

Samples for samples shall be considered as "in vitro" diagnostic medical devices. 'Sample containers' means products, whether in them the vacuum has been made or not, specifically intended by the manufacturer for direct containment and for the preservation of samples from the human body for a "in vitro" diagnostic test.

In vitro diagnostic medical devices shall not be considered to be in laboratory general use, except where, due to their characteristics, they are specifically intended by the manufacturer to be used in examinations. "in vitro" diagnostics.

(d) "bespoke product" means a health product manufactured specifically in accordance with the written prescription of a specialist practitioner, in which the latter has the specific design characteristics under its responsibility; is only intended for a particular patient.

Products manufactured according to continuous or serial manufacturing methods that require an adaptation to meet specific needs of the physician or other professional user will not be considered tailor-made products.

(e) "Product for clinical research" means any product intended to be made available to an optional specialist to carry out the research referred to in Annex X, paragraph 2.1, in a suitable human clinical environment.

(f) "Manufacturer" means the natural or legal person responsible for the design, manufacture, conditioning and labelling of a medical device with a view to placing on the market of the product in its own name, irrespective of whether such operations are carried out by the same person or by a third party on behalf of that person.

The obligations to which the manufacturers are subject under this royal decree shall also apply to the natural or legal person who places, condition, treats, totally renews and/or labels one or more products prefab and/or assign them a purpose as a product with a view to the placing on the market of the same in their own name. This subparagraph shall not apply to a person who, without being a manufacturer under the first subparagraph, is to assemble or adapt, in accordance with his intended purpose, products already on the market for a particular patient.

(g) "intended purpose" means the use to which the medical device is intended according to the indications provided by the manufacturer on the labelling, the instructions for use and/or the advertising material.

(h) "market place" means the first making available, for consideration or free of charge, of a medical device, not intended for clinical investigations, with a view to its distribution and/or use on the Community market, whether it is a new or fully renovated product.

i) "Puesta en servicio": the phase in which a product, which is ready to be used on the Community market for the first time in accordance with its intended purpose, is made available to the end user.

(j) "authorised representative" means any natural or legal person established in the European Union, expressly designated by the manufacturer, acting in his place and to whom the authorities and bodies in the Union may address European rather than the manufacturer as regards the obligations of the manufacturer according to this royal decree.

k) "Clinical data": information on safety and/or performance arising from the use of a product; clinical data are obtained from:

1. the clinical investigation of the product in question, or

2. º clinical research or other studies mentioned in scientific publications, of a similar product whose equivalence with the product in question can be demonstrated, or

3. published reports or not on other clinical experiences with the product in question, or with a similar product whose equivalence with that product can be demonstrated.

l) "Subcategory of products": set of products with common areas of intended purpose or common technology.

m) "Group of generic products" means a set of products with identical or similar intended purposes or common technology, allowing them to be classified in a generic manner without mentioning their specific characteristics.

n) "Single-use product": a product intended to be used only once in a single patient.

(n) "specialist optional" means a doctor or any other person who, by virtue of his or her professional qualifications, is legally entitled to extend the prescription or to carry out the investigation in question.

or 'Importer' means any natural or legal person established in the European Union who introduces a product from a third country into Community territory.

p) "Distributor" means any natural or legal person in the supply chain other than the manufacturer or importer who markets a product.

q) "Cell": the smallest organized unit of any life form, capable of having an independent existence and reproducing in a suitable environment.

r) "Fabric": an organization of cells, extracellular components, or both.

s) "Derived": a material obtained from an animal tissue by a manufacturing process, such as collagen, gelatin or monoclonal antibodies.

t) "Invitable": everything that does not have the capacity for metabolism or multiplication.

(u) "transmissible agents" means non-classified pathogenic entities, prions and other entities such as bovine spongiform encephalopathy agents and scrapie agents.

v) "Reduction, elimination or withdrawal": a process by which the number of transmissible agents is reduced, eliminated or removed, in order to avoid an infection or a pathogenic reaction.

w) "Inactivation" means a process by which the ability of the communicable agents to cause an infection or a pathogenic reaction is reduced.

x) "Country of origin" means the country in which the animal was born, reared and/or slaughtered.

and) "Starting materials" means raw materials or any other product of animal origin from which, or with the aid of which, the products referred to in Article 5 (3) are drawn up.

z) "Marketing" means any supply, paid or free, for distribution or use on the Community market in the course of a commercial activity.

a ') "Promoter" means the manufacturer, authorised representative or other individual or organisation that assumes responsibility for the initiation and/or implementation of a clinical investigation.

2. The definitions referred to in paragraph 1, from point (q) to (y), shall apply in the field of products incorporating derivatives of animal origin.

Article 3. Scope and exclusions.

1. This royal decree will apply to:

(a) Healthcare products and their accessories. The accessories shall be treated identical to that of the medical devices. Both are hereinafter referred to as 'products'.

(b) The conditions for the use of the products in clinical investigations.

c) Non-corrective contact lenses; apparatus and instruments used in permanent, semi-permanent or skin tattoo makeup using invasive techniques.

These products will not be able to bear the CE marking and must meet the essential requirements that apply to them. Their manufacture, import, distribution and sale shall be subject to surveillance by the competent health authorities and shall comply with the procedures laid down in Articles 9 and 27.

2. The Spanish Agency for Medicinal Products and Health Products shall decide on the application to a product of the definitions referred to in Article 2 (1) (a) to (e) of this royal decree.

When the Spanish Agency for Medicines and Health Products considers that a decision is required as to whether a product or group of products is subject to any of the definitions in Article 2 (1) (a) to (e) shall submit to the European Commission a duly justified request to take the necessary measures.

3. Where a medical device is intended for the administration of a medicinal product, that product shall be governed by this royal decree and the medicinal product must comply with the provisions of Law 29/2006 of 26 July of guarantees and rational use of medicines and medical devices, and provisions that develop it.

However, if a product of this kind is placed on the market in such a way that the product and the medicinal product constitute a single integrated product intended to be used exclusively in such an association and not This product will be governed by the provisions of Royal Decree 1345/2007 of 11 October 2007 regulating the procedure for the authorisation, registration and conditions for the supply of medicinal products for human use industrially. As regards the product characteristics related to their safety and their performance, the corresponding requirements set out in Article 5 and Annex I of this royal decree shall apply.

4. Where a product incorporates, as an integral part, a substance which, if used separately, can be considered as a medicinal product within the meaning of Article 2.1 of Royal Decree 1345/2007 of 11 October 2007 and which it may exercise in the human body an action incidental to that of the product, said product shall be evaluated and authorized in accordance with the provisions of this royal decree.

5. Where a product incorporates, as an integral part, a substance which, if used separately, may be considered as a component of a medicinal product or a medicinal product derived from human blood or human plasma, as defined in Article 2.18 Royal Decree 1345/2007 of 11 October 2007 and which may exercise in the human body an action ancillary to that of the product, hereinafter referred to as 'substances derived from human blood', that product shall be assessed and authorised in accordance with the provisions of this royal decree.

6. Where a product is intended by its manufacturer to be used both in accordance with the provisions on the individual protective equipment of Royal Decree 1407/1992 of 20 November 1992 governing the conditions for the protection of the The marketing and free movement within the Community of the personal protective equipment, as with the provisions of this royal decree, will also be met the essential safety and health requirements of the Royal Decree 1407/1992, 20 of November.

7. The medical devices whose conformity has been determined in accordance with this royal decree do not apply to them Royal Decree 1580/2006, of 22 December, for which the electromagnetic compatibility of the equipment is regulated electrical and electronic.

8. This provision shall not affect the application of Royal Decree 1132/1990 of 14 September 1990 laying down fundamental measures for the radiation protection of persons undergoing medical examinations and treatment; nor of the Royal Decree 783/2001 of 6 July 2001 approving the Regulation on the protection of the health protection against ionising radiation; nor of Royal Decree 1836/1999 of 3 December 2001 on the regulation of nuclear and radioactive installations; and Nor to that of Royal Decree 1085/2009 of 3 July 2009 approving the Regulation on installation and use of X-ray equipment for medical diagnosis purposes.

9. This royal decree will not apply to:

a) Healthcare products for "in vitro" diagnosis.

b) Active implantable healthcare products.

c) Medicines. The decision on whether a given product is regulated by Royal Decree 1345/2007 of 11 October 2007 or by this provision will be taken into account, in particular, in the main mode of action of the product.

d) Cosmetic products.

(e) Human blood, products derived from human blood, plasma or blood cells of human origin and products which, at the time of their placing on the market, contain such blood products human, plasma or blood cells, with the exception of the products referred to in paragraph 5.

(f) The organs, tissues or cells of human origin and products incorporating or derived from human tissues or cells, with the exception of the products referred to in paragraph 5.

g) organs, tissues or cells of animal origin, except in cases where a product has been made from animal tissues which have been transformed into infeasible or with non-viable products derived from tissues animals.

Article 4. Health guarantees for products.

1. Products can only be placed on the market and/or put into service if they meet the requirements laid down in this royal decree when they have been duly supplied, properly installed and maintained and used in accordance with their requirements. intended purpose, not compromising the safety or health of patients, users or, where appropriate, third parties.

2. At the time of their entry into service in Spain the products must include the data and information contained in paragraph 13 of Annex I, at least in Spanish, in order to provide for a certain and objective form of effective information, true and sufficient about its essential characteristics.

3. Products whose labelling or promotional material contains particulars or flags which fail to mislead may not be placed on the market, attribute functions which do not possess or provide expectations of successful success or which, after their indicated or prolonged use, are not no harmful effect will appear. It shall also not attribute superfluous character to medical or surgical intervention.

4. Only products that comply with the provisions of this royal decree and by qualified and duly trained professionals may be used in Spain, depending on the product concerned. The products must be used under the conditions and according to the purposes laid down by the manufacturer.

Products must be properly maintained in such a way as to ensure that, during their period of use, they retain the safety and performance provided by their manufacturer.

5. In accordance with the provisions of Law 41/2002 of 14 November, basic regulation of patient autonomy and rights and obligations regarding information and clinical documentation, it will be provided to the patient and will be included in his/her history. The information on any implantable medical device that you receive in the course of your treatment. This shall be without prejudice to the provisions of Article 33 concerning the requirement for implantation cards in certain types of implants.

Article 5. Essential requirements.

1. Products shall comply with the essential requirements set out in Annex I which are applicable to them in the light of their intended purpose.

2. Where there is a risk, products which are machinery in accordance with the provisions of Royal Decree 1644/2008 of 10 October 2008 laying down the rules for the placing on the market and putting into service of machinery must be it shall also comply with the essential health and safety requirements laid down therein, provided that such essential health and safety requirements are more specific than the essential requirements set out in Annex I to this royal decree.

3. Products in the manufacture of which are used animal tissues processed in unviable or unviable products derived from animal tissues of bovine, ovine and caprine species, as well as those derived from deer, elk, minions and cats, shall comply with the detailed specifications concerning the risks of transmission of transmissible spongiform encephalopathies (TSEs) under normal conditions of use to patients or other persons listed in Annex XIII to this Regulation. this royal decree. This shall not apply when the products are not intended to come into contact with the human body or are intended to come into contact only with intact skin.

The collagen, gelatin and tallow of the species referred to in the preceding paragraph, used in the production of the products, shall meet at least the requirements for human consumption.

Article 6. Presumption of conformity with the essential requirements.

1. Where medical devices comply with the relevant national standards, adopted in accordance with harmonised standards which satisfy certain essential requirements, they shall be presumed to comply with the essential requirements in question.

2. For the purposes of the preceding paragraph, national rules and harmonised standards are those whose reference numbers have been published in the Official Journal of the State and in the Official Journal of the European Union, respectively.

3. The monographs of the European Pharmacopoeia relating in particular to surgical sutures and the interaction between medicinal products and materials used as containers of the products shall also be considered for the purposes of the second paragraph. medicines, the references of which have been published in the Official Journal of the European Union.

Article 7. Confidentiality.

1. Without prejudice to the existing provisions on professional secrecy, the health authorities shall ensure that all parties to which the application of this royal decree is concerned maintain the confidentiality of any information obtained in the exercise of its function. This shall not affect the obligations of the competent authorities or the notified bodies in respect of reciprocal information and the dissemination of warnings, or of the reporting obligations of the persons concerned, both before the health authorities and before the courts.

2. The following information shall not be considered confidential:

(a) Information on the registration of persons responsible for placing the products on the market pursuant to Article 24;

(b) information intended for users submitted by the manufacturer, the authorised representative, the importer or the distributor in relation to a measure in accordance with Article 32; or

c) the information collected on certificates issued, modified, completed, suspended or withdrawn.

Article 8. Administrative cooperation.

1. The Spanish Agency for Medicinal Products and Sanitary Products shall cooperate with the competent authorities of the other Member States and with the European Commission, with each other the information necessary for the uniform application of the provisions. applicable to medical devices.

2. The cooperation set out in the previous paragraph may be part of initiatives developed at international level.

3. Similarly, the Spanish Agency for Medicines and Health Products and the Autonomous Communities shall cooperate in the field of their competences.

CHAPTER II

Installations

Article 9. Prior operating license of installations.

1. In accordance with Article 100 of Law 14/1986 of 25 April 1986, General of Health, natural or legal persons engaged in the manufacture, import, grouping or sterilisation of medical devices and the facilities in which they are carried These activities will require a prior operating licence, granted by the Spanish Agency for Medicines and Health Products.

By way of derogation from the above paragraph, the establishments and activities of natural or legal persons engaged in the manufacture of bespoke products shall require a prior operating licence granted by the health authorities of the relevant autonomous community.

2. A single prior operating licence shall be granted which shall cover the facilities and the activities to be carried out on the premises, both own and concerted.

3. For the purposes of obtaining the authorizations referred to in the first subparagraph of paragraph 1, they shall be requested from the Spanish Agency for Medicinal Products and Sanitary Products, which shall examine the documentation submitted and shall notify the decision in the three-month period from the date on which the application and the accompanying documentation have entered its register.

4. The Spanish Agency for Medicines and Health Products will ask the functional areas of health of the Government Delegations to report on the conditions under which the companies will develop the activities related to the paragraph First paragraph 1, ordering the inspection of the necessary facilities for such purposes. The request for such a report shall suspend, for a maximum period of three months, the processing of the procedure as provided for in Article 42.5.c) of Law No 30/1992 of 26 November 1992 on the legal system of public and public administrations. Common Administrative Procedure. The request for such a report and its receipt shall be communicated to the undertaking concerned.

By way of derogation from the preceding paragraph, exceptionally, for reasons of urgency or where the nature of the activities is advisable, the report and the relevant inspection may be carried out by the Spanish Agency for Medicines and Health Products.

5. Where undertakings develop manufacturing, grouping, sterilisation or storage activities in installations established outside the Spanish territory, the reports and inspections referred to in the preceding paragraphs may be replaced by the following: by documentation that conveniently endorses the activities developed.

6. The Spanish Agency for Medicinal Products and Sanitary Products shall proceed to the refusal, suspension or revocation of the operating licences when the documentation provided or the corresponding inspection reports is not guaranteed to be the company has the appropriate facilities, means, procedures and personnel to carry out the respective activities or where the conditions under which the licence was granted are not maintained.

7. The Spanish Agency for Medicines and Health Products and the health authorities of the Autonomous Communities shall keep each other informed of the operating licences granted in accordance with this Article, as well as of its modifications, suspensions, or revocations.

8. The operating licences shall have a period of validity specified in the authorisation document and may be revalidated at the request of the data subject, after verification of compliance with requirements.

Any modification of the conditions under which the operating license was granted must be authorized in advance by the same organ that granted it.

9. The conclusion of the activities by the manufacturers does not absolve them of the ultimate responsibility for any non-compliance with the subcontractors.

Article 10. Requirements for the granting of the prior operating license.

1. The application for a prior operating licence shall be accompanied by the supporting documentation of the following requirements:

a) Availability of an organisational structure capable of ensuring the quality of the products and the execution of the procedures and controls from the organisation.

b) Availability of appropriate facilities, procedures, equipment and personnel according to the activities and products concerned. In the event of concerted activities, undertakings must declare the name and address of the subcontracted persons, describe the activities and means available to them, provide the relevant contracts and the manufacturing and control used. Such concerted activities may only be carried out by entities meeting the requirements laid down for manufacturers, with the exception of the prior operating licence in the case of entities which do not comply with the definition of manufacturer.

(c) Availability of a technical officer, entitled a university, whose qualifications accredit an appropriate qualification on the basis of the products he/she holds, who shall exercise the direct supervision of such activities.

By way of derogation from the preceding paragraph, the performance of the duties of a technician responsible for the supervision of custom-made product manufacturing activities, in the orthopedics and dental prostheses sectors, shall be adjust to the set in the first disposition.

The availability shall be credited through a contract specifying the time dedication of the responsible technician, which shall be sufficient in terms of the type and volume of the business activity.

d) Availability of a documentary file system to store the documentation generated with each product manufactured or imported and maintain a record of all products. The documentary file shall be kept at the disposal of the competent authorities.

The manufacturers file will contain:

1. The documentation relating to the quality system and the specifications of each manufactured product, including labelling and instructions for use.

2. The documentation to enable products to be tracked within the production and control chain, as well as their unambiguous identification.

3. The documentation relating to the experience acquired with the use of the products, including the derivative of the surveillance system, as well as the claims and returns.

4. The documentation to understand the design, manufacture and performance of the product so that its compliance with the essential requirements can be assessed.

5. The Marketing Documentation, which will contain the product identifying data (trade name, model, batch/serial number), date of manufacture, and date of shipment, delivery or delivery.

6. The documentation set out in the Annexes for the conformity assessment procedure applied by the manufacturer.

The documentation referred to in points 2. º and 4. may be included in the subcontracted companies provided that their access to the health authorities is guaranteed.

In the case of importers, the content of the documentary file shall relate to the import and control activities performed and their scope shall enable compliance with the obligations referred to in Article 26.

e) Availability of a contact person for the surveillance system-related actions. This designation may be the responsibility of the company's technical officer.

(f) Availability of a procedure to apply the measures of restriction or monitoring of the use of the appropriate products, as well as those which, where appropriate, determine the competent authorities.

CHAPTER III

Classification and compliance marking

Article 11. Classification.

1. The products are classified in Class I, IIa, IIb and III. The attachment of each product to a given class shall be carried out in accordance with the criteria set out in Annex IX to this royal decree.

2. In the event of a dispute between the manufacturer and the notified body on the basis of the application of the classification criteria, the case shall be referred for decision to the competent authorities of which that body depends. If it is a Spanish notified body, the Spanish Agency for Medicines and Health Products will be present.

3. The Spanish Agency for Medicinal Products and Sanitary Products shall decide on the classification which corresponds to the products by applying the criteria set out in Annex IX.

4. Where the Spanish Agency for Medicinal Products and Sanitary Products considers that the classification rules laid down in Annex IX should be adapted, taking into account technical progress and any other information available to it, Under the surveillance system provided for in Article 32, it may submit to the European Commission a duly justified request to take the necessary measures in order to adapt the classification rules.

5. The Spanish Agency for Medicinal Products and Sanitary Products shall submit to the European Commission a duly justified request to take the necessary measures where it considers that:

(a) the application of the classification rules set out in Annex IX requires a decision in relation to the classification of a particular product or category of products;

(b) a particular product or family of products should be classified, by way of derogation from Annex IX, in another class.

6. Notwithstanding the rules set out in Annex IX to this royal decree, breast implants are classified as medical devices included in class III.

7. Notwithstanding the rules set out in Annex IX to this royal decree, hip, knee and shoulder joint prostheses are classified as medical devices included in Class III.

For these purposes, hip, knee and shoulder joint prostheses will be understood as the set of implantable components of a total joint prosthesis system intended to perform a function similar to the joints. natural, respectively, of the hip, knee, or shoulder. Accessory devices (screws, wedges, plates or instruments) are excluded from this definition.

Article 12. CE conformity marking.

1. Only products bearing the CE marking may be placed on the market and put into service. By way of derogation, the products and those intended for clinical investigations shall not bear CE marking.

The CE marking shall be affixed only by the manufacturer or his authorised representative and may be placed only on products which have demonstrated their conformity with the essential requirements referred to in Article 5 and which have followed the conformity assessment procedures referred to in Article 13.

