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 634/1993 of 3 May on active implantable 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 active implants. This regulation incorporated into our internal law Council Directive 90 /385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to the active implantable medical devices, which constitutes a specific Directive within the meaning of Article 1 (4) of 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 the electromagnetic compatibility.

The aforementioned royal decree has been subject to various modifications in order to update it in line with the experience gained during its application, as well as to incorporate the new regulations. the consequences of Community provisions.

With this royal decree it is intended to incorporate in a single text all the modifications made to date in order to facilitate the application of the norm, as well as to introduce the last modifications established to the Community level, by means of the transposition of 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 Member States on active implantable medical devices; Directive 93 /42/EEC of the European Parliament Council of 14 June 1993 on medical devices and Directive 98 /8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market.

Similarly, certain aspects of other recent Community provisions are introduced which are considered relevant to the sector, in particular those relating to the obligations of economic operators and controls in the field of Border of 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 Council Regulation (EEC) No 339/93 and Decision No 768 /2008/EC of the European Parliament European and Council of 9 July 2008 on a common framework for the marketing of products and repealing Council Decision 93 /465/EEC.

Active implantable medical devices constitute a type of medical device whose two fundamental characteristics consist, on the one hand, of being intended to be fully or partially introduced into the human body. to remain implanted in it, and on the other hand, that its operation depends on the electricity or any other source of energy other than that generated by the human body or by gravity.

The objectives pursued by the legislation of these products are to ensure their free movement within the Community, while at the same time offering a high level of protection, so that products that circulate do not risks to the health or safety of patients, users or third parties, and achieve the assigned functioning when they are implanted in the human body and used under the conditions laid down.

In order to achieve these objectives, the essential requirements for the products, including those related to software that incorporate the products or to help their operation and those of particular application to products containing derivatives of human blood. Compliance with these requirements is facilitated by reference to harmonised European standards.

The conformity assessment procedures to be applied by manufacturers with a view to affixing the CE marking to their products are also laid down. These procedures are carried out by the notified bodies designated by the national authorities, who have the capacity to supervise the activities of these bodies, and should provide them with all the information necessary, including those relating to certificates issued, rejected, suspended or withdrawn. The standard details the procedure to be followed by the notified body in its conformity certification activities requested by the manufacturers.

Clinical research is one of the crucial stages in the development of new implants or new applications, which is why the conditions under which these investigations should be carried out are detailed. and the information to be maintained, provided or recorded in the relevant files and databases.

The obligations of manufacturers, users and others responsible for the communication of adverse incidents to the health authorities, as well as the operation of the Product Surveillance System, are also detailed. health protection by which such incidents are received and assessed and the health protection measures intended to prevent their repetition or to reduce their consequences are transmitted. For the purpose of strengthening health guarantees, the requirement for an implementation card to facilitate the adoption of measures on patients is established, if necessary.

A special group of products are the products as they are intended to be used by a particular patient who has certain characteristics. For these products, the standard also provides for the 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 products. once placed on the market.

According to the provisions of Article 100 of Law 14/1986, of 25 April, General of Health, the manufacture, grouping and sterilization of the products, as well as their import, indicating 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 Decision No 768 /2008/EC, the obligations of the economic operators involved in the chain of placing on the market of products: manufacturers, importers and distributors, in relation to the preservation and maintenance of the relevant documentation at the disposal of the authorities for a period of 15 years, the adoption of measures corrective to any suspicion or evidence of health risks or to the lack of conformity of the the products, subject to the decisions of the health authorities and of cooperation and cooperation with them, as well as traceability intended for the monitoring 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.

The conditions for the external trade of the products are established, specifying the requirements to be applied by the sanitary inspection in the import of the products. The information is also determined to provide the health authorities with information on the products at the time of their making available on Spanish territory, as well as the information on the Spanish companies responsible for placing on the market.

The distribution, sale and advertising are regulated, which are generally reserved for health professionals or health centers, establishing a ban on the sale of active implantable medical devices to the public. by telematic means, all in accordance with the provisions laid down in this field by Law 29/2006 of 26 July as a safeguard against the general interest in the protection of public health.

In turn, 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.

By means of this royal decree, Royal Decree 634/1993 of 3 May on active implantable medical devices is repealed.

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 health In addition to the general principles and coordination of health care, guaranteeing, as regards the processing of personal data, compliance with the Organic Law 15/1999 of 13 December on the 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 prior deliberation of the Council of Ministers, at its meeting on 23 October 2009,

DISPONGO:

CHAPTER I

General provisions

Article 1. Object.

This royal decree aims to regulate active implantable medical devices, 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.

For the purposes of this royal decree, it is understood by:

(a) "Health product" means any instrument, device, equipment, software, material or other article, used alone or in combination, together with any accessories, including software intended for use by its manufacturer for specific purposes of diagnosis and/or therapy and which is involved in its 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) "Active health product" means any health product that is dependent on electricity or any other source of energy other than that generated directly by the human body or by gravity, to function appropriately.

(c) "active implantable medical device" means any active medical device intended to be placed in whole or in part, by surgical or medical intervention, in the human body, or by medical intervention, in a natural orifice, and intended to remain after such intervention.

(d) "bespoke product" means any product specifically manufactured in accordance with the written prescription of a specialist practitioner, in which he/she bears the specific design characteristics under his/her responsibility; is intended to be used only by a particular patient. Products manufactured according to continuous or serial manufacturing methods requiring adaptation to meet specific needs of the physician or other professional user shall not be considered as a tailor-made product.

(e) "Product for clinical research" means any product intended to be made available to an optional specialist to carry out the clinical investigations referred to in Annex 7.2.1 carried out in a appropriate human clinical environment.