2. The CE conformity marking, which is reproduced in Annex XII, must be affixed visibly, legibly and indelibly to the product or packaging of the product which ensures sterility, provided that this is possible and appropriate, and in the instructions for use; it shall also be placed on the outer packaging, if any.

3. The CE marking shall be followed by the identification number of the notified body responsible for the implementation of the assessment procedures set out in Annexes II, IV, V or VI, as appropriate.

In the case of products for which the conformity assessment procedure does not require the intervention of a notified body, the CE marking may not be accompanied by any identification number of an organism. notified.

4. It shall be prohibited to place marks or inscriptions which may mislead third parties in relation to the meaning or logo of the CE marking. Any other marking may be affixed to the product, the packaging or the instructions for use accompanying the product, provided that the visibility and legibility of the CE marking is not reduced.

The CE conformity marking may also not be affixed in accordance with the provisions of this royal decree on products which do not comply with the definitions laid down in points (a) and (b) of Article 2 (1)

5. In the case of products to which other regulations apply, relating to other aspects in which the affixing of the CE marking is provided for, this marking may be affixed only if the products also comply with the relevant provisions of the the same.

However, if one or more provisions allow the manufacturer, during a transitional period, to choose which measures to apply, the CE marking shall indicate that the products comply only with the regulations applied by the manufacturer. the manufacturer.

In such a case, the references of those regulations, as published in the Official Journal of the European Union, must appear in the documentation, the leaflets, or the instructions provided by them, accompany these products. Such documents must be accessible without the packaging guaranteeing the sterility of the product being destroyed.

6. Where a product has the CE marking in breach of the provisions of this Article, it shall be deemed to have been the subject of an undue EC marking and shall, for all purposes, be treated as a non-compliant product. The same treatment shall be given to the products in which the CE marking is not required to appear.

Article 13. Conditions for affixing the CE marking.

1. The manufacturer, for the purposes of affixing the CE marking, shall, in accordance with the product class concerned, opt for any of the following conformity assessment procedures:

a) Class III products:

1. º EC declaration of conformity (complete system of quality assurance) referred to in Annex II; or

2. The EC type-examination referred to in Annex III, in combination:

1. th With the EC verification referred to in Annex IV, or

2. The CE declaration of conformity (quality assurance of production) referred to in Annex V.

b) Products of class IIb:

1. º EC declaration of conformity (complete quality assurance system) referred to in Annex II; in this case, paragraph 4 of Annex II shall not apply; or

2. The EC type-examination referred to in Annex III, in combination:

1. th With the EC verification referred to in Annex IV, or

2. The CE declaration of conformity (quality assurance of production) referred to in Annex V, or

3. The CE declaration of conformity (quality assurance of the product) referred to in Annex VI.

c) Class IIa products:

EC declaration of conformity referred to in Annex VII in combination:

1. ° With the EC verification referred to in Annex IV, or,

2. ° With the EC declaration of conformity (quality assurance of production) referred to in Annex V, or

3. ° With the EC declaration of conformity (quality assurance of the product) referred to in Annex VI.

Instead of applying these procedures, the manufacturer may also follow the procedure referred to in paragraph 1 (1) (b)

(d) Class I products: the manufacturer shall follow the procedure referred to in Annex VII and shall, prior to placing on the market, make the necessary EC declaration of conformity.

When the manufacturer or authorised representative is established in Spain, the Spanish Agency for Medicinal Products and Health Products shall assess, where appropriate, the documentation referred to in Annex VII for the purpose of establishing the conformity of the products after they have been placed on the market and/or put into service.

2. The manufacturer of the products referred to in Article 5 (3) shall carry out the risk analysis and risk management strategy provided for in Annex XIII before submitting the application for conformity assessment.

3. The manufacturer may instruct his authorised representative to initiate the procedures referred to in Annexes III, IV, VII and VIII. Both the manufacturer and his authorised representative, in the course of such procedures, are subject to the obligations laid down in the relevant Annexes.

4. Where the Spanish Agency for Medicinal Products and Sanitary Products considers that the conformity of a product or a family of products is to be established, by way of derogation from paragraph 1, by applying only one of the following procedures: determined, chosen from among those referred to in this Article, shall submit a duly substantiated request to the European Commission for the necessary measures to be taken.

Article 14. Systems, assemblies and equipment for medical or surgical procedures and sterilization procedures.

1. Any natural or legal person grouping products bearing the CE marking, in accordance with its purpose and within the limits of use provided for by its manufacturers in order to place them on the market as systems, assemblies or equipment for medical or surgical procedures, you must make a statement certifying that:

a) You have verified the reciprocal compatibility of the products according to the manufacturers ' instructions and have made the grouping by following these instructions,

b) Has packed the system, set or equipment for medical or surgical procedures and provided the corresponding information to the users, incorporating the corresponding instructions from the manufacturers, and that

c) All these activities are subject to appropriate internal control and inspection methods.

2. Where the above conditions are not observed, the system, set or equipment for medical or surgical procedures shall be treated as a product in its own right and shall be subject to the appropriate procedure laid down in Article 13 of this Regulation. decree. In particular, this option shall apply to cases where the system, assembly or equipment for medical or surgical procedures includes products which do not bear the CE marking or where the combination of products chosen is not compatible with the the original intended use.

3. Any natural or legal person who is making systems, assemblies or equipment for medical or surgical procedures referred to in the preceding paragraphs for placing on the market, as well as other products bearing the CE marking and which have intended by their manufacturers to be sterilised before use, shall be subject to one of the procedures laid down in Annexes II and V. The application of the said Annexes and the intervention of the notified body shall be limited to the aspects of the procedure relating to the obtaining of sterility until the opening or deterioration of the protective package of the same. The person shall make a statement stating that the sterilisation has been carried out in accordance with the manufacturer's instructions.

4. The products referred to in paragraphs 1 and 3 shall be accompanied by the information referred to in paragraph 13 of Annex I to this royal decree, including, where appropriate, the information supplied by the manufacturers of the products which have been grouped. In any case these products will not require a new CE marking.

The declaration set out in paragraphs 1 and 3 shall be made available to the competent authorities for a period of five years, from the grouping or sterilisation of the products.

Article 15. Express authorizations.

The Spanish Agency for Medicines and Health Products may authorize expressly and individually in the interests of the protection of health, the placing on the market and the putting into service of products for which it does not have satisfied the conformity assessment procedures referred to in Article 13.

CHAPTER IV

Products with a special purpose

Article 16. Tailor-made products.

1. Products as measured shall not be provided with the CE marking or the communication provided for in Article 22 shall apply to them.

2. They can only be placed on the market and put into service as they are:

(a) Your authorised manufacturer or representative has followed the procedure referred to in Annex VIII and made the necessary declaration of conformity before placing on the market, and

(b) in the case of a product of classes IIa, IIb or III, this is accompanied by the declaration provided for in Annex VIII, which shall be available to the patient, which shall be identified by name, an acronym or a numeric code.

The patient will be informed that they have at their disposal this statement, which will be delivered to him at his or her request.

3. The manufacturer or any person who puts into service in Spain products for a measure must have at the disposal of the competent authorities, for a period of at least 5 years, the relation of the products he has put into service in Spain, together with a copy of the declaration set out in paragraph 2.1 of Annex VIII and the documentation referred to in paragraph 3.1 of that Annex. In the case of implantable products, the period shall be at least 15 years.

4. Manufacturers established in Spain which place products on the market must be registered in the Register of Responsible for the placing on the market regulated in Article 24. This obligation shall be extended to the authorised representative when established in Spain.

Article 17. Products intended for clinical research

1. Products intended for clinical research shall not be provided with the CE marking or the communication provided for in Article 22 shall apply to them.

2. Only products in which the following products may be used in clinical research may be made available to an optional specialist for use in clinical research:

(a) Your authorised manufacturer or representative has followed the procedure referred to in Annex VIII and has established the necessary declaration of conformity, and

(b) the investigation complies with the provisions of Articles 30 and 31.

3. The manufacturer of a product for clinical investigations or his authorised representative shall have at the disposal of the competent authorities, for a period of five years, the declaration referred to in paragraph 2.2 of Annex VIII and the documentation of paragraph 3.2 of that Annex, as well as the report referred to in paragraph 2.3.7 of Annex X. In the case of implantable products, the period shall be at least 15 years.

CHAPTER V

Notified Bodies

Article 18. Notified bodies.

1. The Ministry of Health and Social Policy shall designate the bodies which shall carry out the procedures laid down in Articles 13 and 14 and the specific tasks assigned to each body, and shall notify the European Commission and the other Member States. Such designation will be published in the "Official State Gazette" along with the identification number assigned by the European Commission and the specific tasks.

The Ministry of Health and Social Policy will carry out the necessary actions to check the suitability of the agencies in order to be designated and to verify the maintenance of these skills in the designated bodies.

2. Notified bodies shall comply with the requirements set out in Annex XI. Bodies meeting the criteria laid down in the national rules shall be presumed to comply with those requirements. However, the act of designation is independent of any national certification or accreditation and is not linked by them.

3. Where a body has been designated and it is established that such a body no longer satisfies the requirements laid down in Annex XI, the Ministry of Health and Social Policy shall withdraw the authorisation, subject to the appropriate procedure. (a) administrative, with a hearing of the person concerned, and shall inform the European Commission and the other Member States thereof.

Article 19. Actions of the notified body.

1. The notified body shall verify that the product satisfies the essential requirements referred to in this royal decree and shall carry out the tasks provided for in the conformity assessment procedures chosen by the manufacturers.

The notified body shall issue the certificates corresponding to the conformity assessment procedures, as well as the certifications on the quality systems requested by the product manufacturers. health.

2. The documentation relating to the conformity assessment procedures shall be drawn up at least in Spanish. However, the notified body may accept the submission in another language of scientific or specialised documentation which supports part of the conformity assessment.

The notified body may require any data or information it deems necessary to establish or maintain the certificate of conformity, in the light of the procedure chosen.

3. In the assessment of the conformity of a product, the notified body shall take into account the results available under assessment and verification operations which have taken place, where appropriate, in accordance with the provisions of this royal decree, in an intermediate stage of manufacture.

4. Decisions taken by the notified body in accordance with Annexes II, III, V and VI shall specify their period of validity, which shall not exceed five years, and may be extended for periods of a maximum duration of five years. upon request of the manufacturer and agreement of the notified body.

5. The notified body shall inform the Spanish Agency for Medicinal Products and Health Products of all certificates issued, modified, completed, suspended, withdrawn or refused. It shall inform the other notified bodies of the suspended, withdrawn or refused certificates and, on request, of the licences issued. In addition, upon request, all relevant additional information shall be made available to you.

6. Where a notified body finds that the manufacturer does not comply with or no longer complies with the relevant requirements of this royal decree, or that a certificate has not been issued, it shall suspend, place restrictions or withdraw the certificate. a certificate issued, bearing in mind the principle of proportionality, unless the manufacturer ensures compliance with those requirements by implementing effective corrective measures.

In cases of suspension, subject to restriction or withdrawal of the certificate, or in cases where the intervention of the competent authority may be required, the notified body shall inform the Agency of the facts Spanish Medicines and Sanitary Products moving a copy of the corresponding decision. The Spanish Agency for Medicines and Health Products shall inform the other Member States and the European Commission. The Spanish Agency for Medicines and Health Products shall keep the autonomous communities informed of suspended or withdrawn certificates.

7. Upon request, the notified body shall provide all relevant information and documentation, including the budgetary documents necessary for the Ministry of Health and Social Policy to verify compliance with the requirements of the Annex XI.

Article 20. Action of the notified bodies in relation to the products in which tissues of animal origin are used.

1. In the case of products covered by Article 5 (3), the notified bodies shall proceed in accordance with the provisions of the previous Article, assessing the risk analysis of the manufacturer and its risk management strategy and, in particular:

a) The information provided by the manufacturer.

(b) The justification for the use of tissues or derivatives of animal origin.

c) The results of studies on the elimination or inactivation or results of bibliographic research.

(d) The control by the manufacturer of the origin of the raw materials, the finished products and the subcontractors.

e) The need to check the aspects related to the origin of the materials, including supplies by third parties.

2. During the assessment of risk analysis and risk management in the framework of the conformity assessment procedure, notified bodies shall take into account the TSE suitability certificate issued by the European Directorate of Quality of the medicinal product (hereinafter referred to as 'TSE certificate') for the starting materials, where it exists.

3. Before issuing an EC design examination certificate or EC type-examination certificate, the notified bodies shall pay due attention to any comments made by the Spanish Agency for Medicinal Products and Health Products received at a period of three months from the date on which his opinion was requested.

4. Except in the case of products for which starting materials are used which have the TSE certificate referred to in paragraph 2, the national notified bodies shall, through the Spanish Agency for Medicinal Products and Medical devices, the opinion of the competent authorities of the other Member States on their assessment and the conclusions of the analysis and risk management of the tissues or derivatives intended to be incorporated into the medical device, with fixed to what is established by the manufacturer.

Article 21. Procedure of the notified body.

The notified body, in its actions of conformity assessment and certification of quality systems provided for in this royal decree, will follow the following procedure:

1. The procedure shall be initiated at the request of the manufacturer or his authorised representative in the European Union, as referred to in Article 13. To this end, the notified body shall establish the appropriate forms appropriate for each procedure, as well as the technical and quality documentation to be provided in each case.

2. The notified body and the manufacturer or his authorised representative shall establish by common agreement the time limits for the completion of the procedures, taking into account the technological complexity of the products and industrial processes, the number of and the geographical location of the facilities and the number of products included in the procedure.

The deadline setting will be part of the validation of the request and until it takes effect, the procedure will not be allowed to be processed.

3. If the application or the documentation submitted is not in accordance with the provisions laid down, the notified body shall require the person concerned to remedy the deficiencies within 10 days, indicating that if he does not do so, he shall be given a withdrawal from the your request. This period may be extended to the person concerned if the notified body considers this extension justified. The notified body shall inform the person concerned of the withdrawal of the period without the time being taken.

4. The notified body shall take appropriate action to establish or maintain the requested certificate of conformity. In the course of the procedure, it may be necessary for any data or information to be deemed necessary to decide on such conformity.

5. The notified body may recognise the technical reports on quality products or systems issued by competent authorities, both public and private, which have been previously accredited by the notified body itself, and which are issue in the field and the conditions set out in that accreditation.

6. The request for the data or reports shall suspend the time limits agreed until the notified body is in power. Failure to submit such data or reports, after three months of application, shall be subject to the expiry of the procedure and the file of the proceedings, unless the notified body has, at the reasoned request, authorised it. of the applicant, an extension of that period.

7. The notified body shall inform the applicant of the decision taken, referring the relevant certificates to the applicant or rejecting his request. In the latter case, the notification shall contain the statement of reasons for the decision taken, as well as the arguments against it. Against the decisions taken by the notified body, the person concerned may, within one month, express his disagreement with the body itself, who, after having reviewed the arguments, shall communicate the final decision to the person concerned. The same period.

If the disagreement persists, the person concerned may, within one month, express his disagreement with the holder of the Ministry of Health and Social Policy, who, after examining the appropriate file with a hearing of the person concerned, shall decide within the maximum period of three months. Such a decision may be brought in the case of appeals brought under Articles 116 and 117 of Law No 30/1992 of 26 November 1992.

8. The provisions of the preceding paragraph shall also apply in the case of decisions taken by the notified body in accordance with the provisions of Article 19 (6

.

CHAPTER VI

Marketing and commissioning

Article 22. Marketing and commissioning communication and traceability records.

1. Any natural or legal person making available for the first time, for distribution and/or use on Spanish territory, a product of Class IIa, IIb or III, shall make a communication to the Spanish Agency for Medicinal Products and Products Healthcare, at the time it makes such a provision effective.

2. The Spanish Agency for Medicinal Products and Sanitary Products shall keep an updated register with all the communications referred to in the previous paragraph.

3. In addition, any natural or legal person placing medical devices on the market shall maintain a documented record of the products made available on Spanish territory containing at least the following data:

a) Commercial name of the product.

b) Model.

c) Serial number or batch number.

d) Date of shipment or supply.

e) Customer identification.

Article 23. Content of the communication.

1. The communication will contain the following data:

a) Identification data of the person making the communication.

b) The class to which the product belongs.

c) Trade name of the product in Spain and trade names with which the product is marketed in the European Union, in case they are different from the first.

d) Category, product type, and model/s.

e) Description and intended purpose of the product.

(f) Identification data of the manufacturer and the place of manufacture and of his authorised representative, where appropriate.

(g) The identification number of the notified body or bodies involved in the conformity assessment for the purposes of affixing the CE marking, applied annexes and copies of the EC certificates of conformity.

h) Labelling and instructions for use submitted to the notified body or certified by it.

(i) Labelling and instructions for use with which the product is to be marketed in Spain, in so far as the Spanish version is not included in the information referred to in point (h). In this case, the Spanish version shall be a faithful translation of those submitted to the notified body or certified by it.

j) Date on which it is marketed or put into service in Spain.

k) Identification data of distributors in Spain, if they do not match the person referred to in point (a).

2. Any modification of the data referred to in the previous paragraph shall be communicated in accordance with the procedure laid down in Article 22. Any changes to the certificates, including their suspension or withdrawal, as well as the cessation of marketing, shall also be communicated.

Article 24. Register of Responsible for the placing on the market of medical devices.

1. Any manufacturer established in Spain placing on the market products of Class I, as well as custom products, or carrying out the activities referred to in Article 14, shall communicate to the Spanish Agency for Medicinal Products and Products Health to be included in the Register of Responsible for the placing on the market which maintains the same, where it will consist of the address of its registered office and the description of the products in question. This obligation shall be extended to the authorised representative when established in Spain.

2. Any modification of the data referred to in the previous paragraph shall be communicated in accordance with the procedure laid down in this Article. The cessation of the placing on the market of the products shall also be communicated.

3. The Spanish Agency for Medicinal Products and Sanitary Products shall, upon request, inform the other Member States and the European Commission of the data provided by the manufacturer or authorised representative referred to in this Article.

Article 25. Information to the Autonomous Communities.

The Spanish Agency for Medicines and Health Products shall provide access to the records provided for in Articles 22 and 24, to the competent health authorities of the Autonomous Communities.

Article 26. Obligations of economic operators.

1. Where a manufacturer placing on the market on his own behalf a product, has no registered office in a Member State, he shall designate a single authorised representative in the European Union. This designation shall be kept at the disposal of the competent authorities.

2. The manufacturer or his authorised representative shall keep the declaration of conformity and the documentation provided for in the Annexes which it applies, and the decisions, reports and certificates of the notified bodies, at the disposal of the competent health authorities for the purpose of monitoring for a period of five years from the date of manufacture of the last product. In the case of implantable products this period will be 15 years.

3. Manufacturers, their authorised representatives, importers and distributors shall:

(a) To present in Spanish, in response to a reasoned request from the health authorities, how much information is deemed necessary to judge on the conformity of a product. However, the presentation of documentation supporting such conformity may be accepted in other languages which can be easily understood by those authorities. Refusal to provide the documentation referred to in this Article may be considered as a presumption of non-conformity.

In the event that the importer or distributor does not dispute the documentation referred to in the previous paragraph, they shall be collected from the manufacturer or authorized representative.

(b) End the infringement under the conditions laid down by the health authorities immediately, in the case of a product in which the CE marking does not appear contrary to the provisions of this Directive. decree, or its improper placement, or in the cases of non-compliance.

(c) To satisfy the costs arising from the verification of the non-conformity of a product by the health authorities, where it requires the carrying out of evaluations or tests on the product or its technical documentation. They shall also provide the necessary samples for such verification.

d) Execute any measure of restriction of placing on the market, marketing, or putting into service of the products, as well as their withdrawal from the market, recovery of the users or any measure of monitoring of the use of the appropriate products, as well as those which, where appropriate, may be determined by the health authorities, in the case of suspected or evidence of health risk. They shall cooperate with the authorities in the adoption of such measures.

e) Identify, at the request of the health authorities, any agent who has supplied the product, any agent to whom they have supplied the product, and the health centres to which they have supplied directly the products. These obligations shall be maintained for a period of five years from the date of manufacture or supply of the last product. In the case of implantable products this period shall be fifteen years.