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

g) "Put into service": The provision of optional staff for deployment.

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

(i) "Manufacturer" means the natural or legal person responsible for the design, manufacture, packaging and labelling of an active implantable medical device, with a view to placing on the market of such an active implantable medical device; whether these operations are carried out by the same person or by a third party on behalf of that person.

The obligations to which manufacturers are subject by virtue of this royal decree shall also apply to the natural or legal person who assembles, condition, treats, wholly renews and/or assigns them a purpose as a product with (i) the Commission's proposal for a decision on the implementation of the common market. 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.

(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, in accordance with this provision.

k) "Clinical data": Security and/or performance information derived from the use of a product. Clinical data are obtained from:

1. The clinical investigation of the product in question; or

2. th 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. the 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) "specialist faculty" means a physician 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.

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

n) "Distributor": Any natural or legal person in the supply chain other than the manufacturer or importer who markets a product.

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

or) "Promoter": Manufacturer, authorized representative or other individual or organization who assumes responsibility for the initiation and/or implementation of a clinical investigation.

Article 3. Scope and exclusions.

1. This royal decree will apply to:

a) Active implantable healthcare products.

b) The conditions for the use of implantable medical devices active in clinical investigations.

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 (a) to (e).

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 (a) to (e), submit a duly justified request to the European Commission to take the necessary measures.

3. Where an active implantable 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 guarantees and rational use of medicinal products and medical devices, and provisions that develop it.

4. Where an active implantable medical device incorporates as an integral part a substance which, used separately, can be considered as a medicinal product, as defined in Article 2.1 of Royal Decree 1345/2007 of 11 October 2007, regulating the procedure for the authorization, registration and conditions for the supply of medicinal products for human use manufactured industrially, and which may exercise in the body an action incidental to that of the product, said product shall be evaluated and shall authorise in accordance with this provision.

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 of the Royal Decree 1345/2007 of 11 October 2007 and which may exercise in the body an action ancillary to that of the product, hereinafter referred to as 'the substance derived from human blood', that product shall be assessed and authorised in accordance with the provisions of this royal decree.

6. The active implantable 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, which regulates the compatibility of the electromagnetic of electrical and electronic equipment.

7. This royal decree will not apply to:

a) The drugs. 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.

(b) 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.

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

(d) Organs, tissues or cells of animal origin, except in cases where a product has been made from animal tissues which have been processed into unviable or unviable tissue products animals.

Article 4. Health guarantees for active implantable medical devices.

1. Active implantable medical devices can only be placed on the market and/or put into service if they meet the requirements set out in this royal decree when they have been properly supplied, properly installed and maintained, and used in accordance with their 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 paragraphs 14 and 15 of Annex 1, at least in Spanish, in order to provide for a certain and objective form of information effective, truthful and sufficient about its essential characteristics.

3. Only active implantable medical devices which 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 intended purpose of the manufacturer.

4. 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 active implantable medical device that you receive in the course of your treatment. This shall be without prejudice to the provisions of Article 29 on the requirement for implementing cards.

Article 5. Essential requirements.

1. The active implantable medical devices referred to in Article 2 (c), (d) and (e), hereinafter referred to as 'the products', shall comply with the essential requirements set out in Annex 1 which are applicable to them taking into account its 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 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 1 to this Royal decree.

Article 6. Presumption of conformity with the essential requirements.

1. Where active implantable 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 in particular shall be considered, for the purposes of the preceding paragraph, in particular to the interaction between medicinal products and materials used as containers of medicinal products, the references of which have been published in the Official Journal of the European Union.

Article 7. Confidentiality.

1. Without prejudice to existing provisions on professional secrecy, the health authorities shall ensure that all the 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 in accordance with Article 14;

(b) the 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 28;

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 active implantable medical devices.

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

3. The Spanish Agency for Medicines and Health Products and the Autonomous Communities will also 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 Health, natural or legal persons engaged in the manufacture, import, grouping or sterilisation of active implantable medical devices and the facilities for such activities shall require prior operating licence, granted by the Spanish Agency for Medicinal Products and Sanitary 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. The Spanish Agency for Medicinal Products and Sanitary Products shall grant a single prior operating licence 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 Medicinal Products and Sanitary Products shall request the functional areas of health of the Government Delegations to report on the conditions under which undertakings are to carry out the activities referred to in paragraph 1, by ordering the inspections 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.

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 22.

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

Conformity Marking

Article 11. CE conformity marking.

1. Only active implantable medical devices 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 12.

2. The CE conformity marking, which is reproduced in Annex 9, must be affixed to the packaging of the product which ensures sterility, visibly, legibly and indelibly; it shall also be placed on the outer packaging, if any, and on the package leaflet.

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 2, 4 or 5, as appropriate.

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

5. The CE conformity marking may not be affixed, as provided for in this royal decree, in products which do not comply with the definition laid down in Article 2 (c).

6. 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.

7. 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 12. Conditions for affixing the CE marking.

1. The manufacturer shall, for the purposes of affixing the CE marking, opt for any of the following conformity assessment procedures:

(a) EC declaration of conformity, set out in Annex 2, or

(b) EC type examination, as set out in Annex 3, in combination with one of the following procedures:

1. EC Verification, set out in Annex 4, or

2. EC declaration of conformity with type, as set out in Annex 5.

2. The manufacturer may instruct his authorised representative in the European Union to initiate the conformity assessment procedures set out in Annexes 3, 4 and 6. Both the manufacturer and his representative in the course of such procedures are subject to the obligations laid down in the relevant Annexes.

3. Where the Spanish Agency for Medicinal Products and Sanitary Products considers that the conformity of a product or family of products is to be established, by way of derogation from paragraph 1, by applying only one of the 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 13. Express authorizations.

The Spanish Agency for Medicines and Health Products may expressly and individually authorize the placing on the market and putting into service of products for which it is not necessary, in the interests of health protection. the conformity assessment procedures referred to in Article 12 have been satisfied.

CHAPTER IV

Products with a special purpose

Article 14. Tailor-made products.

1. Products as measured shall not be provided with the CE marking or the communication provided for in Article 19 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 6 and made the necessary declaration of conformity before placing on the market, and

(b) are accompanied by the declaration of conformity provided for in that Annex, which must be at the disposal of the particular patient to whom the product is intended.

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 putting into service in Spain products shall be made available to the competent authorities for a period of at least 15 years from the date of manufacture of the last product, the products which it has put into service in Spain, together with a copy of the declaration set out in paragraph 2 of Annex 6 and the documentation set out in paragraph 3 of this Annex.

4. Manufacturers established in Spain placing products on the market will make a communication to the Spanish Agency for Medicines and Health Products to be included in the Register of Responsible for the placing on the market where the description of his registered office and the products in question is recorded. This obligation shall be extended to the authorised representative when established in Spain.

5. 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 marketing of the products shall also be communicated.

6. The Spanish Agency for Medicinal Products and Sanitary Products shall inform the European Commission and the other Member States of the data provided by the manufacturer or authorised representative referred to in paragraph 1. 4.

Article 15. Products intended for clinical investigations.

1. Products intended for clinical research shall not be provided with the CE marking or the communication provided for in Article 19 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 6 and has established the necessary declaration of conformity, and

(b) the investigation complies with the provisions of Articles 26 and 27.

3. The manufacturer of a product intended for clinical investigations or his authorised representative shall have at the disposal of the competent authorities, for a period of 15 years, the declaration referred to in paragraph 2 of Annex 6 and the documentation of paragraph 3 of that Annex, as well as the report referred to in paragraph 2.3.7 of Annex 7.

CHAPTER V

Notified body

Article 16. Notified bodies.

1. The Ministry of Health and Social Policy shall designate the bodies which shall carry out the procedures referred to in Article 12 and the specific tasks assigned to each body and shall notify the European Commission and the other States of the members. Such designation shall be published in the "Official State Gazette", together 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 designate them and verify the maintenance of these skills in the designated bodies.

2. Notified bodies shall comply with the requirements set out in Annex 8. Bodies meeting the criteria laid down in the national rules transposing the relevant harmonised standards 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 minimum requirements listed in Annex 8, the Ministry of Health and Social Policy shall withdraw the designation, subject to the procedure with a hearing of the person concerned, it shall inform the European Commission and the other Member States thereof.

Article 17. 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 manufacturers of medical devices. active implantable.

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, if justified, require any data or information it deems necessary to establish or maintain the certificate of conformity in the light of the chosen procedure.

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 Regulation. royal decree, in an intermediate stage of manufacture.

4. Decisions taken by the notified body in accordance with Annexes 2, 3 and 5 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. the manufacturer's request and the notified body's agreement.

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, subject to restrictions, or withdraw the certificate issued, taking into account 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 8.

Article 18. 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, shall follow the following procedure:

1. The procedure shall be initiated at the request of the manufacturer or his authorised representative, as referred to in Article 12 (1) and (2). 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, having reviewed the arguments, shall communicate the final decision to the person concerned in the 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 pursuant to Articles 116 and 117 of Law No 30/1992 of 26 November 1992 on the Legal Regime of Public Administrations and the Administrative Procedure. Common.

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 17 (6

.

CHAPTER VI

Marketing and commissioning

Article 19. Marketing and commissioning communication and traceability records.

1. Any natural or legal person who, for the first time, makes available an active implantable medical device for distribution and/or use on Spanish territory, must direct a communication to the Spanish Medicines Agency and Medical devices at the time when such making is made available.

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 active implantable medical devices on the market shall maintain a documented record of the products that it makes available on Spanish territory containing at least the data following:

a) Commercial name of the product.

b) Model.

c) Serial number or batch number.

d) Date of shipment or supply.

e) Customer identification.

Article 20. Content of the communication.

1. The communication will contain the following data:

a) Identification data of the person making the communication.

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

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) Description and intended purpose of the product.

(e) Identification data of the manufacturer and the place of manufacture and of his authorised representative in the European Union, where appropriate.

(f) 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.

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

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

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

j) Identification data of distributors in Spain, in case 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 19. Any changes to the certificates, including their suspension or withdrawal, as well as the cessation of marketing, shall also be communicated.

Article 21. Information to the Autonomous Communities.

The Spanish Agency for Medicines and Health Products shall provide access to the records provided for in Article 14 and Article 19, to the competent health authorities of the Autonomous Communities.

Article 22. 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 control purposes for a period of 15 years from the date of manufacture of the last product.

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 situation, under the conditions laid down by the health authorities, immediately, in the case of a product in which the CE marking is not included in this case 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, placing on the market 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 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 15 years from the date of manufacture or supply of the last product.

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 28, 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 23. Distribution and sale.

1. Only products which comply with this royal decree and which are not expired may be the subject of distribution and sale, taking as a reference for the latter the date referred to in the last indent of paragraph 14.1 of the Annex. 1.

2. The distribution and sale of the products when carried out by operators other than the manufacturer or importer established in Spanish territory shall be carried out in establishments which guarantee their proper storage and storage, and the supervision of a responsible technician whose certification provides an adequate qualification, which shall be directly responsible for the performance of the activities and obligations laid down in Article 19. It will also be responsible for the technical-health information on the products it distributes or put into service in Spain.