4. Importers, before introducing a product, shall ensure that the product has the CE marking, if appropriate, and that the manufacturer has appointed a representative in the European Union, has carried out the relevant assessment of the product. conformity and has drawn up the required technical documentation. They shall ensure that the product is accompanied by the data and information specified in Article 4 (2), both on the labelling and in the instructions for use, as set out in that Article.

5. Distributors established in Spanish territory, before distributing a product, shall ensure that the product has the CE marking, if appropriate, and that it is accompanied by the data and information specified in Article 4 (2). on the labelling as in the instructions for use, as set out in that Article.

6. In accordance with Article 32, the importer and the distributor shall be satisfied that the notification obligations laid down in the said Article are fulfilled and, if necessary, the notification of the notification. corresponding.

In the event that they receive directly from the health centres the communication of the cases referred to in that article, they must put it to the immediate knowledge of the manufacturer and agree with the details of the notification to the Spanish Agency for Medicines and Health Products.

Article 27. Distribution and sale.

1. Distribution and sales activities:

(a) Only products which comply with this royal decree, and which are not expired, may be distributed and sold only by reference to the date referred to in paragraph (e) above. 13.3 of Annex I.

(b) The distribution and sale of the products shall be carried out in establishments guaranteeing the proper storage and preservation of the products.

(c) Distribution and sales establishments shall be subject to the supervision and inspection of the health authorities of the relevant autonomous community.

(d) The natural or legal persons engaged in such activities shall carry out a prior communication of the commencement of activity to the health authorities of the Autonomous Community, which shall contain:

1. Identification of the distribution or sale establishment.

2. º Types of products that you distribute or sell.

3. The identification and qualification of the responsible technician referred to in paragraph 2.b), where applicable.

The pharmacy offices shall be exempt from such a declaration of activity unless they carry out the activities referred to in paragraph 3, in which case they shall follow the provisions of that paragraph.

e) Sale may be made through vending machines designed for this purpose, provided that the integrity and safety of the product is not impaired, except in cases of products requiring individualized adaptation.

(f) The sale to the public by correspondence and by telematic procedures shall be in accordance with the provisions of Article 2.5 of Law 29/2006 of 26 July.

g) Outpatient sales are prohibited.

2. Distribution establishments:

(a) Distribution establishments shall have the right organisation and means to take any measure that is appropriate in cases of potential risks related to the products. They will have a documented record of the products they distribute, which will contain at least the following data:

1. The product's trade name.

2. Model.

3. º Batch number or serial number.

4. Date of shipment or supply.

5. Customer Identification.

(b) Distribution activities shall be carried out under the supervision of a responsible technician whose qualifications accredit an appropriate qualification, which shall be directly responsible for the performance of the activities and obligations referred to in Article 22, where appropriate. It will also be responsible for maintaining technical-health information on the products it distributes or put into service in Spain.

3. Sales outlets for products requiring individualized adaptation:

(a) establishments which sell to the public products requiring individual adaptation must have the equipment necessary to make such an adaptation and have a professional whose certification is an appropriate qualification for these functions. In the case of orthopaedic products, for the purposes of determining this qualification, the provisions of paragraph 1 of the first provision shall be taken into account.

(b) Before the start of the activity, the establishments shall request and obtain the authorization of the health authority of the autonomous community where they are established, once the health authority has verified that they meet the requirements mentioned in the previous paragraph. For these purposes, they shall provide the necessary data for the establishment, the qualified professional and the appropriate equipment.

CHAPTER VII

Intra and external trade

Article 28. Community circulation and import.

1. Products introduced from Community countries and imported from third countries may only be placed on the market and put into service in Spain if they comply with the requirements laid down in this royal decree.

2. The Spanish Agency for Medicines and Health Products, through the inspection services of the functional areas of health of the Government Delegations, will verify that the imports of sanitary products comply with the following requirements:

(a) That the importer has the operating health license provided for in Article 9 of this royal decree.

(b) The product has the CE marking, except in the case of a product or products intended for clinical investigations.

c) That the product has been subject to the conformity assessment procedures provided for in this royal decree.

In the case of imports of semi-finished products, it shall be verified that they are intended for companies holding the operating licence as manufacturers provided for in Article 9.

3. Where the conditions referred to in the preceding paragraph are not met, the goods shall be rejected.

The product shall also be rejected when the product has an incorrect or false CE marking, where the product has been subject to restriction by the health authorities or when it presents a risk to the health.

4. The functional areas of health shall inform the Spanish Agency of Medicinal Products and Health Products of the rejected import operations.

5. The Spanish Agency for Medicinal Products and Sanitary Products may authorise, for justified reasons, imports of products in which the conditions referred to in paragraph 2 are not met.

Article 29. Export.

Products that are manufactured exclusively for export to non-EU countries and do not meet the requirements set out in this royal decree must be labelled in such a way that they are identified as such. unequivocally, differentiating itself from those destined for the Community market, in order to avoid its use in the Community market.

CHAPTER VIII

Clinical investigations

Article 30. Clinical investigations.

1. The ethical, methodological and protection principles of the test subjects, as referred to in Royal Decree 223/2004 of 6 February, governing the use of medical devices, will be applied in the conduct of clinical research with medical devices. clinical trials with medicinal products, as well as established in Annex X to this royal decree.

Where clinical investigations are carried out with products bearing the CE marking, Article 31 shall not apply to them, unless the purpose of such investigations is to use the products in a an indication different from that referred to in the relevant conformity assessment procedure. The corresponding provisions of Annex X shall continue to apply, with the exception of paragraph 3.

2. Products intended for clinical research may only be made available to medical practitioners if the research has the favourable opinion of the Ethics Committee of Clinical Research accredited by the competent body of the Community. in accordance with the provisions of Article 60 of Law 29/2006 of 26 July. The compliance of the address of the centre where it is to be performed will also be required.

This forecast will be extended to ongoing clinical research modifications that may lead to increased risk to the subjects participating in the trial.

3. The Spanish Agency for Medicines and Health Products will keep up to date a register with all the clinical investigations reported. Such registration shall be made available to the competent health authorities of the Autonomous Communities.

4. The Spanish Agency for Medicines and Health Products will take appropriate measures to ensure public health and order. Where a clinical investigation is refused or suspended, the Spanish Agency for Medicines and Health Products shall communicate its decision and the reasons on which it is based on the European Commission and all Member States.

In the event that the Spanish Agency for Medicines and Health Products requests a significant modification or temporary suspension of a clinical investigation, it shall inform the Member States concerned thereof. actions and the reasons on which the measures taken are based.

5. The sponsor shall inform the Spanish Agency for Medicinal Products and Health Products when the end of the clinical investigation occurs. In the case of early termination, the sponsor shall provide a justification. If the anticipated completion of the clinical investigation is for safety reasons, this notification shall be transmitted to the European Commission and to all Member States. The sponsor shall keep the report referred to in point 2.3.7 of Annex X available to the competent authorities.

6. The Spanish Agency for Medicines and Health Products shall inform the relevant autonomous communities of the decisions taken to ensure the safety of clinical investigations.

Article 31. Procedure for the authorization of clinical investigations.

1. At least 60 days before the beginning of the investigations, the sponsor shall request the authorisation for the Spanish Agency for Medicinal Products and Sanitary Products, accompanying the documentation referred to in paragraph 2.2 of Annex VIII. This request shall be made without prejudice to the communication which, where appropriate, is required by the health authority of the autonomous community concerned.

2. The Spanish Agency for Medicinal Products and Sanitary Products shall verify that the application meets the requirements set out in the preceding paragraph and shall notify the applicant of its admission to the proceedings.

Where the application or the documentation submitted does not meet the requirements set out, the applicant shall be required to remedy the deficiencies within the maximum period of 10 days, with the indication that the applicant does not do so. shall be given as a withdrawal of his request. After the expiry of the period without the cure, the Spanish Agency for Medicines and Health Products will decide, communicating the withdrawal to the person concerned.

3. The Spanish Agency for Medicines and Health Products will evaluate the documentation submitted and will decide to authorize the investigations or to communicate a decision against based on considerations of public health or public order. Investigations may be initiated if, within 60 days of the notification of admission to the application, the Spanish Agency for Medicinal Products and Sanitary Products has not communicated reasoned objections to the applicant, provided that the favourable report of the relevant accredited Clinical Research Ethics Committee on the research programme concerned, including the review of the clinical research plan, as well as the conformity of the management, is provided of the center where the investigation is to be conducted.

4. If further information is required, the applicant shall be requested in writing. The 60-day period shall be suspended at the date of issue of the document and shall be resumed from the date of entry into the Spanish Agency for Medicinal Products and Health Products of the last information requested.

The lack of submission of the requested information after three months of application will produce the expiry of the procedure and the file of the actions, except in that time the Spanish Medicines Agency and Medical devices have authorised, on a reasoned request from the applicant, an extension of that period.

5. By way of derogation from paragraph 3, in the case of products other than those of Class III or implantable or invasive of prolonged use of classes IIa or IIb, clinical investigations may be initiated if one month after the end of the month. notification of admission to the application, the Spanish Agency for Medicinal Products and Sanitary Products would not have communicated reasoned objections to the applicant, provided that the favourable report of the Ethical Committee of Inquiry is available Clinical trial, on the research programme in question, including the review of the clinical research plan, as well as the conformity of the director of the centre in which such investigations are to be carried out.

6. Any modification of a clinical investigation shall be communicated in accordance with the above procedure.

CHAPTER IX

Surveillance System

Article 32. Surveillance system.

1. Manufacturers, or, failing that, authorised representatives, importers or distributors, must send a notification to the Spanish Agency for Medicines and Health Products on the following facts as soon as they are aware of the same, as well as the corrective measures that come:

(a) Any malfunction or alteration of the characteristics or performance of the product, as well as any inadequacy of the labelling or instructions for use which may give rise or may have been place of death or serious deterioration of the health status of a patient or a user.

(b) Any technical or health reason linked to the characteristics or performance of a product which, for the reasons referred to in the preceding subparagraph, has induced the manufacturer to carry out a systematic action on products of the same type.

2. The obligation to notify shall also apply to health professionals and to the authorities which, on the occasion of their activity, were aware of the facts referred to in point (a) of the previous paragraph. The Spanish Agency for Medicinal Products and Health Products shall inform the manufacturer of the product concerned or his authorised representative.

Health centres shall designate a surveillance officer for the procedures resulting from the application of this Article, which shall also monitor compliance with the obligations laid down in Article 33. in relation to the implementation cards. They shall communicate their data to the health authorities of the corresponding autonomous community and to the Spanish Agency for Medicines and Health Products. The health centers belonging to the Health Network of Defense will carry out this communication through the General Inspection of Defense Health, who will transfer it to the Spanish Agency for Medicines and Health Products and to the health authorities of the corresponding autonomous community.

3. The notifications shall be made without prejudice to those which, where appropriate, are required by the health authorities of the autonomous community concerned.

4 The Spanish Agency for Medicinal Products and Sanitary Products shall evaluate and register in a centralised manner the notifications, taking the necessary measures for health protection, as set out in Article 35.

5. The Spanish Agency for Medicinal Products and Health Products shall immediately inform the European Commission and the other Member States of the notification, where possible jointly with the manufacturer or his authorised representative. measures taken or planned to minimise the repetition of reported incidents, including information relating to such incidents.

6. The Spanish Agency for Medicinal Products and Sanitary Products shall give notice to the health authorities of the Autonomous Communities and to the General Inspection of Health of the Defence of Information concerning the measures taken or to be taken adopt in relation to the reported incidents. It shall also give knowledge to other affected agents in cases where appropriate.

7. Any information from a manufacturer, authorised representative, importer or distributor intended to communicate prevention, withdrawal or other corrective actions, as well as any warning related to products placed on the market must be provided in Spanish and must be brought to the attention of the Spanish Agency for Medicines and Health Products before its dissemination. The Spanish Agency for Medicinal Products and Sanitary Products may determine the appropriateness of implementing the proposed measures, preventing or modifying them for justified reasons of public health.

Article 33. Implementation card.

1. The following implants that are distributed in Spain must be accompanied by an implementation card:

a) Heart implants and vascular implants of the central circulatory system.

b) Central nervous system implants.

c) Backbone implants.

d) Hip protein.

e) Knee protein.

f) Breast Prothesis.

g) Intraocular Lents.

2. The implantation card, in triplicate, shall include at least the name and model of the product, the batch number or serial number, the name and address of the manufacturer, the name of the health centre where the implantation was carried out and the date of the same, as well as the identification of the patient (national identity card, passport number), and will be completed by the hospital after implantation.

One of the copies will remain archived in the patient's medical history, another will be provided to the patient and the third will be sent to the supplying company. In the case where a national register of implants has been provided, a copy of the latter copy shall be sent to the national register by the supplying undertaking.

3. The inclusion of the information contained in the card in the medical history or its referral to the supplying undertaking or the National Register of Implants may be carried out by electronic means, provided that the system used has the necessary guarantees for this information to be used for the sole purpose of this article.

4. The Spanish Agency for Medicines and Health Products will have access to the data contained in the cards for the purposes set out in Order SCO/3603/2003, of December 18, for which the National Records of Implants are created.

CHAPTER X

Inspection and health protection measures

Article 34. Inspection.

1. It is up to the health authorities, in the field of their competence, to carry out periodic inspections to verify that the provisions of this royal decree are being complied with.

2. The infringement of the provisions of this royal decree will lead to the adoption by those authorities of the precise corrective measures, irrespective of the penalties they have taken.

3. The Spanish Agency for Medicinal Products and Sanitary Products, by itself or through the inspection services of the health areas of the Government Delegations, shall exercise inspection and control activities in respect of the products of foreign trade and the establishments in which they are manufactured, imported or exported, provided that they are located on national territory, as well as in the other cases provided for in Article 98 (2) of Law 29/2006 of 26 July.

4. The staff at the service of the public administrations who carry out the inspection duties shall proceed as laid down in Article 98 (3) of Law 29/2006 of 26 July and may request any information necessary to provide information. to verify compliance with the provisions of this royal decree for products placed on the market in Spain and for medical research.

5. The authorities of the General Administration of the State and the competent autonomous communities shall assist each other for inspection purposes.

The Spanish Agency for Medicines and Health Products will take appropriate measures to promote cooperation and mutual assistance with the health authorities of the autonomous communities, including the organization of specific control programs.

Article 35. Health protection measures.

1. The Spanish Agency for Medicinal Products and Sanitary Products and other competent health authorities, where they consider that a health product, a tailor-made product or a group of certain products, correctly installed, maintained and used in accordance with their intended purpose, may compromise the health and/or safety of patients, users or third parties, shall take the appropriate precautionary measures provided for in Article 26 of Law 14/1986 of 25 May Article 99 of Law 29/2006 of 26 July.

2. In the event that the measure has been adopted by a health authority other than the Spanish Agency for Medicinal Products and Health Products, the Agency shall immediately inform this body of the measure taken, as well as of the who have motivated her.

3. The Spanish Agency for Medicinal Products and Sanitary Products shall immediately inform the European Commission of the measures taken, indicating the reasons, and in particular whether this decision is due to:

a) Non-compliance with essential requirements.

(b) The incorrect application of the rules or monographs referred to in Article 6, in the event that it is stated that those rules have been applied.

c) A loophole in the above rules.

4. Where a non-conforming product has the CE marking, it has been the subject of a CE improper marking or the CE marking must not appear, contrary to the provisions of this royal decree, the Spanish Agency for Medicines and Health Products and the other competent health authorities shall take appropriate action against the manufacturer, the authorised representative, the importer or the distributor, as appropriate.

In the event that the measure has been adopted by a health authority other than the Spanish Agency for Medicines and Health Products, it will be brought to the attention of this agency. The Spanish Agency for Medicines and Health Products shall communicate to the European Commission and to the other Member States the measures taken when the non-compliance rate may be relevant to other Member States.

5. The Spanish Agency for Medicines and Health Products shall be aware of the measures taken by the appropriate means, and with the appropriate speed to each case, to the health authorities, the health services, the responsible entities or the general public, as appropriate. The cost of such measures shall be borne by the natural or legal person who has given rise to their adoption.

Article 36. Particular health control measures.

When the Spanish Agency for Medicines and Health Products considers, in respect of a particular product or group of products, that, in order to ensure the protection of human health, safety or compliance of public health rules, such products must be withdrawn from the market or that their placing on the market or putting into service must be prohibited, restricted or subject to special conditions, may take all necessary and transitional measures. which are justified, and which will inform the European Commission and the other Member States indicating the reasons for their decision.

For the same reasons, it may lay down provisions on conditions for the use of products or on special monitoring measures and include the necessary warnings to avoid health risks in the use of products.

The measures taken pursuant to this Article shall apply to them as provided for in Article 35 (5).

Article 37. Audience to the stakeholder and resources.

1. Any measure taken in accordance with the two preceding articles must be brought to the attention of the person concerned, unless there are grounds for urgency for adoption.

2. Where, by application of this royal decree, the placing on the market and/or putting into service of a product or the conduct of a clinical investigation is refused or restricted, as well as when a product is withdrawn from the market, or If an import is rejected, the person concerned may express his disagreement to the hierarchical superior body of which the decision has been taken by means of the appeal, in accordance with the provisions of Article 114 et seq. of the Law 30/1992, of 26 November.

CHAPTER XI

Advertising and exhibitions

Article 38. Advertising and promotion of products.

1. The advertising and promotion of the products regulated in this royal decree will be governed by the general principles established in Law 34/1988, of 11 November, General of Advertising, as well as in Articles 27 and 102 of Law 14/1986, of 25 of April, and in Law 29/2006, of July 26.

2. Manufacturers, distributors or marketers, as well as all entities which can maintain direct contact with the patient, may not make direct or indirect publicity directed to the public, in the case of the medical device is funded by the National Health System.

3. The means of information and promotion used as support, whether written, audiovisual or otherwise, shall be of a basic scientific nature and shall be directed and distributed in general to healthcare professionals.

4. The information shall be provided through suitably trained persons who possess sufficient knowledge to provide precise and comprehensive guidance on the products they promote. The content of the information shall include the technical data necessary to enable it to be objectively judged on the usefulness of the medical device.

5. Where, by reason of the nature of the medical device, direct publicity is given to the public, account shall be taken, in particular, of the provisions of Article 78 (5) of Law 29/2006 of 26 July and of the provisions of this Directive. royal decree.

6. Advertising messages that are inserted in any of the general media, including the Internet, as well as any other promotional material addressed to the public, will be subject to prior authorisation by the health authorities of the the autonomous communities. Any other promotional text shall be made available to the health authorities concerned for at least three months after disclosure.

For the purposes indicated in this paragraph, the autonomous community where the company of the announced product has its registered office shall act, unless the advertising is exclusively intended for the territory of an autonomous community, which in this case, the person responsible for the authorisation. Where the undertaking has no registered office in Spain, the autonomous community shall act in which it radiuses the means of dissemination.

7. Advertising or promotion texts shall indicate the conformity of the product with the legislation in force, as well as the contraindications and any possible side effects that may arise from the use of the products.

8. The advertising of products addressed to the public prohibits any mention referring to a health authority or to recommendations made by scientists, health professionals or other persons who may, due to their Reputation, incitement to use. The advertising promoted by public administrations is exempted from this prohibition.

9. It shall be prohibited to carry out advertising directed to the public of products which are directly applied or used by such professionals, as well as the advertising of any product which does not comply with the provisions of this royal decree. carry out any of the purposes referred to in points (a) and (b) of Article 2 (1).

Article 39. Incentives.

In accordance with Article 3 (6) of Law 29/2006 of 26 July, in the framework of the promotion of medical devices it is prohibited to grant, offer or promise premiums, pecuniary advantages or advantages. in kind to the healthcare professionals who prescribe the products, as well as to their relatives or people with whom they live.

The persons listed in the preceding paragraph may not request or accept any of the prohibited incentives.

Article 40. Sponsorship of scientific meetings.

1. The provisions of the foregoing Article shall not constitute an obstacle to the hospitality offered, directly or indirectly, within the framework of exclusively professional and scientific manifestations. Such hospitality must always be moderate at its level and subordinate to the main purpose of the meeting, and it cannot be extended to persons other than health professionals.