3. The distribution and sales establishments shall be subject to the supervision and inspection of the health authorities of the autonomous community concerned.

4. Natural or legal persons engaged in such activities shall carry out a prior notification of initiation of activity to the health authorities of the Autonomous Community, which shall contain:

a) Identification of the establishment and its activity.

b) Types of products that you distribute or sell.

c) Identification and qualification of the technician.

5. The distribution establishments shall have the right organisation and means to take any appropriate measures in the event 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:

a) Commercial name of the product.

b) Model.

c) Serial number.

d) Date of shipment or supply.

e) Customer identification.

6. Active implantable medical devices shall be sold exclusively to healthcare professionals or healthcare facilities.

CHAPTER VII

Intra and external trade

Article 24. Community circulation and import.

1. Products introduced from Community countries and those 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 Medicinal Products and Sanitary Products, through the inspection services of the functional areas of health of the Government Delegations, will verify that in the imports of active implantable medical devices meet 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 25. Export.

Products that are manufactured for export to non-Community countries and do not comply with the requirements set out in this provision 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 26. Clinical investigations.

1. In carrying out clinical investigations with active implantable medical devices, the ethical, methodological and protection principles of the test subjects, referred to in Royal Decree 223/2004 of 6 February, will be applied. clinical trials with medicinal products are regulated, as well as in Annex 7 of this royal decree.

Where clinical investigations are carried out with products bearing the CE marking, Article 27 shall not apply to them unless such investigations are intended to use the products in a an indication different from that referred to in the relevant conformity assessment procedure. The corresponding provisions of Annex 7 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 this research has the favourable opinion of the Ethical Committee for Clinical Research referred to in Article 60 of Law 29/2006, of 26 July. The compliance 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 kept at the disposal of 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 7 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 27. 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 6. 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 centre where the clinical investigation is carried out; the investigation is to be performed.

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 from your request will result in the expiry of the procedure and the file of the proceedings, unless, within that period, the Spanish Medicines Agency and Medical devices have authorised, on a reasoned request from the applicant, an extension of that period.

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

CHAPTER IX

Surveillance System

Article 28. Surveillance system.

1. Manufacturers or, failing this, 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 a product, as well as any inadequacy of the labelling or instructions for use which may give rise to or may have been result in the 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 Medicines and Health Products shall inform the manufacturer of the product concerned or its authorised representative.

The health centres shall appoint 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 29. 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 record in a centralised manner the notifications, taking, where appropriate, the necessary measures for the protection of health, as set out in Article 31.

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, which may be prevented or modified for justified reasons of public health.

Article 29. Implementation card.

1. Active implantable medical devices that are distributed in Spain must be accompanied by an implementation card. This card will not be required for the "software" required for the operation of the products.

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 30. 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 complied with.

The violation of the provisions of this royal decree will result in the adoption by these authorities of the precise corrective measures, regardless of the penalties they will take.

2. The Spanish Agency for Medicinal Products and Health Products, by itself or through the inspection services of the functional areas of health of the Government Delegations, may carry out inspection and control activities in respect of the products of foreign trade and of establishments in which they are manufactured, imported or exported, provided that they are situated in national territory, and in the other cases provided for in Article 98 (2) of Law 29/2006, of 26 July.

3. Personnel serving the Public Administrations that will carry out the inspection functions shall proceed as set out in Article 98.3 of Law 29/2006 of 26 July, and may also request any information necessary to verify compliance with the provisions of this royal decree for products placed on the market in Spain and subject to clinical research.

4. 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 31. Health protection measures.

1. The Spanish Agency for Medicinal Products and Sanitary Products and other competent health authorities, where they consider that an active implantable medical device, a tailor-made product or a group of certain products, once put into service and being used correctly in accordance with its intended purpose, may compromise the health and/or safety of patients, users or third persons, shall proceed to adopt the appropriate precautionary measures provided for in the article 26 of Law 14/1986 of 25 April and 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 does not appear, contrary to the provisions of this royal decree, the Spanish Agency for Medicinal Products and Sanitary Products and the other the competent health authorities shall take appropriate measures 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 body by the authority that adopted the measure. 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 32. 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 may include the necessary warnings to avoid health risks in use. of the products.

The measures taken pursuant to this Article shall apply to them as provided for in Article 31 (5).

Article 33. 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 Articles 114 and Law 30/1992, of 26 November.

CHAPTER XI

Advertising and exhibitions

Article 34. Advertising and promotion of products.

1. The advertising and promotion of the products covered by this provision shall be governed by the general principles laid down in Law 34/1988 of 11 November, General Advertising, and Articles 27 and 102 of Law 14/1986 of 25 April, General of Health and Law 29/2006 of 26 July, of guarantees and rational use of medicines and medical devices.

2. Direct or indirect publicity directed to the public of the products referred to in this royal decree may not be carried out.

3. The means of information and promotion used as support, whether written, audiovisual or otherwise, shall be basically scientific in character and shall be aimed and distributed exclusively 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. In particular, the texts of information or promotion shall indicate the conformity of the product with the legislation, as well as the contraindications and possible side effects that may arise from the use of the products.

5. The advertising, information or promotion of any product which, without complying with the provisions of this royal decree, intends to carry out any of the purposes referred to in point (c) of Article 2 shall be prohibited.

Article 35. Incentives.

In accordance with Article 3 (6) of Law 29/2006 of 26 July, in the framework of the promotion of active implantable medical devices, it is prohibited to grant, offer or promise premiums. pecuniary or benefits in kind to healthcare professionals who prescribe the products, as well as 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 36. 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 active implantable medical devices, apply exclusively to activities of a scientific nature where the recipients are the medical 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 37. 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 38. Violations.