2. Prizes, scholarships, contributions and grants to meetings, congresses, study trips and similar events donated by persons related to the manufacture, manufacture, distribution and sale of the products, will be exclusively applied to activities of a scientific nature where the addressees are clinical practitioners or the entities in which they are associated.

In the publications of works and presentations of meetings, congresses and similar events, the funds obtained for their realization and source of financing shall be recorded. The same obligation shall apply to the means of communication by which the public is made public and which obtains funds for or for publication.

Article 41. Exhibitions.

At trade fairs, exhibitions and demonstrations, products that do not comply with the provisions of this royal decree may be presented, provided that in a poster sufficiently visible, placed on or next to the products themselves, clearly indicate that such products cannot be placed on the market or put into service until their conformity is declared. Such demonstrations may never involve the use of such products in patients.

CHAPTER XII

Violations and penalties

Article 42. Violations.

They will have the consideration of violations in accordance with the provisions of this royal decree the actions and omissions provided for in article 35 of Law 14/1986, of 25 April, General of Health, in article 101 of Law 29/2006, of 26 July, on the guarantees and rational use of medicinal products and medical devices, and the following specific ones:

1. Minor infractions:

1. The presentation at fairs, exhibitions and demonstrations of products not suitable for placing on the market or in service without the corresponding indication of their non-conformity or inability to put into service.

2. ª Hinder the inspector's work by any action or omission that disturbs or delays the work.

3. The use by a professional of sanitary products under conditions and for uses other than those indicated by the manufacturer, or by unskilled or duly trained personnel.

4. The non-compliance with the requirements, obligations or prohibitions established in this royal decree that, because of the criteria referred to in this article, merit the rating of mild or not, proceed with its qualification as serious or very serious faults.

2. Serious breaches:

1. The manufacture, grouping and sterilisation of products on national territory without the prior health licence of the installation, as well as the importation of medical devices without the licence prior to establishment.

2. The failure of the duty to have a technical officer with a qualified professional.

3. The use of any other marking that may lead to confusion with the CE marking.

4. The failure to comply with the placing on the market communication duty as well as the modifications of such communications.

5. The failure of the technical officer to comply with the obligations of his or her duties.

6. The lack of maintenance at the disposal of the competent authorities and for the time indicated in the required documentation.

7. Do not carry out the communication set out in Article 24.

8. Distribute and sell sanitary products in establishments that have not been properly communicated.

9. ' Distribute, install, maintain and use medical devices without observing the conditions required, as well as to put on sale altered sanitary products, in poor conditions or when the deadline of validity.

10. The conduct of clinical investigations without complying with the procedures and conditions provided for in this royal decree, except as provided for in the violation 5. of paragraph 3 of this article.

11. To prevent the performance of duly accredited inspectors in the centres where they are manufactured, stored, distributed or sold.

12. The breach of the notification duty provided for in Article 32 of this royal decree.

13. Failure to comply with the requirements relating to the advertising and promotion of medical devices, as well as the conditions laid down.

14. The offer, grant or promise of premiums, pecuniary advantages or benefits in kind to healthcare professionals or any other qualified, related to the use, prescription or dispensing of the products, thus as to their relatives and people of their coexistence. Also requesting or accepting them.

15. The use by a professional of sanitary products under conditions and for uses other than those indicated by the manufacturer, or by personnel who are not qualified or duly trained, with a risk to the health and safety of the people.

16. The putting into service in Spain of sanitary products that do not include the mandatory data at least in Spanish.

17. The misuse of the CE marking on non-conforming products or on the products referred to in Article 12 (4

.

3. Very serious breaches:

1. The placing on the market and/or in service of products that do not meet the essential requirements that apply to them, according to this royal decree.

2. The placing on the market and/or in the service of products which have not satisfied the conformity assessment procedures or which have not made the declarations which, if necessary, result from them being applied.

3. The misuse of the CE marking.

4. Failure to comply with the obligation to implement the measures and actions provided for in Articles 26, 32 and 35 of this royal decree.

5. The carrying out of clinical investigations without complying with the content of the protocols communicated, or without respecting the obligations regarding the consent of the persons subject to them or, where appropriate, their representative, or a substantial breach of the duty of information on the clinical investigation in which you participate as a subject.

6. The incorrect execution, by the notified body, of the actions entrusted to it in Article 19 of this royal decree, as well as to continue to certify once the corresponding designation has been withdrawn.

7. The violation of the principle of confidentiality.

8. The placing on the market and/or putting into service of products that compromise the health or safety of patients, users or, where appropriate, third parties.

9. Inadequate installation and/or maintenance of medical devices, in such a way as to compromise the health or safety of patients, users or, where appropriate, third parties.

Article 43. Penalties.

1. The actions and omissions constituting infringements, as provided for in Article 42 of this royal decree, shall be subject to the appropriate administrative penalties, subject to the appropriate procedure, without prejudice to the civil, criminal or other order responsibilities that may be present. The procedure for imposing sanctions shall be in accordance with the principles laid down in Title IX of the Law on the Legal Regime of Public Administrations and the Common Administrative Procedure.

2. The offences referred to in Article 42 of this royal decree shall be punishable by fine in accordance with the graduation laid down in Article 36 of Law 14/1986 of 25 April, General of Health, and Article 102 of Law 29/2006, of 26 July, on the guarantees and rational use of medicines and medical devices.

3. The closure or closure of establishments or facilities which do not have prior authorisation or mandatory health records, or the suspension of their operation until the defects are remedied, shall not be of a sanction. meet the requirements for health, hygiene or safety reasons.

Additional disposition first. Application of fees.

The procedures laid down in Articles 9, 13, 14, 22 and 30 of this royal decree shall apply to them the corresponding fees set out in Group VIII of Article 1111.1 of Law 29/2006 of 26 July and rational use of medicines and medical devices.

Additional provision second. Sanitary products with components of human origin.

Products incorporating or derived from tissues or cells of human origin referred to in Article 3 (9) (f) shall be governed by:

(a) By Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001 /83/EC and Regulation (EC) No 726/2004, when such tissues or cells are viable.

b) By Royal Decree 1301/2006 of 10 November establishing quality and safety standards for the donation, procurement, evaluation, processing, preservation, storage and distribution of human tissues and cells and the rules for coordination and operation for use in humans are approved where such tissues or cells are not viable.

Additional provision third. Application of this royal decree to the autonomous cities.

The references contained in this royal decree to the autonomous communities, will be understood to be made to the autonomous cities of Ceuta and Melilla, within the framework of their competences.

Additional provision fourth. Application of Chapter VII to in vitro diagnostic medical devices.

Chapter VII of this royal decree "Intra-Community trade" will result in "in vitro" diagnostic medical devices.

Additional provision fifth. Installations of the Armed Forces.

The procedure for applying the provisions of Chapter II of this royal decree at the Armed Forces facilities will be jointly determined between the Spanish Agency for Medicines and Health Products and the General Inspection of Defense Health.

Additional provision sixth. Electronic processing of procedures.

The Spanish Agency for Medicines and Health Products will develop and include in the Department's electronic register procedures to enable applications, declarations and electronic means to be carried out by electronic means. communications provided for in this royal decree and will make available to interested parties standard models and information on the procedures.

First transient disposition. Adaptation of the procedures for conformity assessment of hip, knee and shoulder prostheses.

1. The hip, knee and shoulder prosthesis which have been the subject of the conformity assessment procedure referred to in Article 13.1.b) .1. before 1 September 2007 shall be subject to an assessment of the supplementary conformity in accordance with point 4 of Annex II, which shall give rise to an EC design examination certificate before 1 September 2009. For these purposes, manufacturers shall submit the relevant application and pay the applicable fee.

This provision does not preclude a manufacturer from being able to submit a request for conformity assessment in accordance with the procedure referred to in Article 13.1.a) .2.

2. The hip, knee and shoulder prosthesis which have been the subject of the conformity assessment procedure referred to in Article 13.1.b) .2. 3. before 1 September 2007 may be subject to a procedure for the assessment of the conformity as class III medical devices in accordance with Article 13 (1) (a) (1) (1) (a) or (2), before 1 September 2010. For these purposes, manufacturers shall submit the relevant application and pay the applicable fee.

This provision does not preclude a manufacturer from being able to submit an application for conformity assessment in accordance with the procedure referred to in Article 13.1.a) .1.

Second transient disposition. Validity of the classification and placing on the market of the hip, knee and shoulder prostheses.

1. Until 1 September 2009, the hip, knee and shoulder prosthesis covered by a decision based on the procedure referred to in Article 13.1.b) may be placed on the market and put into service. 2007.

2. Until 1 September 2010, the hip, knee and shoulder prostheses covered by a decision based on the procedure referred to in Article 13.1.b) may be placed on the market .2. ° 3. issued before 1 September 2007. Such prostheses may be put into service after that date.

Transitional provision third. Communication on the placing on the market and putting into service of class IIa health products.

The Spanish Agency for Medicinal Products and Sanitary Products will determine the time limits for making the marketing and commissioning communication for class IIa sanitary products, placed on the Spanish market with prior to the entry into force of this royal decree. This communication shall be exempt from payment of the corresponding fee.

Transitional disposition fourth. Validity of the authorisation, certification and communication procedures.

The procedures for authorisation, certification and communication carried out pursuant to Royal Decree 414/1996 of 1 March, for which health products are regulated, retain their validity.

Single repeal provision. Regulatory repeal.

As many provisions of equal or lower rank are repealed, they oppose the provisions of this royal decree, and in particular Royal Decree 414/1996 of March 1, which regulates sanitary products.

Final disposition first. Responsible technicians in the fields of orthopedics, audioprostheses and dental prostheses.

1. Without prejudice to the provisions of the specific legislation on qualifications, the manufacturing activities of orthopaedic products shall be carried out under the supervision of a responsible technician whose certification is proof of a suitable qualification for these functions, in accordance with the provisions of Article 3 (3) of Royal Decree 437/2002 of 10 May laying down the criteria for the granting of operating licences to manufacturers of tailor-made medical devices.

These activities may also be carried out under the supervision of a professional who has a minimum experience of three years on the date of 14 May 1999, even if he does not have the qualifications referred to in previous.

2. The second subparagraph of the previous paragraph concerning experience shall also apply to sales activities with individual adaptation of orthopaedic and audioprosthetic products in relation to the certification of the professional collection in Article 27 (3) (a).

3. The development of the activities relating to the profession of dental prosthetic shall be in accordance with the provisions of the legislation governing that profession, without prejudice to the fulfilment of the obligations as manufacturers of products. health care.

Final disposition second. Amendments to Royal Decree 1662/2000 of 29 September 2000 on in vitro diagnostic medical devices.

1. Three paragraphs are added to Article 13, with the following wording:

" 6. For the sale to the public of the self-diagnostic products, the corresponding prescription will be required. As an exception, this prescription will not be required in products for the diagnosis of pregnancy and fertility, as well as in the self-diagnostic products for the determination of blood glucose.

7. The sale to the public by correspondence or by telematic procedures of the self-diagnostic products shall be prohibited. However, this modality may be carried out by the pharmacy offices, with the intervention of a pharmacist and the appropriate advice, for products where the corresponding prescription is not necessary.

8. For public health reasons, products for genetic diagnosis shall not be made available to the public. "

2. The following paragraph is added to Article 25 Advertising and presentation of the products:

" 8. It shall be prohibited to carry out advertising aimed at the public of self-diagnostic products, with the exception of those intended for the diagnosis of pregnancy and fertility. It is also prohibited to carry out advertising directed to the public of the products for genetic diagnosis. "

Final disposition third. Competitive titles and basic character.

1. Article 3 (3) of this royal decree has the character of legislation on pharmaceutical products as laid down in Article 149.1.16. of the Constitution.

2. Chapter VII is issued under the exclusive competence of the State to regulate the health of the outside world, in accordance with the provisions of Article 149.1.16. of the Constitution.

3. The rest of the provisions of this royal decree, have the condition of basic norms in the sense provided for in article 149.1.16. of the Constitution, which attributes to the State the competence to establish the bases and the coordination of the health.

Final disposition fourth. Incorporation of European Union law.

This royal decree incorporates into Spanish law Directive 2007 /47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90 /385/EEC on the approximation of the provisions of the Member States on active implantable medical devices, Council Directive 93 /42/EEC on medical devices and Directive 98 /8/EC on the placing of biocidal products on the market.

Final disposition fifth. Faculty of development.

The head of the Ministry of Health and Social Policy is empowered to dictate how many provisions are necessary for the implementation and development of this royal decree, as well as to update the relations of products laid down in Article 33 and in order to adopt the provisions which, in relation to the classification or reclassification of medical devices or the modification or adaptation, where appropriate, of the rules for the classification of such products, are adopted at Community level or are advisable for technical or scientific reasons.

Final disposition sixth. Entry into force.

This royal decree will enter into force on March 21, 2010.

Given in Madrid, 16 October 2009.

JOHN CARLOS R.

The Minister of Health and Social Policy,

TRINIDAD JIMENEZ GARCIA-HERRERA

ANNEX I

Essential Requirements

I. General requirements

1. Products shall be designed and constructed in such a way that their use does not compromise the clinical status or safety of patients, the safety and health of users and, where appropriate, other persons when used under the conditions of use. and for the intended purposes. The potential risks associated with the intended purpose must be acceptable in relation to the benefit they provide to the patient and are compatible with a high level of health and safety protection.

This will involve:

the reduction, as far as possible, of the risk arising from usage errors due to the ergonomic characteristics of the product and the environment in which the product is intended to be used (design that takes into account the patient safety), and

take into account the technical knowledge, experience, training, training and, where appropriate, the medical and physical conditions of the intended users (design for non-professional, professional users, with disability or others).

2. The solutions adopted by the manufacturer in the design and construction of the products shall comply with the principles of security integration taking into account the generally recognised state of the art.

By selecting the most appropriate solutions the manufacturer will apply the following principles, in the order indicated:

Remove or reduce risks as far as possible (inherent design and manufacturing security).

Adopt the appropriate protective measures even alarms, if necessary, in the face of the risks that cannot be eliminated.

Inform users of residual risks due to the incomplete effectiveness of the protection measures taken.

3. The products shall provide the performance attributed to them by the manufacturer and shall be designed, manufactured and conditioned in such a way as to enable them to perform one or more of the functions referred to in points (a) or (b) of paragraph 1 of this Article. Article 2, and as specified by the manufacturer.

4. The characteristics and benefits referred to in paragraphs 1, 2 and 3 shall not be altered to such a degree as to be compromised by the clinical status and safety of patients or, where appropriate, third parties, for the duration of the period of validity. provided by the manufacturer, where the product is subject to situations which may result from the normal conditions of use.

5. Products must be designed, manufactured and conditioned in such a way that their characteristics and performance, according to their intended use, are not altered during storage and transport, taking into account instructions and data provided by the manufacturer.

6. Any unwanted side effects shall constitute an acceptable risk in relation to the benefits attributed.

6 bis. The demonstration of compliance with the essential requirements should include a clinical assessment in accordance with Annex X.

II. Requirements relating to design and manufacturing

7. Chemical, physical and biological properties.

7.1 Products must be designed and manufactured in such a way as to ensure the characteristics and benefits referred to in Part I, "General requirements", with particular attention to:

the choice of the materials used, in particular as regards the toxicity and, where appropriate, the flammability;

the reciprocal compatibility between the materials used and the biological tissues, cells and body fluids, taking into account the intended purpose of the product;

where appropriate, the results of the biophysical investigations, or the modelling whose validity has been previously demonstrated.

7.2 Products must be designed, manufactured and conditioned in such a way as to minimise the risk presented by pollutants and waste to staff involved in transport, storage and use, as well as for patients, according to the intended purpose of the product. Special attention should be given to exposed tissues and the duration and frequency of exposure.

7.3 Products must be designed and manufactured in such a way that they can be safely used with materials, substances and gases with which they come into contact during normal use or in procedures. usual; where the products are intended for the administration of medicinal products, they must be designed and manufactured in a manner compatible with the medicinal products concerned in accordance with the provisions and restrictions governing such products; and their use must be permanently adjusted to the purpose for which they are intended.

7.4 Where a product incorporates, as an integral part, a substance which, if used separately, can be considered as a medicinal product within the meaning of Article 1 of Directive 2001 /83/EC and which it may exercise in the body an action ancillary to that of the product, the quality, safety and usefulness of such a substance shall be verified by analogy with the methods laid down in Directive 2001 /83/EC.

For the substances referred to in the first subparagraph, the notified body, having verified the usefulness of the substance as part of the medical device and taking into account the intended purpose of the product, it must ask one of the competent authorities designated by the Member States or the European Medicines Agency (EMEA), acting in particular, by its committee in accordance with Regulation (EC) No 726/2004, to give a scientific opinion on the quality and safety of the substance, including the clinical benefit-risk ratio of the incorporation of the substance into the product. When issuing their opinion, the competent authority or the EMEA shall take into account the manufacturing process and the data relating to the usefulness of the incorporation of the substance in the product, as established by the notified body.

When the product incorporates, as an integral part, a substance derived from human blood, the notified body, once the utility of the substance is verified as part of the medical device and taking into account the the intended purpose of the product, it should ask the EMEA, acting in particular through its committee, for a scientific opinion on the quality and safety of the substance concerned, including the clinical benefit-risk ratio of the substance derived from human blood in the product. When issuing its opinion, the EMEA shall take into account the manufacturing process and the data relating to the usefulness of the incorporation of the substance in the product, as established by the notified body.

Where an ancillary substance is modified in a product, in particular with regard to its manufacturing process, the notified body of the modifications shall be informed and the competent authority shall consult the competent authority. in the field of medicinal products (i.e. the one which was involved in the initial consultation), in order to confirm the maintenance of the quality and safety of the accessory substance. The competent authority shall take into account the data relating to the usefulness of the incorporation of the substance in the product in accordance with the provisions of the notified body to ensure that the changes do not adversely affect the relationship benefit-risk established with regard to the addition of the substance to the product.

Where the competent authority in the field of medicinal products (i.e. the authority involved in the initial consultation) has information on the ancillary substance which may have an impact on the risk-benefit ratio established for the addition of the substance in the medical device, it shall indicate to the notified body whether or not this information has an effect on the risk-benefit ratio established with regard to the addition of the substance to the medical device. The notified body shall take into account this updated scientific opinion when reviewing its conformity assessment procedure.

7.5 Products must be designed and manufactured in such a way as to minimise the risks arising from substances released by the product. Special attention shall be paid to carcinogenic, mutagenic or toxic substances for reproduction, in accordance with the provisions laid down in Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008, on classification, labelling and packaging of substances and mixtures, and amending and repealing Directives 67 /548/EEC and 1999 /45/EC and amending Regulation (EC) No 1907/2006.

If part of the product (or the product itself) intended to administer and/or remove medicinal products, body fluids or other substances from or to the body, or if the products intended for transport and storage of these products liquid or body substances contain phthalates which are classified as carcinogenic, mutagenic or toxic for reproduction, in categories 1 and 2, in accordance with Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council Council, of 16 December 2008, these products must appear on the labelling of their own the product and/or packaging of each unit or, if applicable, in the sales packages as a product containing phthalate.

If the intended purpose of these products includes the treatment of children or pregnant or lactating women, the manufacturer shall provide a specific justification for the use of these substances as regards the compliance with the essential requirements, in particular those listed in this paragraph, in the technical documentation and, in the instructions for use, information on the residual risks for these patient groups and, if appropriate, on the appropriate precautionary measures.

7.6 Products must be designed and manufactured in such a way as to reduce as much as possible the risks arising from the unintended incorporation of substances into the product, taking into account the product concerned and the type of product. The environment in which it is to be used.

8. Microbial infection and contamination.

8.1 Products and their manufacturing processes must be designed in such a way that the risk of infection to the patient, the user and third parties is eliminated or reduced as much as possible. The design shall allow for easy handling and, whenever indicated, to minimise the contamination of the product by the patient or vice versa during use.

8.2 Animal tissues must come from animals which have been subjected to appropriate veterinary checks and follow-up in the light of the use to which such tissues are intended.

The notified bodies shall keep data on the geographical origin of the animals.

Animal tissues, cells and substances of animal origin shall be transformed, preserved, analysed and manipulated in such a way as to provide maximum security guarantees. In particular, in order to provide guarantees that they are free of viruses and other transmissible agents, recognised methods of viral removal or inactivation will be used during the manufacturing process.

8.3 Products supplied in a sterile state must be designed, manufactured and conditioned in a non-reusable package or in accordance with appropriate procedures in such a way as to be sterile at the time of placing on the market and maintain this quality in the intended storage and transport conditions until the protective package which ensures sterility deteriorates or is opened.

8.4 Products supplied in a sterile state must be manufactured and sterilized by an appropriate and validated method.

8.5 Products that need to be sterilized must be manufactured in adequately controlled conditions (for example, those relating to the environment).

8.6 Packaging systems for non-sterile products must be such that they retain the product without deterioration in the intended state of cleaning and, if the product is to be sterilised before use, they must be minimise the risk of microbial contamination; the packaging system shall be appropriate, depending on the sterilisation method indicated by the manufacturer.

8.7 The packaging or labelling of the product must allow the identical or similar products sold at the same time in sterile and non-sterile form to be distinguished.

9. Properties related to manufacturing and the environment.

9.1 When the product is intended for use in combination with other products or equipment, the combination, including the union system, shall be safe and not alter the intended performance. Any restriction of use shall be on the label or on the instructions for use.

9.2 Products must be designed and manufactured in such a way as to eliminate or reduce as much as possible:

the risks of injuries related to their physical characteristics, including the volume/pressure ratio, the dimensional and, where applicable, ergonomic characteristics;

risks linked to reasonably foreseeable environment conditions such as magnetic fields, external electrical influences, electrostatic discharges, pressure, temperature or pressure variations or acceleration;

risks of reciprocal interference with other products, commonly used for research or treatment performed;

the risks arising, in the event of impossibility of maintenance or calibration (e.g. in the case of implantable products), of the ageing of the materials used or of the loss of precision of a mechanism of measurement or control.

9.3 Products must be designed and constructed in such a way that in the event of the use of fire or explosion risks in the case of normally used and first defect conditions. Particular attention must be paid to products intended to be used for the purpose of exposure to flammable substances or to substances capable of promoting combustion.

10. Products with measurement function.

10.1 Measurement-function products shall be designed and constructed in such a way as to provide sufficient accuracy and accuracy of measurement within the accuracy limits appropriate to the purpose of the product. The accuracy limits shall be indicated by the manufacturer.

10.2 The scale of measurement, control and display shall be designed according to ergonomic principles which take into account the purpose of the product.

10.3 The measurements made by the products with a measuring function must be expressed in legal units in accordance with the provisions of Council Directive 80 /181/EEC of 20 December 1979 on the approximation of the laws of the Member States relating to: of the laws of the Member States relating to units of measurement.

11. Radiation protection.

11.1 General requirements.

11.1.1 Products must be designed and manufactured in such a way as to reduce to a minimum compatible with the intended purpose any exposure of patients, users and other persons to radiation, without limit the application of appropriate levels that are indicated for therapeutic and diagnostic purposes.

11.2 Deliberate Radiation.

11.2.1 When products are designed to emit hazardous levels of radiation necessary for a specific medical purpose whose benefit is considered to be higher than the risks inherent in emissions, these will have to be user-controllable. Such products shall be designed and constructed in such a way as to ensure reproducibility and tolerance of the relevant variable parameters.

11.2.2 When products are intended to emit potentially hazardous, visible and/or invisible radiations, they shall be equipped, if possible, with visual and/or sound indicators that signal the emission of radiation.

11.3 Unintended Radiation.

11.3.1 Products must be designed and constructed in such a way as to minimise the exposure of patients, users and others to emissions of unintended, parasitic or dispersed radiation.

11.4 Usage Instructions.

11.4.1 Instructions for the use of radiation emitting products shall include detailed information on the characteristics of the radiation emitted, the means of protection of the patient and the user and the forms of radiation. to avoid mishandling and to eliminate the risks arising from the installation.

11.5 Ionising Radiation.

11.5.1 As far as possible, products emitting ionising radiation must be designed and constructed in such a way that the quantity, geometry and quality of the radiation emitted as a function can be regulated and controlled. of the target being pursued.

11.5.2 Products emitting ionising radiation for radiological diagnosis must be designed and manufactured to ensure a good quality of image and/or result according to the medical purpose to be pursued, with a minimum exposure of the patient and the user to radiation.

11.5.3 Products emitting ionising radiation intended for radiation therapy must be designed and manufactured in such a way as to enable reliable monitoring and control of the doses administered, of the type of beam, of the energy and, where appropriate, the type of radiation.

12. Requirements for medical devices connected to a power source or equipped with a power source.

12.1 Products incorporating programmable electronic systems shall be designed in such a way as to ensure the repeatability, reliability and effectiveness of such systems, in line with the use of such systems. intended. In the case of conditions of first defect in the system, the means must be provided in order to eliminate or reduce as far as possible the risks involved.

12.1 bis For products incorporating software or medical software, such software must be validated according to the current state of the art, taking into account the principles of lifecycle development, risk management, validation and verification.

12.2 Products possessing an internal energy source of which the safety of patients is dependent must be provided with a means to determine the state of the energy source.

12.3 The products connected to an external energy source from which the patient's safety depends must include an alarm system that signals any failure of the power source.

12.4 Products intended to monitor one or more clinical parameters of a patient must be equipped with appropriate alarm systems that allow the user to be notified of situations that may lead to death or a serious deterioration of the patient's health condition.

12.5 Products should be designed and constructed in such a way as to minimise the risks of creating electromagnetic fields that could affect the operation of other products or equipment located in their normal environment.

12.6 Protection against electrical hazards. -Products must be designed and manufactured in such a way that, when properly installed and used normally or in conditions of first defect, they are avoided as far as possible. possible risks of accidental electrical shock.

12.7 Protection against mechanical and thermal hazards.

12.7.1 Products must be designed and manufactured in such a way that the patient and the user are protected from related mechanical hazards, for example, with resistance, stability and moving parts.

12.7.2 Products must be designed and manufactured in such a way that the risks arising from the vibrations produced by the products are reduced to the lowest possible level, taking into account technical progress and the availability of means of reducing vibration, especially at source, unless the vibrations are part of the intended performance.

12.7.3 Products must be designed and constructed in such a way that the risks arising from noise emission are minimised, taking into account technical progress and the availability of noise reduction means, in particular at their origin, except where the noise emissions are part of the intended performance.

12.7.4 Terminals and devices for connection to electrical, hydraulic, pneumatic or gaseous energy sources which must be handled by the user must be designed and constructed in such a way as to reduce the minimum any possible risk.

12.7.5 The accessible parts of the products (excluding parts or areas intended to provide heat or to reach certain temperatures) and their environment must not reach temperatures that can represent a hazard under normal use conditions.

12.8 Protection against the risks that energy sources or substance administration may present to the patient.

12.8.1 The design and construction of products intended to provide energy or substances to the patient must be such that the input can be regulated and maintained with sufficient precision to ensure the safety of the patient. patient and user.

12.8.2 The product must be provided with means to prevent and/or to indicate any correction of the rate of supply of the product when there is a danger to it. -Products must be equipped with means adequate to prevent the accidental release of dangerous quantities of energy from a source of energy and/or substances, as far as possible.

12.9 The function of the controls and indicators must be clearly indicated in the products. -In case a product is accompanied by instructions necessary for its use or indications of control or control a visual system, such information shall be comprehensible to the user and, if appropriate, to the patient.

13. Data provided by the manufacturer.

13.1 Each product must be accompanied by the information necessary for its use in full safety and security, taking into account the training and knowledge of potential users, and to identify the manufacturer.

This information shall be made up of the indications on the label and those contained in the instructions for use.

The data necessary for the use of the product in full safety must be provided, provided that it is feasible and appropriate, in the product itself and/or in a single package or, where appropriate, in the commercial package. If it is not feasible to individually pack each unit, this data shall be shown in instructions for use which accompany one or more products.

All products must include in their packaging the instructions for use. Exceptionally, these instructions shall not be required in the case of products of classes I and IIa, if the complete safety of their use can be ensured without the aid of such instructions.

13.2 Data may, where appropriate, take the form of symbols. The symbols and the identification colours to be used shall comply with the harmonised standards. If there is no standard in this field, the symbols and colours shall be described in the documentation accompanying the product.

13.3 The label must include the following data:

a) The name or the social reason and the address of the manufacturer. As regards products imported into the Community with a view to their distribution in the Community, the label, outer packaging or instructions for use must also include the name and address of the representative. authorised, where the manufacturer has no registered office in the Community.

b) The information strictly necessary to identify the product and contents of the packaging, in particular by users.

c) When appropriate, the word "sterile".

d) The code of the batch preceded by the word "batch" or serial number, as appropriate.

e) Where appropriate, the date before which the product is to be used for full security, expressed in year and month.

f) The indication, where appropriate, that the product is for single use only. The manufacturer's indication that the product is for single use should be uniform throughout the Community.

g) In the case of custom products, the indication "product-to-measure".

h) If this is a product intended for clinical investigations, the indication "exclusively for clinical investigations".

i) Specific storage and/or conservation conditions.

j) Special instructions for use.

k) Any warning and/or caution to be taken.

l) The year of manufacture for the active products not referred to in point (e) above. This indication may be included in the batch or serial number.

m) When appropriate, the sterilization method.

(n) In the case of one of the products referred to in Article 3 (5), an indication that the product contains as an integral part a substance derived from human blood.

13.4 If the intended purpose of a product is not apparent to the user, the manufacturer must clearly indicate it on the label and on the instructions for use.

13.5 The products and their separable components shall be identified, where appropriate, in terms of lots, if this is reasonably practicable, in order to allow for any appropriate measure for the detection of a possible risk. concerning products and their separable components.

13.6 The instructions for use should include, as appropriate, the following data:

(a) The particulars referred to in paragraph 13.3, except those referred to in points (d) and (e).

(b) The benefits referred to in paragraph 3 and any unwanted side effects.

(c) When a product is to be installed with or attached to other medical devices or equipment to operate in accordance with its intended purpose, sufficient information on its characteristics shall be included for the product. identify the correct products or equipment to be used for a safe combination.

(d) All data to verify whether the product is properly installed and capable of functioning properly and safely, as well as data relating to the nature and frequency of maintenance operations and calibration to be performed to ensure the smooth operation and safety of the products.

e) The useful information to avoid, if any, certain risks related to the implementation of the product.

f) Information regarding risks of reciprocal interference related to the presence of the product in specific investigations or treatments.

g) The necessary instructions in the event of a break in the sterility protective package and, where appropriate, the appropriate methods of resterilisation.

(h) If a product is intended for reuse, data on appropriate procedures for reuse, including cleaning, disinfection, conditioning and, where appropriate, the method of sterilisation if the product is to be re-used must be resterilized, as well as any limitation regarding the number of reuses.

In case the products must be sterilized before use, the cleaning and sterilisation instructions must be formulated so that if they are properly followed, the product will continue to meet the requirements of the Part I.

If the product contains the indication that the product is for single use, the information on known characteristics and the technical factors known to the manufacturer that could pose a risk if the product is use again. If instructions for use are not required in accordance with paragraph 13.1, the information shall be provided to the user upon request.

i) Information about any further treatment or manipulation to be performed before using the product (e.g. sterilization, final assembly, etc.).

(j) When a product emits radiation for medical purposes, information concerning the nature, type, intensity and distribution of such radiation.

Instructions for use should also include information that allows medical staff to inform the patient about the contraindications and precautions to be taken. This information will particularly refer to:

k) The precautions to be taken in case of changes in the operation of the product.

(l) The precautions to be taken with regard to exposure, under reasonably foreseeable environmental conditions, to magnetic fields, to external electrical influences, to electrostatic discharges, to pressure or pressure variations, acceleration, thermal ignition sources, etc.

m) sufficient information on the medicinal product or medicinal products to be administered by the product concerned, including any restrictions on the choice of substances to be supplied.

n) The precautions to be taken if a product presents a specific unusual risk associated with its disposal.

(o) medicinal products or substances derived from human blood included in the product as an integral part of the product in accordance with paragraph 7.4.

p) The degree of accuracy attributed to measurement products.

q) The publication date of the latest revision of the instructions for use.

ANNEX II

EC Declaration of Compliance

(Full Quality Assurance System)

1. The manufacturer shall ensure that the approved quality system is applied for the design, manufacture and final control of the medical devices concerned, as provided for in paragraph 3, and shall be subject to the audit refer to paragraphs 3.3 and 4 and to the EC control as set out in paragraph 5.

2. The EC declaration of conformity is the procedure whereby the manufacturer who fulfils the obligations imposed by point 1 ensures and declares that the products in question comply with the provisions of this royal decree which are applicable.

The manufacturer shall affix the CE marking in accordance with Article 12 and make a written declaration of conformity. The declaration shall refer to one or more manufactured medical devices, clearly identified by the product name, product code or other unambiguous reference, and must be retained by the manufacturer.

3. Quality system.

3.1 The manufacturer shall submit to a notified body an application for the assessment of its quality system.

This request must contain:

The name and address of the manufacturer and any other manufacturing premises included in the quality system.

All relevant information about the products or category of products that are the subject of the procedure.

A written statement specifying that no parallel application concerning the same quality system linked to the product has been submitted to another notified body.

The documentation for the quality system.

A commitment on the part of the manufacturer to meet the obligations arising from the approved quality system.

A commitment on the part of the manufacturer to ensure that the approved quality system maintains its adequacy and effectiveness.

A commitment, by the manufacturer, to establish and maintain an updated systematic procedure to review the experience gained with products in the post-production phase, including the provisions to which refers to Annex X and to use the appropriate means to implement the necessary corrective measures. The undertaking shall include the obligation, on the part of the manufacturer, to inform the competent authorities of the following facts as soon as they are aware of the following:

i. any malfunction or alteration of the characteristics or benefits, as well as any inadequacy of the labelling or instructions for use of a product which may give rise to or may have resulted in death or the health status of a patient or a user is seriously altered;

ii. any technical or health reason linked to the characteristics or performance of a product which, for the reasons set out in paragraph 1 above, has led the manufacturer to carry out a systematic action on products of the same product. type.

3.2 The application of the quality system must ensure the conformity of the products with the applicable provisions of this royal decree in all phases, from the design to the final controls. All the elements, requirements and provisions adopted by the manufacturer for its quality system shall be entered in a systematic and orderly documentation in the form of written policies and procedures. This documentation on the quality system shall allow for a uniform interpretation of quality conditions and procedures, such as quality programmes, plans, manuals and records.

Include, in particular, the documents, data and records derived from the procedures referred to in point (c).

In particular, you must contain an appropriate description of:

a) The quality objectives of the manufacturer.

b) The organization of the company, in particular:

The organisational structures, responsibilities of managers and their organisational authority in terms of design quality and product manufacturing.

The methods for monitoring the effective functioning of the quality system and, in particular, its suitability to give rise to the desired level of quality of design and products, including the control of non-compliant products.

The methods of monitoring the effectiveness of the operation of the quality system, in particular the type and extent of the control applied to the third party in question, in case it is a third party who performs the design, manufactures and/or carries the final inspection and testing of the products or their components.

(c) The procedures for checking and verifying the design of the products, including the relevant documentation, and in particular:

A general description of the product, including the intended variants and their intended purpose or purposes.

Design specifications, including applicable rules and risk analysis results, as well as the description of the solutions adopted to meet the essential requirements applicable to products where the rules referred to in Article 6 are not applied in full.

The design verification and verification techniques, procedures and systematic measures to be applied in the design phase of the products.

When the product has to be connected to another or other products in order to be able to function according to its intended purpose, the proof that the product conforms to the essential requirements once connected with any of those products products having the characteristics specified by the manufacturer.

A statement indicating whether the product contains, as an integral part, a substance or a human blood derivative of those referred to in Section 7.4 of Annex I, as well as the data relating to the tests performed on the for the purpose of assessing the safety, quality and usefulness of the substance or the human blood derivative, taking into account the intended purpose of the product.

A statement indicating whether or not the tissue product of animal origin has been used in the manufacture of the product in accordance with Annex XIII to this royal decree.

The solutions adopted pursuant to Annex I, Title I, point 2.

The preclinical evaluation.

The clinical assessment referred to in Annex X.

The label model and, if any, instructions for use.

d) Quality assurance and control techniques in manufacturing and in particular:

processes and procedures, to be used, in particular in the field of sterilization and purchase, and relevant documents,

the product identification procedures adopted and updated, from drawings, specifications or other relevant documents, throughout all manufacturing phases.

e) appropriate studies and tests to be carried out before, during and after production, the frequency with which they are to be carried out and the test equipment to be used; the calibration must be properly checked of test equipment.

3.3 The notified body shall carry out an audit of the quality system to determine whether it meets the requirements referred to in paragraph 3.2. It shall provide for compliance with those requirements if the quality systems comply with the relevant harmonised standards.

At least one of the members of the team in charge of the assessment should have experience in evaluations within the technological field concerned. The assessment procedure shall include a representative assessment of the documentation relating to the design of the product or products concerned, an inspection of the manufacturer's premises, and in justified cases, of the facilities the manufacturer's suppliers and/or subcontractors to inspect the manufacturing processes.

The decision shall be notified to the manufacturer and shall include the findings of the inspection and a reasoned assessment.

3.4 The manufacturer shall inform the notified body that it has approved the quality system of any major modification of the quality system or the range of products included. The notified body shall evaluate the proposed amendments and check whether the quality system thus amended continues to meet the requirements referred to in paragraph 3.2. it shall notify the manufacturer of its decision. That decision shall include the findings of the inspection and a reasoned assessment.

4. Examination of the product design.

4.1 The manufacturer shall, in addition to its obligations under paragraph 3, submit to the notified body a request for examination of the design dossier for the product to be manufactured and to be part of the of the category referred to in paragraph 3.1

4.2 The application shall describe the design, manufacture and performance of the medical device concerned and shall include the necessary documents referred to in paragraph 3.2 (c) to enable the conformity to be judged with the requirements of this royal decree.

4.3 The notified body shall examine the application and, if the product complies with the requirements of this royal decree which are applicable, it shall issue an EC design examination certificate to the applicant. The notified body may require the application to be completed with additional testing or testing, so that compliance with the requirements of this provision can be assessed. The certificate shall contain the conclusions of the examination, the conditions of validity, the data necessary for the identification of the approved design and, where appropriate, a description of the purpose of the product.

In the case of the products referred to in the second paragraph of point 7.4 of Annex I, the notified body shall, as regards the aspects referred to in that point, consult one of the competent authorities designated by the the Member States in accordance with Directive 2001 /83/EC or the EMEA before taking a decision. The opinion of the national competent authority or the EMEA shall be drawn up within 210 days of receipt of the valid documentation. The scientific opinion of the national competent authority or the EMEA shall be included in the product documentation. When taking its decision, the notified body shall take due account of the opinions issued with regard to its consultation and shall inform the relevant competent body of its final decision.

In the case of products listed in the third paragraph of point 7.4 of Annex I, the scientific opinion of the EMEA shall be included in the product documentation. This opinion shall be drawn up within 210 days of receipt of the valid documentation. When adopting its decision, the notified body shall take due account of that opinion. The notified body may not issue the certificate if the opinion of the EMEA is unfavourable. It will communicate to the EMEA its final decision.

In the case of products in the manufacture of which tissues of animal origin are used, the notified body shall follow the procedures provided for in Article 20 of this royal decree.

4.4 The modifications to the approved design must be approved in addition to the notified body which has issued the EC design examination certificate, where such modifications may affect the design of the design. compliance with the essential requirements of this provision or with the conditions laid down for the use of the product. The applicant shall inform the notified body which has issued the EC examination certificate of the design of any modification which has been introduced in the approved design. Supplementary approval shall be granted in the form of an appendix to the EC design examination certificate.

5. Control.

5.1 The purpose of the control is to ensure the correct compliance by the manufacturer of the obligations arising from the approved quality system.

5.2 The manufacturer shall authorise the notified body to carry out all necessary inspections and shall provide it with all relevant information, in particular:

The documentation for the quality system.