Will have the consideration of violations of 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, and in Article 101 of Law 29/2006, of 26 in July, on the guarantees and rational use of medicinal products and medical devices, and specifically the following:

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. The failure to comply with the communication duty of the amendments relating to the information provided for in Article 20 of this royal decree.

3. Failure to comply with requirements relating to advertising and product promotion texts.

2. Serious breaches:

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

2. The use of any other marking that may lead to confusion in the CE marking.

3. 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.

4. The conduct of clinical investigations without complying with the procedures and conditions provided for in this royal decree.

5. The non-compliance with the placing on market and/or in service communication duty.

6. Failure to comply with the obligation to maintain the documented record provided for in Article 23 of this royal decree.

7. The failure of the duty to provide documentation set out in Article 22 of this royal decree.

8. Failure to comply with distribution and sales conditions.

9. The breach of the notification duty provided for in Article 28 of this royal decree.

10. The violation of the principle of confidentiality.

11. The putting into service in Spain of active implantable medical devices that do not include the mandatory data at least in Spanish.

3. Very serious breaches:

1. The placing on the market and/or in service of products that compromise the safety or health of patients, users or third parties.

2. The improper use of CE marking.

3. The carrying out of clinical investigations without complying with the content of the protocols communicated, or without respecting the obligations relating to 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.

4. The failure to comply with the obligation to implement the measures relating to Article 22 of this royal decree.

5. The incorrect execution, by the notified body, of the actions entrusted to it in Article 17 of this royal decree.

6. Failure to comply with the precautionary measures taken by the competent health authorities.

Article 39. Penalties.

1. The actions and omissions constituting infringements, as provided for in Article 38 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 38 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.

Additional disposition first. Application of fees.

The procedures laid down in Articles 9, 12, 19 and 26 of this Royal Decree shall apply to them the corresponding fees set out in Group VIII of Article 111.1 of Law 29/2006 of 26 July 2006. guarantees and rational use of medicinal products and medical devices.

Additional provision second. 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 cities with Statute of Autonomy of Ceuta and Melilla, within the framework of their competences.

Additional provision third. 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 shall make available to interested parties the standard models and the information on the procedures.

Single transient arrangement. Validity of the authorisation, certification and communication procedures.

The authorisation, certification and communication procedures carried out under Royal Decree 634/1993 of 3 May on active implantable medical devices 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 634/1993 of 3 May on active implantable medical devices.

Final disposition first. 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 second. 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 relating to active implantable medical devices; Council Directive 93 /42/EEC of 14 June 1993 on medical devices and Directive 98 /8/EC of the European Parliament and of the Council the Council of 16 February 1998 concerning the placing of biocidal products on the market.

Final disposition third. 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.

Final disposition fourth. Entry into force.

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

Given in Madrid, on October 26, 2009.

JOHN CARLOS R.

The Minister of Health and Social Policy,

TRINIDAD JIMENEZ GARCIA-HERRERA

ANNEX 1

Essential Requirements

I. General requirements

1. The products must be designed and constructed in such a way that their use does not compromise the clinical condition or the safety of patients when they are put in place under the conditions and for the intended purposes.

They must not present any risks to persons who implanting them or, where appropriate, to third parties.

2. The products shall provide the services assigned to them by the manufacturer, that is to say, designed and manufactured in such a way as to enable them to perform one or more of the functions referred to in Article 2 (a), and such as the manufacturer has specified them.

3. The general requirements referred to in paragraphs 1 and 2 shall not be altered to such a degree as to be committed to the clinical status and safety of patients and, where appropriate, third parties, for the duration of the period of validity provided for by the manufacturer for the products, and even if the product is subject to the limit situations resulting from the normal conditions of use.

4. Products must be designed, manufactured and conditioned in such a way that their characteristics and performance are not altered by the storage and transport conditions provided by the manufacturer (temperature, humidity, etc.).

5. Any undesirable side effects should be acceptable risks in relation to the benefits attributed.

5 bis. The demonstration of compliance with the essential requirements should include a clinical assessment in accordance with Annex 7.

II. Requirements relating to design and manufacturing

6. The solutions adopted by the manufacturer as regards the design and manufacture of the products shall comply with the principles of security integration, taking into account the generally recognised state of the art.

7. Implantable products must be designed, manufactured and packaged in non-reusable packaging in accordance with appropriate procedures to ensure that they are sterile at the time of placing on the market and under the conditions of storage and transport provided by the manufacturer maintain this quality until the packaging is opened with a view to its implementation.

8. The products must be designed and manufactured in such a way as to be removed or reduced as far as possible:

The risks of injuries linked to their physical characteristics or dimensions.

The risks associated with the use of energy sources, in the case of electricity, particular attention to insulation, leakage currents and heating of products.

The risks associated with the reasonably foreseeable environment conditions, in particular those linked to magnetic fields, external electrical influences, electrostatic discharges, pressure or pressure variations, acceleration, etc.

The risks associated with medical interventions, particularly those derived from the use of defibrillators or high-frequency surgical equipment.

The risks related to the ionizing radiation of radioactive substances included in the product, in compliance with the protection requirements laid down in Council Directive 96 /29/Euratom of 13 May 1996, laying down the basic rules for the protection of the health of workers and the public against the risks arising from ionising radiation and in Council Directive 97 /43/Euratom of 30 June 1997, on the protection of health from the risks arising from ionising radiation in medical exposures.

The risks arising from the lack of maintenance and calibration related especially to:

a) The excessive increase in leakage currents.

b) The degradation of the materials used.

c) The excessive increase in heat generated by the product.

d) Deterioration of the accuracy of any measurement or control mechanism.