The data provided for in the part of the quality system relating to the design, for example the results of the analyses, calculations, tests, solutions adopted in accordance with Annex I, Title I, point 2, the assessment preclinical and clinical, the post-marketing clinical follow-up plan, the results of this follow-up, if appropriate, etc.

The data provided for in the part of the quality system relating to manufacturing, such as the reports for inspections, tests, calibrations, the qualification of the staff concerned, etc.

5.3 The notified body shall carry out regular inspections and assessments in order to ensure that the manufacturer applies the approved quality system and shall provide an assessment report to the manufacturer.

5.4 The notified body may also visit without notice to the manufacturer. On the occasion of such visits, the notified body may carry out or have tests carried out to verify the proper functioning of the quality system, if it is deemed necessary, and shall provide the manufacturer with an inspection report and, if a test has been conducted, a test report.

6. Administrative provisions.

6.1 The manufacturer or his authorised representative must be at the disposal of the national authorities for a period of not less than five years and, in the case of implantable products, at least 15 years later that the last product has been manufactured:

the compliance declaration,

the documentation referred to in the fourth indent of paragraph 3.1, and in particular the documents, data and records referred to in the second paragraph of point 3.2.

the modifications referred to in section 3.4,

the documentation referred to in section 4.2, and

the notified body's decisions and reports referred to in paragraphs 3.3, 4.3, 4.4, 5.3 and 5.4.

7. Application to the products of classes IIa and IIb.

7.1 This Annex may be applied, in accordance with Article 13 (1) (b) and (c), to products of classes IIb and IIa. However, the provisions of paragraph 4 shall not apply.

7.2 For products of Class IIa, the notified body shall evaluate, as part of the assessment referred to in point 3.3, the technical documentation described in point 3.2 (c) at least in respect of a sample representative of each sub-category of products, as regards compliance with the provisions of this royal decree.

7.3 For products of Class IIb, the notified body shall assess, as part of the assessment referred to in point 3.3, the technical documentation described in point 3.2 (c) at least in respect of a sample representative of each generic group, as far as compliance with the provisions of this royal decree is concerned.

7.4 To choose the representative sample (s), the notified body will take into account the novelty of the technology, the design similarities, the technology, the methods of manufacture and sterilization, the intended purpose and the results of the relevant previous assessments (e.g. physical, chemical or biological properties) carried out in accordance with this royal decree. The notified body shall document and make available to the competent authority the grounds on which it is based to collect the sample (s).

7.5 The notified body shall evaluate other samples as part of the control assessment referred to in point 5.

8. Application to the products referred to in Article 3 (5).-At the end of the manufacture of each batch of products referred to in Article 3 (5), the manufacturer shall inform the notified body of the release of the batch of products referred to in Article 3 (5). products and shall transmit the official certificate of release of the batch of substances derived from human blood used in that product, issued by a state laboratory or a laboratory designated for that purpose by a Member State, in accordance with the Article 114 (2) of Directive 2001 /83/EC.

ANNEX III

EC type examination

1. The EC type-examination is the procedure whereby a notified body checks and certifies that a representative sample of the production concerned complies with the provisions of this royal decree.

2. The application must include:

the name and address of the manufacturer, as well as the name and address of your authorised representative in case it is the person who submits the application;

the documentation referred to in paragraph 3, which is necessary in order to be able to assess the conformity of the representative sample of the production concerned, hereinafter referred to as 'type', with the requirements of this provision. The applicant shall make a 'type' available to the notified body. The notified body may request other copies if necessary;

a written statement specifying that no request concerning the same type has been submitted to another notified body.

3. The documentation shall enable the design, manufacture and performance of the product to be understood. It shall include, in particular, the following elements:

A general description of the type, including the expected variants, and their intended purpose or purposes.

Design drawings, intended manufacturing methods, in particular for sterilization, component schemes, subassemblies, circuits, and so forth.

The descriptions and explanations required for the understanding of the mentioned drawings and schemes and the operation of the product.

A list of the rules referred to in Article 6, applied in whole or in part, as well as the description of the solutions adopted to meet the essential requirements when the standards referred to are not fully applied in Article 6.

The results of the design calculations, risk analysis, research, technical tests, etc., that have been performed.

A statement indicating whether the product contains, as an integral part, a substance or a derivative of human blood as referred to in paragraph 7.4 of Annex I, as well as the data relating to the tests performed on the as regards the safety, quality and usefulness of the substance or the human blood derivative concerned, taking into account the intended purpose of the product.

A statement indicating whether or not the tissue product of animal origin has been used in the manufacture of the product in accordance with Directive 2003 /32/EC.

The solutions adopted pursuant to Annex I, Title I, point 2.

The preclinical evaluation.

The clinical assessment referred to in Annex X.

The tag project and, if any, instructions for use.

4. The notified body.

4.1 Examine and evaluate the documentation and verify that the type has been manufactured in accordance with it; it shall also indicate the elements that have been designed in accordance with the applicable provisions of the standards. referred to in Article 6, as well as the elements whose design is not based on the relevant provisions of those rules.

4.2 It shall carry out or make appropriate checks and tests to check whether the solutions adopted by the manufacturer comply with the essential requirements of this provision, where the rules do not apply. referred to in Article 6; where a product is to be connected to another product or products in order to function in accordance with its intended purpose, it must be proved that the first product meets the essential requirements when it is connected to the products possessing the characteristics indicated by the manufacturer.

4.3 It shall carry out or make appropriate checks and tests to check whether, if the manufacturer has decided to apply the relevant rules, they have actually been applied.

4.4 Acordara to the applicant for the place where the necessary controls and tests are to be carried out.

5. Where the type complies with the provisions of this royal decree, the notified body shall issue the applicant with an EC-type examination certificate. The certificate shall contain the name and address of the manufacturer, the conclusions of the inspection, the conditions of validity of the certificate and the data necessary for the identification of the approved type. The relevant parts of the documentation shall be attached to the certificate; a copy shall be kept by the notified body.

In the case of the products referred to in the second subparagraph of point 7.4 of Annex I, the notified body shall, as regards the aspects referred to in that point, consult one of the designated competent authorities. by Member States in accordance with Directive 2001 /83/EC or the EMEA before taking a decision. The opinion of the national competent authority or the EMEA shall be drawn up within 210 days of receipt of the valid documentation. The scientific opinion of the national competent authority or the EMEA shall be included in the product documentation. The notified body shall take due account of the views expressed in the consultation when taking its decision. It shall communicate its final decision to the competent body concerned.

In the case of products listed in the third paragraph of point 7.4 of Annex I, the scientific opinion of the EMEA shall be included in the product documentation. The opinion of the EMEA shall be drawn up within 210 days of receipt of the valid documentation. When adopting its decision, the notified body shall take due account of that opinion. The notified body may not issue the certificate if the opinion of the EMEA is unfavourable. It will communicate to the EMEA its final decision.

In the case of products in the manufacture of which products of animal origin are used. The notified body shall follow the procedures provided for in Article 20 of this royal decree.

6. The applicant shall inform the notified body that it has issued the EC type-examination certificate on any major modification to the approved product.

When modifications made to the approved type may affect their conformity with the essential requirements or with the intended conditions of use of the product, the notified body which has issued the EC type-examination certificate shall also approve such amendments. This additional approval shall be issued, where appropriate, in the form of an appendix to the initial EC type-examination certificate.

7. Administrative provisions.

7.1 The other notified bodies may obtain a copy of the EC type-examination certificates and their appendices. The appendices of the certificates shall be made available to the other notified bodies which submit a reasoned request on the basis of information to the manufacturer.

7.2 The manufacturer or his authorised representative shall keep a copy of the EC type-examination certificates and their supplements together with the technical documentation for a period of at least five years from the date of the date of manufacture of the last product. In the case of implantable products, the period shall be at least 15 years after the last product has been manufactured.

ANNEX IV

CE Verification

1. EC verification is the procedure by which the manufacturer or his authorised representative ensures and declares that the products referred to in paragraph 4 are in conformity with the type described in the EC type-examination certificate and comply with the requirements of the the requirements of this royal decree that apply to you.

2. The manufacturer shall take the necessary measures to ensure that the manufacturing process ensures the conformity of the products with the type described in the EC type-examination certificate and with the requirements of this royal decree applicable to them. Prior to the start of manufacture, a documentation shall be drawn up in which the manufacturing processes are defined, in particular, where appropriate, as regards sterilisation, as well as the set of pre-established provisions and (a) systematic application to ensure the homogeneity of production and, where appropriate, the conformity of the products with the type described in the EC type-examination certificate and with the requirements of this royal decree applicable. It shall apply the CE marking in accordance with Article 12 and make a declaration of conformity.

In addition, in the case of products placed on the market under sterility conditions, and only for aspects of manufacture intended to obtain the condition of sterility and its maintenance, the manufacturer apply the provisions of points 3 and 4 of Annex V.

3. The manufacturer shall undertake to establish and maintain updated a systematic procedure to review the experience acquired with the products in the post-production phase, including the provisions referred to in Annex X and for use the appropriate means to implement the necessary corrective measures. The undertaking shall include the obligation, on the part of the manufacturer, to inform the competent authorities of the following facts as soon as they are aware of the following:

i. Any malfunction or alteration of the characteristics or performance, as well as any inadequacy of the labelling or instructions for use of a product which may give rise to or may have resulted in death or the health status of a patient or a user is seriously altered.

ii. Any technical or health reason linked to the characteristics or performance of a product for the reasons set out in the previous paragraph i have induced the manufacturer to carry out a systematic action on products of the same type.

4. The notified body shall carry out appropriate examinations and tests in order to verify the conformity of the product with the requirements of this royal decree, either by checking and testing each product as specified in paragraph 5 or by means of control and testing of the products in statistical form as specified in point 6, at the choice of the manufacturer.

The verifications referred to above shall not apply in respect of the manufacturing aspects related to the obtaining of sterility.

5. Verification by control and testing of each product.

5.1 All products shall be individually examined and the appropriate tests, as defined in the applicable standard or standards referred to in Article 6 or equivalent tests, shall be carried out in order to verify their conformity, where appropriate, with the type described in the EC type-examination certificate and with the requirements of this royal decree which apply to them.

5.2 The notified body shall place or make its identification number on each approved product and issue a written certificate of conformity for the tests carried out.

6. Statistical verification.

6.1 The manufacturer shall present the products manufactured in the form of homogeneous lots.

6.2 A random sample will be taken from each batch. The products constituting the sample shall be individually examined and, in order to verify their conformity, where appropriate, with the type described in the EC type-examination certificate and with the applicable requirements of the royal decree, the relevant tests as defined in the applicable standard or standards referred to in Article 6, or equivalent tests, in order to determine the acceptance or rejection of the lot.

6.3 The statistical control of the products will be carried out by properties and/or variables, which will involve sampling systems with operational characteristics that guarantee a high level of safety and performance according to the state of the technique. The sampling systems shall be determined in accordance with the harmonised standards referred to in Article 6, taking into account the specificity of the product categories concerned.

6.4 If a lot is accepted, the notified body shall place or make its identification number on each product and extend a written certificate of conformity for the tests carried out. All products in the lot may be placed on the market, except for the products of the sample which are not in conformity.

If a lot is rejected, the competent notified body shall take appropriate measures to prevent its placing on the market. In the event of frequent rejection of lots, the notified body may suspend the statistical verification.

The manufacturer may, under the responsibility of the notified body, place the latter's identification number during manufacture.

7. Administrative provisions. The manufacturer or his authorised representative must be at the disposal of the national authorities for a period of at least 5 years and, in the case of implantable products, of at least 15 years after he has been manufactured last product:

The compliance declaration.

The documentation referred to in point 2.

The certificates referred to in points 5.2 and 6.4.

Where appropriate, the type examination certificate referred to in Annex III.

8. Application to products of Class IIa. This Annex may be applied in accordance with Article 13 (1) (c) to products of Class IIa as follows:

8.1 By way of derogation from paragraphs 1 and 2, the manufacturer shall ensure and declare by means of the declaration of conformity that the products of Class IIa are manufactured in accordance with the technical documentation provided for in the Annex VII, paragraph 3, and meet the requirements of this royal decree that apply to them.

8.2 By way of derogation from paragraphs 1, 2, 5 and 6, the checks carried out by the notified body shall be subject to the conformity of the products of Class IIa with the technical documentation referred to therein. paragraph 3 of Annex VII.

9. Application to the products referred to in Article 3 (5).-In the case of paragraph 5, at the end of the manufacture of each batch of products referred to in Article 3 (5) and, in the case of the verification provided for in the paragraph 6, the manufacturer shall inform the notified body of the release of this batch of products and shall forward to it the official certificate of release of the batch of the human blood derivative used in that product issued by a laboratory (a) a state or a laboratory designated for that purpose by a Member State, in accordance with Article 114 (2) of the Directive 2001 /83/EC.

ANNEX V

EC Declaration of Compliance

(Production Quality Assurance)

1. The manufacturer shall ensure that the approved quality system is applied for the manufacture and shall carry out the final inspection of the products concerned as specified in paragraph 3 and shall be subject to the control referred to in paragraph 3. in paragraph 4.

2. The EC declaration of conformity is the procedure whereby the manufacturer who fulfils the obligations of point 1 ensures and declares that the products in question are in conformity with the type described in the EC type-examination certificate and adjust to the provisions of this royal decree that apply to them.

The manufacturer shall affix the CE marking in accordance with Article 12 and make a written declaration of conformity. This declaration shall relate to one or more manufactured medical devices, clearly identified by the name of the product, the product code or other unambiguous reference, and must be retained by the manufacturer.

3. Quality system.

3.1 The manufacturer shall submit an application for the assessment of his quality system to a notified body.

This request must contain:

The name and address of the manufacturer.

All relevant information about the products or categories of products that are the subject of the procedure.

A written statement specifying that no request for the same products has been submitted to another notified body.

The documentation for the quality system.

A commitment to meet the obligations arising from the quality system that is approved.

A commitment to maintain the approved quality system so that its adequacy and effectiveness are always guaranteed.

Where applicable, the technical documentation concerning the approved types and a copy of the EC type examination certificates.

A commitment on the part of the manufacturer to establish and maintain an updated systematic procedure to review the experience acquired with the products in the post-production phase, including the provisions to which refers to Annex X, and to use the appropriate means to implement the necessary corrective measures. The undertaking shall include the obligation, on the part of the manufacturer, to inform the competent authorities of the following facts as soon as they are aware of the following:

i. Any malfunction or alteration of the characteristics and/or performance, as well as any inadequacy of the labelling or instructions for use of a product which may give rise to or may have resulted in death or severe alteration of the health status of a patient or a user.

ii. Any technical or health reason linked to the characteristics or performance of a product for the reasons set out in the previous paragraph i have induced the manufacturer to carry out a systematic action on products of the same type.

3.2 The application of the quality system must ensure the conformity of the products with the type described in the EC type-examination certificate. -All the elements, requirements and provisions adopted by the manufacturer for its quality system shall be included in a systematic and orderly documentation in the form of written policies and procedures. The documentation of the quality system should enable a uniform interpretation of the policy and quality procedures applied, such as quality programmes, plans, manuals and records.

You must contain, in particular, an appropriate description of:

a) The quality objectives of the manufacturer.

b) The organization of the company and in particular:

Of the organizational structures, the responsibilities of the managers and their authority to the organization regarding the manufacture of the products.

The means to monitor the effective functioning of the quality system and, in particular, its ability to give rise to the desired level of product quality, including the control of non-compliant products.

The methods of monitoring the effectiveness of the operation of the quality system, in particular the type and extent of the control applied to a third party, in case it is a third party who manufactures and/or carries out the inspection final and the test of the products or their components.

c) Quality assurance and control techniques in the manufacturing process and, in particular:

of the processes and procedures to be used in relation to, in particular, sterilisation, procurement and relevant documents;

of the established and updated product identification procedures, from drawings, specifications or other applicable documents, throughout all manufacturing stages.

(d) The appropriate examinations and tests to be carried out before, during and after production, the frequency with which they are to be carried out and the test equipment used; the calibration of the test equipment must be such that can be properly checked.

3.3 The notified body shall carry out an audit of the quality system to determine whether it meets the requirements referred to in paragraph 3.2. It shall provide for compliance with those requirements if the quality systems comply with the relevant harmonised standards.

At least one of the team members in charge of the assessment should have experience in evaluating the technology in question. The assessment procedure shall include an inspection of the facilities of the manufacturer and, if duly justified, of the facilities of the manufacturer's suppliers, in order to control the manufacturing procedures.

The decision will be communicated to the manufacturer after the final inspection. The decision shall include the findings of the inspection and a reasoned assessment.

3.4 The manufacturer shall inform the notified body that the quality system has approved any major adaptation project of that system.

The notified body shall evaluate the proposed modifications and check whether the quality system thus amended meets the requirements referred to in paragraph 3.2.

The decision shall be notified to the manufacturer upon receipt of the above information and the findings of the inspection and a substantiated assessment shall be set out therein.

4. Control.

4.1 The purpose of the control is to ensure the correct compliance by the manufacturer of the obligations arising from the approved quality system.

4.2 The manufacturer shall authorise the notified body to carry out all necessary inspections and shall provide it with all relevant information, in particular:

the documentation on the quality system,

the technical documentation,

the data provided for in the part of the quality system relating to manufacturing, such as the reports concerning inspections, tests, calibrations, the qualification of the staff concerned, etc.

4.3 The notified body shall carry out regular inspections and assessments in order to ensure that the manufacturer applies the approved quality system and shall provide the manufacturer with an assessment report.

4.4 The notified body may also visit without notice to the manufacturer. On the occasion of such visits, the notified body may carry out or have tests carried out to verify the proper functioning of the quality system, where it considers it necessary and shall provide the manufacturer with an inspection report and, if have carried out a test, a test report.

5. Administrative provisions.

5.1 The manufacturer or his authorised representative shall have at the disposal of the national authorities for at least five years and in the case of implantable products, at least 15 years after the last one has been manufactured product:

the compliance declaration,

the documentation referred to in the fourth indent of paragraph 3.1,

the adaptations referred to in paragraph 3.4,

the documentation referred to in the seventh indent of paragraph 3.1,

the decisions and reports of the notified body referred to in paragraphs 4.3 and 4.4,

where applicable, the type examination certificate referred to in Annex III.

6. Application to products of Class IIa. This Annex may be applied in accordance with Article 13 (1) (c) to products of Class IIa as follows:

6.1 By way of derogation from paragraphs 2, 3.1 and 3.2, the manufacturer shall ensure and declare, by means of the declaration of conformity, that the products of Class IIa are manufactured in accordance with the technical documentation referred to in paragraph 3 of Annex VII, and comply with the requirements of this royal decree which apply to them.

6.2 For products of Class IIa, the notified body shall assess, as part of the assessment referred to in paragraph 3.3, the technical documentation described in paragraph 3 of Annex VII, at least in respect of a sample representative of each sub-category of products, as regards compliance with the provisions of this royal decree.

6.3 To choose the representative sample or samples, the notified body shall take into account the novelty of the technology, the design similarities, the technology, the methods of manufacture and sterilization, the intended purpose and the results of the relevant previous assessments (e.g. physical, chemical or biological properties) carried out in accordance with this royal decree. The notified body shall document and make available to the competent authority the grounds on which it is based to choose the sample or samples.

6.4 The notified body shall evaluate other samples as part of the control assessment referred to in paragraph 4.3

7. Application to the products referred to in Article 3 (5).-At the end of the manufacture of each batch of products referred to in Article 3 (5), the manufacturer shall inform the notified body of the release of the batch of products referred to in Article 3 (5). products and shall forward to it an official certificate for the release of the batch of substances derived from human blood used in that product, issued by a state laboratory or a laboratory designated for that purpose by a Member State, on the basis of Article 114 (2) of Directive 2001 /83/EC.

ANNEX VI

EC Declaration of Compliance

(Product Quality Assurance)

1. The manufacturer shall ensure that the approved quality system for the final inspection of the product and the tests, as specified in paragraph 3, is applied and shall be subject to the control referred to in paragraph 4.