9. The products must be designed and manufactured in such a way as to ensure the characteristics and performance referred to in point I 'General requirements'. It will be particularly attended to:

The choice of materials used, especially as regards toxicity.

The reciprocal compatibility between the materials used and the tissues, biological cells and body fluids, taking into account the intended use of the product.

The compatibility with the substances that they are intended to administer.

The quality of connections, particularly in the security plane.

The reliability of the power source.

Where appropriate, the proper tightness.

The smooth operation of command, programming and control systems, including software. For products incorporating software or medical software, such software must be validated in accordance with the current state of the art, taking into account the principles of development of the business cycle. life, risk management, validation and verification.

10. Where a product incorporates, as an integral part, a substance which, if used separately, can be regarded as a medicinal product within the meaning of Article 2.1 Royal Decree 1345/2007 of 11 October 2007 regulating the the procedure for the authorization, registration and conditions for the supply of medicinal products for human use manufactured industrially, and which may exercise in the body an act of access to that of the product, the quality, safety and usefulness of such a substance they shall be verified by analogy with the methods set out in Annex I to that royal decree.

For the substances referred to in the previous paragraph, the notified body, after 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 through its committee, in accordance with Regulation (EC) No 726/2004 of the European Parliament and of the Council Council Directive of 31 March 2004 laying down Community procedures for the authorisation and control of medicinal products for human and veterinary use and establishing the European Medicines Agency, a scientific opinion on the quality and safety of such a 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 in accordance with the requirements of the notified body.

When a product incorporates as an integral part a substance derived from human blood, the notified body, having verified the usefulness of the substance as part of the medical device and taking into account the purpose In order to ensure that the substance of the substance concerned is not included in the Directive, the Commission shall, acting in particular by its committee, request the EMEA to provide 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 in accordance with the requirements of 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, as established by the notified body, in order to ensure that the changes do not adversely affect the substance of the substance. benefit-risk ratio 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 obtained information on the ancillary substance which may have an impact on the risk-benefit ratio established for the addition of the substance in the product, it shall indicate to the notified body whether or not that information has an effect on the risk-benefit ratio established for the addition of the substance in the product. The notified body shall take into account the updated scientific opinion when reviewing its conformity assessment procedure.

11. The products and, where appropriate, their constituents must be identified in such a way as to enable any appropriate action to be taken that is necessary due to the discovery of potential risks arising from the products and their components.

12. The products must bear a code allowing the product to be clearly identified (in particular the type of product and the year of manufacture) and the manufacturer and the code must be detectable, where appropriate, without the need for a surgical intervention.

13. Where a product or its accessories carry instructions necessary for the operation of the product or indicate operating or adjustment parameters by means of a display system, such information shall be comprehensible to the user and, if applicable, the patient.

14. Each product must be legibly and indelibly present, where appropriate by generally recognised symbols, the following indications:

14.1 On packaging that ensures sterility:

The sterilization method.

Indications to allow this packaging to be recognized.

The name and address of the manufacturer.

The product description.

If this is a product for clinical research, the mention "exclusively for clinical research".

If this is a custom product, the mention "tailored product".

The indication that the implantable product is in a sterile state.

Timestamp of the month and year of manufacture.

The indication of the deadline by which the product can be safely implanted.

14.2 On Commercial Packaging:

The name and address of the manufacturer and the name and address of the authorised representative when the manufacturer has no registered office in the Community.

The product description.

The destination of the product.

The particular features required for proper use.

If this is a product for clinical research, the mention "exclusively for clinical research".

If this is a custom product, the mention "tailored product".

The indication that the implantable product is in a sterile state.

Timestamp of the month and year of manufacture.

The indication of the deadline by which the product can be safely implanted.

The transport and storage conditions of the product.

In the case of one of the medical devices referred to in Article 3 (5), an indication that the medical device contains a substance derived from human blood.

15. At the time of placing on the market each product must be accompanied by an instruction package containing the following elements:

The year of CE marking placement authorization.

The indications referred to in points 14.1 and 14.2, with the exception of those set out in the eighth and ninth indents.

The benefits referred to in point 2 as well as any unwanted side effects.

The necessary information to allow the physician to select the appropriate product as well as the software and the appropriate accessories.

The information which constitutes the mode of use and which allows the doctor and, where appropriate, the patient to use the product correctly, its accessories and the software, as well as the information relating to nature, the scope and time limits of the checks and tests and, where appropriate, the maintenance measures.

The information that is useful in your case to avoid certain risks arising from the implementation of the product.

Information on the risks of reciprocal interference (negative influences on the medical device caused by instruments present during investigations, treatments and vice versa), linked to the presence of product in specific research or treatment.

The instructions required in the event of a breakdown of the packaging which ensures sterility and, where appropriate, the indication of suitable resterilization methods.

The warning, if applicable, that a product may only be used again in case it has been reconditioned under the manufacturer's responsibility to meet the essential requirements.

The package leaflet must also include indications that allow the physician to inform the patient about the contraindications and precautions to be observed. These indications shall be particularly relevant to:

Information to define the life span of the power source.

The precautions to be taken in case of changes in product performance

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

The appropriate information regarding the medications that the health product is intended to administer.

Publish date of the latest revision of the usage instructions.

16. Confirmation of compliance with the requirements relating to the characteristics and performance of the product referred to in point I. General requirements, under normal conditions of use, as well as the assessment of side effects Undesirable effects shall be based on clinical data established in accordance with the provisions of Annex 7.

ANNEX 2

EC Declaration of Compliance

(Full Quality Assurance System)

1. The manufacturer shall apply the approved quality system for the design, manufacture and final inspection of the medical devices concerned, as provided for in paragraphs 3 and 4 of this Annex, and shall be subject to the EC control, as provided for in paragraph 5 of this Annex.

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

The manufacturer or his representative shall affix, in accordance with Article 11, the CE marking and extend a declaration of conformity.

The declaration shall refer to one or more clearly identified products by the product name, product code or other unambiguous reference, and the manufacturer shall retain it.

The CE marking shall be accompanied by the identification number of the notified body responsible.

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:

All relevant information for the category of products to be manufactured.

The documentation for the quality system.

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

A commitment to the maintenance of the approved quality system, in order to ensure its adequacy and effectiveness.

A commitment on the part of the manufacturer to establish and maintain an after-sales monitoring system that includes the provisions mentioned in Annex 7. The undertaking shall include the obligation on the part of the manufacturer to inform the competent authorities of the following facts immediately after they have become aware of them:

i. Any malfunction or alteration of the characteristics or performance of a product, as well as any inadequacy of the labelling or instructions for use 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 linked to the characteristics or performance of a product which, for the reasons mentioned in the preceding paragraph, has induced the manufacturer to carry out a systematic action on the products of that product type.

3.2 The application of the quality system must ensure the conformity of the products with the provisions of this royal decree applicable to all phases, from the design to the final controls.

All the elements, requirements and provisions adopted by the manufacturer for its quality system shall appear 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 quality policy and procedures such as quality programmes, plans, manuals and quality records. It shall include in particular the documents, data and records resulting 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, and in particular:

Of the organizational structures, the responsibilities of the technicians and their organizational authority in terms of quality of design and the manufacture of the products.

Of the means to control the effective functioning of the quality system, and in particular its ability to obtain the desired quality of design and products, including the control of non-compliant products.

Of 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 performs the design, manufactures and/or carries out the final inspection and testing of the products or their components.

c) Procedures for controlling and verifying the design of products, and in particular:

Of the design characteristics, including the rules to be applied and the descriptions of the solutions adopted to meet the essential requirements that apply to the products when the standards referred to in Article 8 shall not apply in full.

Of the techniques of control and verification of the design, procedures and systematic actions to be used in the design phase of the products.

A statement indicating whether or not the product contains, as an integral part, a substance or a substance derived from human blood as referred to in paragraph 10 of Annex 1, as well as 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,

The preclinical assessment,

The clinical assessment referred to in Annex 7.

d) Of the quality assurance and control techniques in the manufacture and in particular:

Of the processes and procedures used, in particular, in the field of sterilization, procurement and relevant documents.

Of the product identification procedures adopted and updated on the basis of drawings, specifications and other relevant documents throughout all manufacturing phases.

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

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.

The assessment team shall include at least one member who has experience in evaluations within the technological field concerned. The assessment procedure shall include an inspection of the manufacturer's premises and, in duly justified cases, of the facilities of the manufacturer's suppliers and/or subcontractors, to inspect the procedures of the manufacturer. manufacturing.

The decision will be notified to the manufacturer after the last visit. It 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 project to modify the system.

The notified body shall evaluate the proposed amendments and check whether the quality system thus amended meets the requirements referred to in paragraph 3.2, notifying 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 an application for a study of the design dossier for the product to be manufactured and which is part of the category

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 to enable it to judge its conformity with the requirements of this royal decree, in particular those of points (c) and (d) of point 3.2 of Annex 2.

This request must contain, in particular:

The design features, including the rules that have been applied.

A mandatory test showing its suitability, especially where the standards referred to in Article 8 have not been fully applied. Such test shall include the results of the appropriate tests, carried out by the manufacturer or under his responsibility.

The indication that the product incorporates or does not, as an integral part, a substance as referred to in Annex 1 (I0), the action of which in combination with the product may lead to its availability by the body, as well as the data relating to the tests carried out in this respect.

The clinical assessment referred to in Annex 7.

The instructions package leaflet.

4.3 The notified body shall examine the application and, if the product complies with the requirements of this Royal Decree which apply to it, it shall issue an EC design examination certificate to the applicant. The notified body may require the application to be completed with additional tests, so that compliance with the requirements of this Royal Decree can be assessed. This 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 destination of the product.

In the case of the products referred to in the second subparagraph of Annex 1 (10), 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 the products referred to in the third subparagraph of Annex 1 (10), 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 scientific opinion of the EMEA is unfavourable. Communicate to the EMEA its final decision;

4.4 The applicant shall inform the notified body that it has issued the EC design examination certificate on any modification that has been introduced in the approved design. The modifications introduced shall be accompanied by an additional approval by the notified body which has issued the EC design examination certificate where such modifications may affect conformity with the requirements the essential requirements for the use of the product, as provided for in the royal decree. Such additional approval shall be granted in the form of an annex 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 quality system documentation.

The data provided for in the part of the quality system relating to the design, for example the results of the analyses, the calculations, the tests, the preclinical and clinical evaluation, the post-marketing clinical monitoring plan, the results of this follow-up, if applicable, etc.

The data provided for in the part of the quality system relating to manufacturing, such as the reports for inspections, tests, contracts and 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 By the notified body, inspections may also be carried out through unannounced visits to the manufacturer, to which a report on the manufacturer will be delivered.

6. Administrative provisions.

6.1 For a minimum period of 15 years from the date of manufacture of the last product, the manufacturer or his authorised representative shall have at the disposal of the national authorities:

The compliance declaration.

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

The modifications referred to in section 3.4.

The documentation referred to in section 4.2.