In addition, in the case of products placed on the market under sterility conditions, and only for aspects of manufacture intended to obtain the condition of sterility and its maintenance, the manufacturer apply the provisions of paragraphs 3 and 4 of Annex V.

2. The EC declaration of conformity is the procedure whereby the manufacturer who fulfils the obligations imposed by paragraph 1 ensures and declares that the products in question are in conformity with the type described in the EC examination certificate of type and conform to the provisions of the royal decree that apply to them.

The manufacturer shall affix the CE marking in accordance with Article 12 and make a written declaration of conformity. This declaration shall relate to one or more manufactured medical devices, clearly identified by the name of the product, product code or other unambiguous reference and must be retained by the manufacturer. The CE marking shall be accompanied by the identification number of the notified body performing the functions referred to in this Annex.

3. Quality system.

3.1 The manufacturer shall submit an application for the assessment of his quality system to a notified body.

This request must contain:

The name and address of the manufacturer.

All relevant information about the products or category of products that are the subject of the procedure.

A written statement specifying that no request for the same products has been submitted to another notified body.

The documentation for the quality system.

A commitment by the manufacturer to meet the obligations arising from the quality system that is approved.

A commitment by the manufacturer to ensure that the approved quality system continues to be adequate and effective.

Where applicable, the technical documentation concerning the approved types and a copy of the EC type examination certificates.

The manufacturer's commitment to establish and keep up to date a systematic procedure to review the experience gained with products in the post-production phase including the provisions to which it is refers to Annex X, and to use the appropriate means to implement the necessary corrective measures. The undertaking shall include the obligation, on the part of the manufacturer, to inform the competent authorities of the following facts as soon as they are aware of the following:

i. Any malfunction or alteration of the characteristics or performance, as well as any inadequacy of the labelling or instructions for use of a product which may give rise to or may have resulted in death or the health status of a patient or a user is seriously altered.

ii. Any technical or health reason linked to the characteristics or performance of a product for the reasons set out in the previous paragraph i have induced the manufacturer to carry out a systematic action on products of the same type.

3.2 According to the quality system, each product or representative sample of each batch shall be examined and the appropriate tests defined in the relevant standard or standards referred to in Article 6 shall be carried out; or equivalent tests, in order to ensure their conformity with the type described in the EC type-examination certificate and with the applicable requirements of this royal decree. All the elements, requirements and provisions adopted by the manufacturer shall appear in a systematic and orderly documentation in the form of written measures, procedures and instructions. This documentation on the quality system will allow for a uniform interpretation of quality programmes, plans, manuals and dossiers.

In particular, it will include an appropriate description of:

quality objectives, organizational structure the responsibilities of managers and their powers in terms of product quality;

the controls and tests to be carried out after the manufacture of the calibration of the test equipment must be such that it can be adequately checked;

means to verify the effective operation of the quality system;

quality records, such as inspection reports and test data, calibration data, reports on the corresponding personnel qualification, etc.

the methods of monitoring the effectiveness of the operation of the quality system, in particular the type and extent of the control applied to the third party concerned, in case it is a third party carrying out the final inspection and the testing of the products or their components.

The verifications referred to above shall not apply to manufacturing aspects related to the obtaining of sterility.

3.3 The notified body shall carry out an audit of the quality system to determine whether it meets the requirements referred to in paragraph 3.2. It will of course comply with those requirements if the quality systems apply the relevant harmonised standards.

At least one of the team members in charge of the assessment should have experience in evaluating the technology in question. The assessment procedure shall include an inspection of the facilities of the manufacturer and, where justified, of the facilities of the manufacturer's suppliers, in order to control the manufacturing procedures.

The decision shall be communicated to the manufacturer and shall include the findings of the control and a reasoned assessment.

3.4 The manufacturer shall inform the notified body that the quality system has approved any major adaptation project of that system.

The notified body shall evaluate the proposed modifications and check whether the quality system thus amended meets the requirements referred to in paragraph 3.2.

The decision shall be notified to the manufacturer upon receipt of the above information and the conclusions of the control and a reasoned assessment shall be set out therein.

4. Control.

4.1 The purpose of the control is to ensure the correct compliance by the manufacturer of the obligations arising from the approved quality system.

4.2 The manufacturer shall authorise the notified body to access, in order to inspect, the inspection, testing and storage facilities and shall provide it with all relevant information, in particular:

the documentation on the quality system;

the technical documentation;

quality records, such as reports concerning inspections and test data, calibration data, reports on the qualification of the staff concerned, etc.

4.3 The notified body shall carry out regular inspections and assessments in order to ensure that the manufacturer applies the quality system, and shall provide an assessment report to the manufacturer.

4.4 The notified body may also visit without notice to the manufacturer. On the occasion of such visits, the notified body may, if it considers it necessary, carry out tests to verify the proper functioning of the quality system and the conformity of production with the requirements of this system. royal decree that apply to you. To this end, a suitable sample of finished products, taken on site by the notified body, shall be checked and the appropriate tests defined in the applicable standard or standards referred to in Article 6 or equivalent tests shall be carried out. Where one or more copies of the controlled products are not in conformity, the notified body shall take appropriate measures.

The notified body shall provide the manufacturer with an inspection report and, where appropriate, a test report.

5. Administrative provisions.

5.1 The manufacturer or his authorised representative shall have at the disposal of the national authorities for a period of at least five years and, in the case of implantable products, at least 15 years after he has been manufactured last product:

the compliance declaration,

the documentation referred to in the seventh indent of paragraph 3.1.

the adaptations referred to in paragraph 3.4,

the notified body's decisions and reports referred to in the last subparagraph of paragraph 3.4 and in paragraphs 4.3 and 4.4,

where applicable, the certificate of conformity referred to in Annex III.

6. Application to products of Class IIa. This Annex may be applied in accordance with Article 13 (1) (c) to products of Class IIa as follows:

6.1 By way of derogation from paragraphs 2, 3.1 and 3.2, the manufacturer shall ensure and declare, by means of the declaration of conformity, that the products of Class IIa are manufactured in accordance with the technical documentation referred to above. in Annex VII, paragraph 3, and respond to the requirements of this royal decree that apply to them.

6.2 For products of Class IIa, the notified body shall assess, as part of the assessment referred to in paragraph 3.3, the technical documentation described in Annex VII, paragraph 3, at least in respect of a sample representative of each sub-category of products, as regards compliance with the provisions of this royal decree.

6.3 To choose the representative sample or samples, the notified body shall take into account the novelty of the technology, the design similarities, the technology, methods of manufacture and sterilisation, the intended purpose and the results of the relevant previous assessments (e.g. physical, chemical or biological properties) carried out in accordance with this royal decree. The notified body shall document and make available to the competent authority the grounds on which it is based to choose the sample or samples.

6.4 The notified body shall evaluate other samples as part of the assessment referred to in paragraph 4.3.

ANNEX VII

EC Declaration of Compliance

1. The EC declaration of conformity is the procedure whereby the manufacturer or his authorised representative who fulfils the obligations of paragraph 2 and, in the case of sterile products and those with a measuring function, those in paragraph 5, ensures and declares that the corresponding products comply with the provisions of this royal decree that apply to them.

2. The manufacturer shall prepare the technical documentation described in paragraph 3; the manufacturer or his authorised representative shall keep this documentation, including the declaration of conformity, at the disposal of the national authorities; inspection, for at least five years from the date of manufacture of the last product. In the case of implantable products, the period shall be at least 15 years after the last product has been manufactured.

3. The technical documentation shall make it possible to assess the conformity of the product with the requirements of this provision and shall include, in particular:

a general description of the product, including the intended variants; and its intended purpose or purposes;

design drawings, intended manufacturing methods, as well as schemas of components, subassemblies, circuits, etc.;

the descriptions and explanations necessary for the understanding of the drawings and schemes mentioned and the operation of the product;

the results of the risk analysis, as well as a list of the standards referred to in Article 6 applied in whole or in part, and a description of the solutions adopted to meet the essential requirements of the real a decree where the rules referred to in Article 6 are not applied in full;

for sterile products, a description of the methods used; and the validation report.

the results of the design calculations, the controls performed, etc. Where a product has to be connected to another or other products in order to function in accordance with its intended purpose, proof must be provided that the first product complies with the essential requirements when it is connected to any of those products. products having the characteristics indicated by the manufacturer;

solutions adopted in accordance with point 2 of Title I of Annex I;

the preclinical assessment;

the clinical assessment in accordance with Annex X;

the labels and instructions for use.

4. The manufacturer shall establish and keep up to date a systematic procedure for reviewing the experience acquired with the products in the post-production phase, including the provisions referred to in Annex X and for the use of the means appropriate to implement the necessary corrective measures, taking into account the nature and risks related to the product. The manufacturer shall inform the competent authorities of the following facts as soon as they are aware of the following:

i. Any malfunction or alteration of the characteristics or performance, as well as any inadequacy of the labelling or instructions for use of a product which may give rise to or may have resulted in death or the health status of a patient or a user is seriously altered.

ii. Any technical or health reason linked to the characteristics or performance of a product for the reasons set out in the previous paragraph i have induced the manufacturer to carry out a systematic action on products of the same type.

5. For products placed on the market under sterility conditions and for products with a measurement function of Class I, the manufacturer shall, in addition to the provisions of this Annex, follow one of the procedures laid down in this Annex. Annexes II, IV, V or VI. The application of the abovementioned Annexes and the intervention of the notified body shall be limited:

in the case of products placed on the market in sterility conditions, only in respect of the manufacturing aspects relating to the procurement and maintenance of sterility conditions;

in the case of products with a measurement function, only to the manufacturing aspects relating to the conformity of the products with the metrological requirements.

Paragraph 6.1 of this Annex shall apply.

6. Application to products of Class IIa. This Annex may be applied in accordance with Article 13 (1) (c) to products of Class IIa with the following exception:

6.1 Where this Annex applies in combination with the procedure referred to in Annexes IV, V or VI, the declaration of conformity referred to in paragraph 1 of this Annex and the declaration referred to in the other Annexes They shall constitute a single declaration. As regards the declaration based on this Annex, the manufacturer shall ensure and declare that the design of the product complies with the provisions of this royal decree which apply to it.

ANNEX VIII

Statement regarding products that have a special purpose

1. For custom products or products intended for clinical investigations, the manufacturer or his authorised representative shall draw up this declaration with the elements specified in paragraph 2.

2. The declaration shall contain the following

:

2.1 For custom products:

The name and address of the manufacturer.

Data to identify the product in question.

The claim that the product is intended to be used exclusively by a particular patient, and the name of that patient, an acronym, or a numerical code.

The name of the doctor or authorized person who has made the corresponding prescription and, where appropriate, the name of the health center.

The product-specific characteristics indicated in the prescription.

The declaration that the product concerned complies with the essential requirements set out in Annex I to this royal decree and, where appropriate, the indication of the essential requirements which have not been fully complied with, indicating the reasons.

2.2 For products for clinical research referred to in Annex X:

Data to identify the product in question.

The clinical research plan.

The Investigator's manual.

The confirmation of the insurance or other financial guarantee of the subjects of the trial, in the terms set out in Article 8 of Royal Decree 223/2004, of February 6.

The documents used to obtain informed consent.

A statement indicating whether or not the product incorporates as an integral part, a substance or a substance derived from human blood referred to in point 7.4 of Annex I.

A statement indicating whether or not the tissue product of animal origin has been used in the manufacture of the product in accordance with Annex XIII to this royal decree.

The opinion of the relevant ethics committee with an indication of the issues to be addressed.

The name of the physician or the person authorized for that purpose and the name of the institution responsible for the investigations.

The place, start date, and expected duration of the investigations.

A declaration stating that the product in question complies with the essential requirements, with the exception of the aspects which are the subject of the investigations, and that, as regards the latter, all the precautions to protect the health and safety of the patient.

3. The manufacturer shall also undertake to keep at the disposal of the competent authorities:

3.1 As regards custom-made products, the documentation indicating the place or places of manufacture and allowing for the understanding of the design, manufacture and performance of the product, including the intended performance of the product a way that your compliance with the requirements of this royal decree can be assessed.

The manufacturer shall take all necessary steps to ensure that the manufacturing process ensures conformity of the products manufactured with the documentation referred to in the first paragraph.

3.2 For products intended for clinical research, the documentation shall include:

a general description of the product; and its intended purpose;

design drawings, intended manufacturing methods, especially in the field of sterilization, and schemes of components, subassemblies, circuits, etc.;

the descriptions and explanations necessary for the understanding of the drawings and schemes mentioned and the operation of the product;

the results of the risk analysis, as well as a list of the standards referred to in Article 6, applied in whole or in part, and a description of the solutions adopted to meet the essential requirements of the present provision, where the rules referred to in Article 6 are not applied;

if the product contains, as an integral part, a substance or a substance derived from human blood as referred to in point 7.4 of Annex I, the data relating to the tests carried out in this respect and which are necessary to assess the safety, quality and usefulness of that substance, or substance derived from human blood, taking into account the intended purpose of the product;

if animal tissues of animal origin have been used in accordance with Directive 2003 /32/EC, the risk management measures that have been applied in this context to reduce the risk of infection;

the results of the design calculations, the controls and the technical tests performed, etc.

The manufacturer shall take all necessary steps to ensure that the manufacturing process ensures conformity of the products manufactured with the documentation referred to in the first paragraph of this paragraph.

The manufacturer shall authorise the assessment or, where appropriate, verification of the effectiveness of these measures.

4. The information given in the declarations referred to in this Annex shall be kept for a period of at least five years. In the case of implantable products, the period shall be at least 15 years.

5. As far as the products concerned are concerned, the manufacturer shall undertake to review and document the experience acquired with the products in the post-production phase, including the provisions referred to in Annex X, and use the appropriate means to implement the necessary corrective measures. The undertaking shall include the obligation, on the part of the manufacturer, to inform the competent authorities of the following facts as soon as they are aware of them, as well as the corrective measures that they take:

i. Any malfunction or alteration of the characteristics or performance, as well as any inadequacy of the labelling or instructions for use of a product which may give rise to or may have resulted in death or to the serious deterioration of a patient's or a user's health.

ii. Any technical or health reason related to the characteristics or performance of a product which, for the reasons mentioned in point (i), has induced the manufacturer to carry out a systematic action on products of the same type.

ANNEX IX

Classification Criteria

I. Definitions

1. Definitions in relation to the classification rules.

1.1 Duration.

Passenger Use: Normally used for continuous use for less than sixty minutes.

Short-term use: Typically intended for continuous use over a period of up to thirty days.

Prolonged use: Typically intended for continuous use over a period of more than thirty days.

1.2 Invasive products.

Invasive product: A product that penetrates partially or completely inside the body either through a body hole or through the body surface.

Body orifice: Any natural opening of the body, as well as the outer surface of the eyeball, or an artificial opening permanently created, such as a stoma.

Surgical-type invasive product: An invasive product that penetrates the inside of the body through the body surface by surgical intervention or in the context of a surgical intervention.

For the purposes of this royal decree, products other than those referred to in the preceding paragraph and whose penetration does not occur through one of the recognized body orifices shall be considered to be invasive products of surgical type.

Implantable product.

Any product designed:

to be fully implanted in the human body, or

to replace an epithelial surface or the ocular surface.

By surgical intervention and intended to remain there after intervention.

Any product intended to be partially introduced into the human body by surgical intervention and to remain there after that intervention for a period of time shall also be considered an implantable product. less than thirty days.

1.3 Reusable surgical instrument-Instrument for surgical purposes for cutting, drilling, sawing, scaring, scraping, pinching, retracting, trimming or other similar procedures, without being connected to any product active healthcare, and can be reused once all relevant procedures have been performed.

1.4 Active health product. -Any medical device whose functioning depends on a source of electrical energy or any source of energy other than that generated directly by the human body or by gravity; and to act by conversion of such energy. Medical devices intended to transmit, without any significant modification, energy, substances or other elements of an active medical device to the patient shall not be considered as active medical devices. Standalone software is considered an active healthcare product.

1.5 Therapeutic active product. -Any active medical device used alone or in combination with other medical devices, intended to sustain, modify, replace or restore biological functions or structures in the context of treatment or relief of a disease, injury or deficiency.

1.6 Active Product for Diagnosis. -Any active medical device used alone or in combination with other medical devices, intended to provide information for detection, diagnosis, control or treatment of physiological states, states of health, diseases or congenital malformations.

1.7 Central circulatory system. -In the framework of this royal decree, the following vessels will be understood by central circulatory

:

Pulmonary arteries, ascending aorta, aortic cayate, descending aorta to aortic bifurcation, coronary arteries, primitive carotid artery, external carotid artery, internal carotid artery, cerebral arteries, trunk brachiocephalic, coronary veins, pulmonary veins, superior vena cava, inferior vena cava.

1.8 Central nervous system. -In the framework of this royal decree, the "central nervous system" means the brain, the meninges and the spinal cord.

II. Development standards

2. Development standards.

2.1 The application of the classification rules will be governed by the intended purpose of the products.

2.2 If a product is intended for use in combination with another product, the classification rules apply to each product separately. Accessories shall be classified on their own, separately from the product with which they are used.

2.3 Computer media that serve to handle a product or have influence on its use will automatically be included in the same category.

2.4 If a product is not intended to be used exclusively or primarily in a specific part of the body, its most critical use shall be considered for classification.

2.5 If multiple rules apply to the same product, taking into account the capabilities attributed to you by the manufacturer, the rules that lead to the highest classification apply.

2.6 For the calculation of the duration referred to in point 1.1 of Title I, continuous use of the product for the intended purpose shall be understood by continuous use. However, where the use of a product is interrupted to replace it immediately with the same product or an identical product, this shall be considered an extension of the continuous use of the product.

III. Classification

1. Non-invasive products.

1.1 Rule 1. -All non-invasive products will be included in Class I, unless any of the following rules apply.

1.2 Rule 2. -All non-invasive products intended for the conduction or storage of blood, fluids or body tissues, liquids or gases for an infusion, administration or introduction into the body will enter the class IIa:

If they can connect to an active health product in class IIa or higher class.

If they are intended to be used for the storage or channeling of blood or other fluids or for the storage of organs, parts of organs or body tissues.

All other cases will be included in class I.

1.3 Rule 3. -All non-invasive products intended to modify the biological or chemical composition of the blood, other bodily fluids or other liquids intended to be introduced into the body shall be included in class IIb, unless the treatment consists of filtration, centrifugation or exchange of gases or heat, in which case they shall be included in Class IIa.

1.4 Rule 4. -All non-invasive products that come into contact with injured skin:

They shall be classified in Class I if they are intended to be used as a mechanical barrier, for compression or for the absorption of exudates.

They shall be classified in Class IIb if they are primarily intended for use with wounds that have resulted in a breakdown of the dermis and can only be healed by second intention.

They shall be included in Class IIa in all other cases, including products intended primarily for action in the microenvironment of a wound.

2. Invasive products.

2.1 Rule 5-All invasive products in relation to body orifices, except for invasive surgical products, which are not intended to be connected to or intended for an active medical device be connected to an active health product in Class I:

They shall be included in Class I if they are intended for a passenger use.

To be included in class IIa if they are intended for short-term use, except if used in the oral cavity up to the pharynx, in the external ear canal to the eardrum or in a nasal cavity, in which case they will be included in the class I.

To be included in class IIb if they are intended for prolonged use, except if used in the oral cavity up to the pharynx, in the external ear canal to the eardrum or in a nasal cavity, and cannot be absorbed by the mucous membrane, in which case they shall be included in Class IIa.

All invasive products in relation to body orifices, except for invasive surgical products, intended to be connected to an active medical device of Class IIa or higher class, shall enter in class IIa.

2.2 Rule 6. -All invasive surgical-type products intended for passenger use shall enter Class IIa except that:

Are specifically intended to control, diagnose, monitor, or correct a cardiac or central circulatory system by direct contact with these parts of the body, in which case they will be included in class III.

Be reusable surgical instruments, in which case they will be included in class I.

Are intended to be used specifically in direct contact with the central nervous system, in which case they will be included in class III.

They are intended to supply energy in the form of ionising radiation, in which case they shall be included in class IIb.

They are intended to have a biological effect or to be fully or in large part absorbed, in which case they will be included in class IIb.

They are intended for the administration of medicinal products by means of a supply system, if this is done in a potentially dangerous manner taking into account the mode of application, in which case they will be included in class IIb.

2.3 Rule 7. -All invasive surgical-type products intended for short-term use shall be included in Class IIa unless they are intended to:

Specifically, monitor, diagnose, monitor, or correct a cardiac or central circulatory system by direct contact with these parts of the body, in which case they will be included in class III; or

Use, specifically, in direct contact with the central nervous system, in which case they will be included in class III; or

Supply energy in the form of ionising radiations, in which case they will be included in class IIb; or

Exercise a biological effect or be absorbed, fully or in large part, in which case they will be included in class III; or

Experience chemical modifications in the body, except if the products are placed inside the teeth, or administer medications, in which case they will be included in class IIb.

2.4 Rule 8. -All implantable products and long-term surgical products of a surgical type shall be included in class IIb unless they are intended:

To be placed inside the teeth, in which case they will be included in Class IIa.

To be used in direct contact with the heart, central circulatory system, or central nervous system, in which case they will be included in class III.

To have a biological effect or be fully absorbed or in large part, in which case they will be included in class III.

To undergo chemical modifications in the body, except if the products are placed inside the teeth, or to the administration of medications, in which case they will be included in class III.

3. Additional rules applicable to active products.

3.1 Rule 9.-All active therapeutic products intended for the administration or exchange of energy shall be included in Class IIa unless their characteristics are such that they can administer energy to the human body or exchange it with the same potentially dangerous form, taking into account the nature, the density and the point of application of the energy, in which case they shall be included in class IIb.

All active products intended to control the operation of the active therapeutic products of class IIb or intended to directly influence the operation of such products shall be included in class IIb.

3.2 Rule 10. -All active products for diagnostic purposes will be included in class IIa:

If they are intended to supply energy that is to be absorbed by the human body, excluding products whose function is the illumination of the patient's organism in the visible spectrum.

If they are intended to create an image of the in vivo distribution of radioactive drugs.

If they are intended to permit a direct diagnosis or the monitoring of vital physiological processes unless they are specifically intended for the monitoring of vital physiological parameters, when the variations of these parameters, For example, variations in cardiac function, respiration, CNS activity may present an immediate danger to the life of the patient, in which case they will be included in class IIb.

Active products intended to emit ionising radiation and which are intended for radiology for diagnostic and therapeutic purposes, including products for the control or monitoring of such products, or which directly influence in the operation of the same, shall be included in Class IIb.

Rule 11.-All active products intended to administer, or extract from, medicinal products, body fluids or other substances to the body shall be included in Class IIa, unless this is done in a manner potentially dangerous, taking into account the nature of the substances, the part of the body concerned and the mode of application, in which case they shall be included in Class IIb.

3.3 Rule 12. -All other active products will be included in class I.

4. Special rules.

4.1 Rule 13-All products incorporating as an integral part a substance which, if used independently, could be considered as a medicinal product as defined in Article 1 of the Directive 2001 /83/EC, and which may exercise on the human body an action incidental to that of the products, shall be included in Class III.

All products that incorporate, as an integral part of it, a substance derived from human blood, shall be included in class III.

4.2 Rule 14.-All products used for contraception or for the prevention of the transmission of communicable diseases by sexual contact shall be considered as products of class IIb unless they are products Long-term implantable or invasive, in which case they shall be included in Class III.

4.3 Rule 15. -All products specifically intended for use of disinfection, cleaning, rinsing or, where appropriate, hydration of contact lenses, shall be included in Class IIb.

All products specifically intended for the disinfection of medical devices shall be included in Class IIa, unless they are specifically intended for the disinfection of invasive products, in which case they shall be include in class IIb.

This rule shall not apply to products intended for the cleaning of medical devices other than contact lenses by physical action.

4.4 Rule 16. Products intended specifically for the recording of diagnostic radiographic images shall be included in Class IIa.

4.5 Rule 17.-All products manufactured using animal tissues or derived thereof which have been processed into infeasible shall be included in Class III, except in cases where the products are intended for come into contact only with intact skin.

5. Rule 18. Notwithstanding other rules, blood bags shall be included in class IIb.

ANNEX X

Clinical Assessment

1. General provisions.

1.1 As a general rule, confirmation of compliance with the requirements relating to the characteristics and benefits referred to in paragraphs 1 and 3 of Annex I under normal conditions of use of a product, as well as the assessment of the side effects and the acceptability of the risk-benefit ratio referred to in Annex I, paragraph 6, shall be based on clinical data. The assessment of this data, hereinafter referred to as ‹clinical assessment ›, taking into account, where appropriate, the relevant harmonised standards, shall follow a defined and methodologically appropriate procedure based on:

1.1.1 Well in a critical evaluation of the relevant scientific publications available at that time on the security, performance, design characteristics and intended purpose of the product, when:

this demonstrated the equivalence of the product to the product to which the data refers, and

the data adequately demonstrate compliance with the relevant essential requirements.

1.1.2 Well in a critical evaluation of the results of all the clinical investigations conducted.

1.1.3 Well in a critical assessment of the combination of clinical data provided in 1.1.1 and 1.1.2.

1.1 bis. In the case of implantable products and class III products, clinical investigations shall be carried out unless it is duly justified to rely on existing clinical data.

1.1 ter. The clinical evaluation and its results should be documented. This documentation and/or its full references shall be included in the technical documentation of the product.

1.1 quater. The clinical evaluation and its documentation will be actively updated with data obtained from the post-marketing monitoring plan. Where post-marketing clinical monitoring in the framework of the post-marketing monitoring plan is not deemed necessary, this should be duly justified and documented.

1.1 quinquies. Where the demonstration of compliance with the essential requirements on the basis of clinical data is not deemed necessary, any exclusion in this regard shall be adequately justified on the basis of the results of the risk management and taking into account the specificities of the interaction between the product and the body, the intended clinical performance and the manufacturer's claims. The adequacy of the demonstration of compliance with the essential requirements based on the assessment of the performance, testing on test benches and the pre-clinical assessment shall be duly justified.

1.2 All data shall be considered confidential in accordance with the provisions of Article 7.

2. Clinical investigations.

2.1 Objectives. -The objectives of the clinical research will be:

verify that, under normal conditions of use, the performance of the products is in conformity with those referred to in paragraph 3 of Annex I; and

determine possible undesirable side effects under normal conditions of use and assess whether these are risks in relation to the performance attributed to the product.

2.2 Ethical considerations.-Clinical research will be carried out in accordance with the Helsinki Declaration, adopted in 1964 by the 18th World Medical Assembly in Helsinki (Finland), as last amended by the World medical assembly. It is imperative that the spirit of the Declaration of Helsinki be applied to all the provisions on the protection of persons, and this in each of the stages of clinical research, from the first reflection on the need and the justification for the study until the publication of the results.

2.3 Methods.

2.3.1 Clinical investigations will be carried out according to an appropriate test plan and corresponding to the state of the science and the technique of the moment, defined in such a way as to confirm or refute the claims of the manufacturer for the purpose of the product; these investigations shall include a sufficient number of observations to ensure the scientific validity of the findings.

2.3.2 The procedures used to perform the investigations will be adapted to the product under review.

2.3.3 Clinical investigations shall be carried out under conditions similar to the normal conditions of use of the product.

2.3.4 All relevant features, including those related to safety, product performance and patient effects, shall be examined.

2.3.5 They shall be fully registered and shall be communicated immediately to all the competent authorities of the Member States where the clinical investigation is taking place all serious adverse events.

2.3.6 Investigations shall be carried out in an appropriate environment under the responsibility of a physician or other person possessing the qualifications and authorised for that purpose.

The doctor or authorized person shall have access to the technical and clinical data relating to the product.

2.3.7 The written report, signed by the physician or the responsible person responsible, will contain a critical evaluation of all data obtained during clinical investigations.

3. Samples.

(a) Samples of medical devices to be used in clinical investigations shall be provided free of charge by the sponsor. In certain situations other forms of supply may be authorised.

All leftover samples will be returned to the developer, after the investigation is complete.

(b) The labels and instructions for the instructions for use in clinical investigations should be written in the official Spanish language of the State and allow at any time the perfect identification of products.

(c) The promoter shall keep in the main archive of the test the manufacturing and control protocols for the batch of products manufactured for clinical research.

d) Hospital Pharmacy Services will monitor the supply of the samples to be used in clinical research.

ANNEX XI

Minimum criteria to be observed for the designation of notified bodies

1. The notified body, its director and the staff responsible for carrying out the assessment and verification operations may not be the designer, the manufacturer, the supplier, the installer or the user of the products they control, or the representative of none of these persons. They may not intervene directly or as representatives in the design, construction, marketing or maintenance of these products. This does not preclude the possibility of exchange of technical information between the manufacturer and the body.

2. The body and the staff responsible for monitoring shall carry out the assessment and verification operations with the utmost professional integrity and with the required competence in the health products sector and must be free of all pressure and incitement, in particular economic order, which may influence their judgment or the results of the control, in particular the pressures from persons or groups of persons interested in the results of the verifications.

When a notified body confides specific work to a subcontractor in relation to the observation and verification of facts, it must first ensure that the subcontractor complies with the provisions of the royal decree. and, in particular, this Annex. The notified body shall have at the disposal of the national authorities the relevant documents relating to the assessment of the competence of the subcontractor and the work carried out by the subcontractor in the field of this royal decree.

3. The notified body shall be capable of carrying out all the tasks assigned in one of the Annexes II to VI to the bodies of this type and for which it has been notified, irrespective of whether the tasks are carried out by the body. your own body or under your responsibility. In particular, it will have to have the staff and the necessary means to adequately fulfil the technical and administrative tasks linked to the implementation of the evaluations and verifications. This presupposes the availability of sufficient scientific staff within the organisation, which has the appropriate expertise and knowledge to assess, from a medical point of view, the functionality and performance of the products which have been notified to it, in relation to the requirements of this royal decree, and in particular with the requirements of Annex I. It shall also have access to the equipment to carry out the required verifications.

4. The staff responsible for the checks must have:

Good vocational training for all the assessment and verification operations for which the body has been designated.

A satisfactory knowledge of the requirements regarding the inspections carried out and a sufficient practice of such controls.

The aptitude required to draw up the certificates, minutes and reports that constitute the materialization of the controls performed.

5. The independence of the staff responsible for monitoring must be ensured. The remuneration of each staff member shall not depend on the number of checks carried out or on the result of such checks.

6. The body must take out civil liability insurance, unless such liability is covered by the State Administration, or the controls are carried out directly by public bodies.

7. The staff of the body responsible for checks shall be bound by the obligation of professional secrecy in relation to all that is known to them in the performance of their duties (except in relation to the competent administrative authorities of the Spanish State) in the field of this royal decree or any provision of internal law adopted pursuant to it.

ANNEX XII

CE conformity marking

The CE conformity marking shall consist of the initials "CE" presented in the following form:

If the marking is reduced or wide, the proportions indicated in the graduated scheme shown above must be maintained.

The different components of the CE marking must basically have the same vertical dimension, which cannot be less than 5 millimetres.

This minimum dimension requirement may not be met for small product cases.

ANNEX XIII

Risk analysis and risk management strategy for health products in whose manufacture animal tissues are used

1. Risk analysis and management.

1.1. Justification for the use of tissues or derivatives of animal origin.-Based on their risk analysis and overall risk management strategy for a given health product, the manufacturer shall justify the decision to use the tissues or derived from animal origin referred to in Article 5 (3) (specifying animal species and tissues), taking into account the expected clinical benefit, the potential residual risk and the appropriate alternatives.

1.2. Procedure for evaluation.-In order to ensure a high level of protection for patients or users, the manufacturer of products for which the manufacture of tissues or derivatives of animal origin referred to in paragraph 1.1 shall be used shall carry out an appropriate and well documented risk analysis and risk management strategy in order to address all relevant aspects related to TSEs. It shall also identify the hazards associated with such tissues or derivatives, draw up documentation on the measures taken to minimise the risk of transmission and demonstrate the acceptability of the residual risk associated with the product. the manufacture of which uses such fabrics or derivatives, taking into account the use to which the product is intended and the advantages it provides.

The safety of a product, in terms of its potential for propagating a transmissible agent, depends on all the factors described in paragraphs 1.2.1 to 1.2.7, which should be analysed, assessed and managed. The combination of such measures determines product safety.

Two key stages should be considered, namely:

The selection of the starting materials (tissues or derivatives) considered appropriate in accordance with their potential contamination with communicable agents (see paragraphs 1.2.1, 1.2.2 and 1.2.3), taking into account the Subsequent treatments.

The application of a production process to remove or inactivate transmissible agents present in the tissues or derivatives controlled at source (see section 1.2.4).

In addition, account shall be taken of the characteristics of the product and the use to which the product is intended (see paragraphs 1.2.5, 1.2.6 and 1.2.7).

In the case of risk analysis and the implementation of the risk management strategy, due attention should be paid to the opinions of the relevant scientific committees and, where appropriate, to the opinions of the Committee for Proprietary Medicinal Products whose references have been published in the Official Journal of the European Union.

1.2.1 Animals as a source of material. The risk of TSEs is related to species and breeds, as well as to the nature of the tissue. Given that the accumulation of TSE infectiousness occurs in an incubation period of several years, the supply from healthy young animals is considered to be a risk reduction factor. Risk animals, such as those found dead, who have been killed in emergency situations and those suspected of suffering from TSEs, should be excluded.

1.2.2 Geographical origin.-Waiting for the classification of countries according to their health status in relation to BSE, as provided for in Regulation (EC) No. Regulation of the European Parliament and of the Council of 22 May 2001 laying down provisions for the prevention, control and eradication of certain transmissible spongiform encephalopathies published in the Official Journal of the European Communities The European Union of 31 May 2001, when assessing the risk of a country of origin, the geographical risk of BSE shall be used. The geographical risk of BSE is a qualitative indicator of the likelihood of one or more bovine animals being infected by BSE, both at the pre-clinical and clinical level, at any given time in a given country. Where such presence is confirmed, the geographical risk of BSE provides an indication of the level of infection as specified in the table below:

	level BSE geographic	Presence of one or more infected cattle,
I	I	I
II	Izq"> Improbable, but not
III	Likely, but unconfirmed or committed at a lower level
IV	Confirmed to a higher level

Some factors influence the geographical risk of BSE infection related to the use of raw or derived tissues from a particular country. These factors are defined in Article 2.3.13.2 (1) of the International Animal Health Code of the OIE (International Office of Epizootics), available on the website www.oie.int/esp/normes/mcode/E_00067.htm.

The Scientific Steering Committee has assessed the geographical BSE risk of several third countries and Member States and will continue to do so with all countries that have applied for their health status in relation to BSE, The main factors of the OIE account.

1.2.3 Nature of the starting fabric. The manufacturer shall take into account the classification of the risks related to the different types of starting tissues. The identification of the origin of the animal tissue shall be subject to the control and individual inspection by a veterinarian and the animal carcass shall be certified as fit for human consumption.

The manufacturer shall ensure that there is no risk of cross-contamination at the time of slaughter.

The manufacturer shall not use tissues or derivatives of animal origin considered to be of high potential for TSE infectiousness, unless their use is necessary in exceptional circumstances, i.e. benefit to the patient and no alternative starting tissues.

In addition, the provisions of Regulation (EC) No. 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down health rules for animal by-products not intended for human consumption.

1.2.3.1 Owines and goats.-A classification of infectiousness has been developed for sheep and goat tissues based on current knowledge, on transmissible agents in organic tissues and liquids of sheep and goats. Naturally infected goats by the clinical scrapie. The opinion of the Scientific Steering Committee adopted at the meeting of 22 and 23 July 1999 and entitled 'The policy of breeding and genotyping of sheep' (available on the Commission's website) http://europa http://europa. eu.int/comm/food/fs/sc/ssc/outcome_en.html) includes, in its annex, a table which would later be updated in the opinion TSE infectivity distribution in rough tissues (state of knowledge, December 2001) " (TSE distribution of infective capacity in the ruminant tissues) adopted at the meeting of 10 and 11 January 2002 (available on the Commission's website http://europa). eu.int/comm/food/fs/sc/ssc/outcome_en.html).

The classification may be revised in the light of new scientific evidence (for example, using relevant opinions from the Scientific Committees, the Committee for Proprietary Medicinal Products, as well as measures from the European Commission). regulate the use of material at risk of TSEs.) An analysis of the references to relevant documents or opinions will be published in the Official Journal of the European Union and a list will be established once the European Commission has taken a decision.

1.2.3.2 Bovinos. -The list of specified risk material in Regulation (EC) No. 999/2001 shall be considered as a high potential for TSE infectiousness.

1.2.4 Inactivation or removal of communicable agents.

1.2.4.1 With regard to products that cannot resist a process of inactivation or elimination without suffering an unacceptable degradation, the manufacturer will mainly rely on the control of the origin.

1.2.4.2 For the rest of the products, if the manufacturer declares that the manufacturing processes are capable of removing or inactivating communicable agents, it must be demonstrated by the appropriate documentation.

Relevant information from an appropriate research and analysis of the scientific literature may be used to justify the inactivation or elimination factors when the specific processes mentioned in the bibliography is comparable to those used for the product. Research and analysis should also take into account the possible scientific advice available from an EU Scientific Committee. Such opinions shall serve as a reference in the event of divergent positions.

When the literature investigation does not serve to demonstrate the stated, the manufacturer shall carry out a specific scientific study on inactivation or disposal, taking into account the following:

The identified risk relative to the tissue.

The identification of the relevant model agents.

The justification for choosing specific combinations of model agents.

The identification of the chosen phase to remove or inactivate the communicable agents.

The calculation of the reduction factors.

A final report will identify the manufacturing parameters and limits that are critical to the effectiveness of the inactivation or removal process.

Appropriate documented procedures will be applied to ensure compliance with validated parameters during routine manufacturing.

1.2.5 Quantities of tissues or derivatives of animal origin necessary for the manufacture of a unit of the medical device. The manufacturer shall assess the quantity of tissue in the raw state or derived from animal origin necessary to manufacture a single unit of the medical device. In the case of a purification process, the manufacturer shall assess whether the manufacturer may concentrate the levels of transmissible agents present in the tissues of departure or derived from animal origin.

1.2.6 Tissue or animal-derived products that come into contact with patients and users. The manufacturer must take into account:

i. The amount of tissue or derived from animal origin.

ii. The contact zone: its surface, type (skin, mucous, brain, etc.), and state (healthy or damaged, for example).

iii. The type of tissue or derivative that comes into contact with the patient or user.

iv. The time the product is intended to remain in contact with the body (including the reabsorption effect).

The quantity of the healthcare product that can be used in a given procedure will be taken into account.

1.2.7 Administration path.-The manufacturer will take into account the recommended route of administration in the product information, from the highest risk to the lowest.

1.3 Review of the assessment.-The manufacturer shall establish and maintain a systematic procedure to review the information obtained on its medical device or other similar products in the post-manufacturing phase.

Information will be evaluated to determine its possible safety relevance, namely:

a) If previously unrecognized risks are detected.

b) If the estimated risk arising from a particular hazard is no longer acceptable.

c) If the original evaluation has been invalidated for other reasons.

In case of one of the above situations, the results of the evaluation in the risk management process should be taken into account.

In view of this new information, an analysis of the risk management measures for the product (including the justification for the choice of a tissue or derived from animal origin) shall be provided. If there is a possibility that the residual risk or its acceptability may have changed, it will need to be re-evaluated and justified on the basis of the risk control measures previously applied.

The results of this evaluation should be documented.

2. Assessment of class III medical devices by the notified bodies. -As regards products belonging to Class III in accordance with Rule 17 (all medical devices for the manufacture of which are used) tissues or derived products of animal origin which have been processed into unviable products, except for products intended to come into contact with intact skin only) of Annex IX to this royal decree, manufacturers shall provide the notified bodies with all the relevant information enabling the assessment of the strategy for analysis and management of risks they are applying. Any new TSE risk information collected by the manufacturer and which has an interest for its products must be sent to the notified body for information.

Any changes in relation to the processes of supply, collection, processing and inactivation or disposal that may modify the results contained in the manufacturer's risk management file shall be submitted to the notified body for the purpose of further approval prior to its implementation.