The decisions and reports of the notified body referred to in paragraphs 3.4, 4.3, 5.3 and 5.4.

6.2 The notified body shall make available to the other notified bodies and the competent authority, at their request, all relevant information concerning approvals of quality systems issued, rejected or withdrawn.

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 this batch of products and transmit the official certificate of release to the for 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 Article 114 (2) of the Directive 2001 /83/EC.

ANNEX 3

EC type examination

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

2. The manufacturer, or his authorised representative, shall submit the application for the EC type-examination to a notified body.

This request must include:

The name and address of the manufacturer, as well as the name and address of your authorized representative in case the application is present.

A written declaration specifying that the request has not been submitted to another notified body.

The documentation referred to in paragraph 3 of this Annex, which is necessary to assess the conformity of the representative sample of the intended production, hereinafter referred to as the 'model', in accordance with the requirements of this Annex royal decree.

The applicant shall make a model available to the notified body. The notified body may request other copies if necessary.

3. The documentation shall enable the design, manufacture and performance of the product to be understood. The documentation 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 descriptions of the solutions adopted to meet the essential requirements when these standards are not applied.

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

The statement indicating whether or not the product contains, as an integral part, a substance or a substance derived from human blood referred to in paragraph 10, Annex 1, as well as the data relating to the tests carried out on the as regards the safety, quality and usefulness of the substance or substance derived from human blood, taking into account the intended purpose of the product,

The preclinical assessment,

The clinical assessment referred to in Annex 7,

The instructions package leaflet.

4. The notified body.

4.1 Examining and evaluating the documentation shall verify that the type has been manufactured in accordance with the documentation; it shall also indicate the elements that have been designed in accordance with the applicable provisions of the above mentioned standards. 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 carry out the appropriate tests and tests necessary to verify that the solutions adopted by the manufacturer meet the essential requirements of this royal decree, when the rules are not applied referred to in Article 6.

4.3 It shall carry out or make appropriate checks and tests to check whether, in the event that 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 assessment, the conditions of validity of the certificate and the data necessary for the identification of the approved model.

The relevant parts of the documentation shall be attached to the certificate; the notified body shall keep a copy of it.

In the case of the products referred to in Annex 1 (10), the notified body shall, as regards the aspects referred to in that paragraph, consult one of the competent authorities designated by the Member States. Member States shall take into account the requirements of 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 the products referred to in Annex 1 (10), 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 scientific opinion of the EMEA is unfavourable. It will communicate to the EMEA its final decision.

6. The applicant shall inform the notified body which has issued the EC type-examination certificate of any changes to the approved product.

When the modifications made to the approved product may affect their conformity with the essential requirements or 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 new approval shall be issued, where appropriate, in the form of an Annex to the initial EC type-examination certificate.

7. Administrative provisions.

7.1 Each notified body shall make available to the other notified bodies and to the competent authority, at their request, all relevant information relating to the EC type-examination certificates and the Granted, rejected or withdrawn.

7.2 The other notified bodies may obtain a copy of the EC type-examination certificates or their amendments. The annexes to the certificates shall be made available to the other notified bodies, on a reasoned request, after informing the manufacturer.

7.3 The manufacturer or his representative shall keep, together with the technical documentation, a copy of the EC type-examination certificates and their supplements for a period of at least 15 years from the manufacture of the last product.

ANNEX 4

CE Verification

1. EC verification is the procedure by which the manufacturer or his authorised representative declares and declares that the products complying with the provisions of paragraph 3 are in conformity with the type described in the EC type-certificate and comply with the requirements of the requirements of this provision that apply to you.

2. The manufacturer shall take all 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 relevant requirements of this provision. The manufacturer or his authorised representative shall affix the CE marking to each of the products and extend a written declaration of conformity.

3. The manufacturer shall prepare, before the start of manufacture, a documentation explaining the manufacturing processes, in particular those relating to sterilisation and the set of pre-established and systematic provisions which shall be applied to ensure the homogeneity of the production and conformity of the products with the type described in the EC type-examination certificate and with the relevant requirements of this provision.

4. The manufacturer shall undertake to establish and maintain an updated post-sales monitoring system including the provisions referred to in Annex 7. The obligation of the manufacturer to inform the competent authorities, as soon as he reaches his knowledge, of the following shall be included in this undertaking:

i. Any malfunction or alteration of the characteristics or performance of a product, as well as any inadequacy of the labelling or instructions for use 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 linked to the characteristics or performance of a product which, for the reasons mentioned in the preceding paragraph, has induced the manufacturer to carry out a systematic action on the products of that product type.

5. The notified body shall carry out the appropriate examinations and tests to verify the conformity of the product with the requirements of this provision by inspecting and testing each of the products, taking a statistical sample as is specified in paragraph 6. The manufacturer shall authorise the notified body to assess the effectiveness of the measures taken pursuant to paragraph 3, if necessary, by audit.

6. Statistical verification.

6.1 The manufacturer shall present the products manufactured in homogeneous batches and shall take all necessary measures to ensure that the manufacturing process ensures the homogeneity of the batches produced.

6.2 A sample of each batch will be randomly taken. The products forming part of that sample shall be examined one by one, and the appropriate tests as defined in the relevant rules referred to in Article 6, or equivalent tests, shall be carried out to verify conformity with the type described in the EC type-examination certificate and determine whether the batch is accepted or rejected.

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. Sampling systems shall be determined in accordance with the rules referred to in Article 6, taking into account the specific nature of the product categories concerned.

6.4 In accepted lots, the notified body shall affix or cause its identification number to be placed on each product and shall extend a certificate of conformity concerning the tests carried out. All products in the lot may be placed on the market, except for products whose non-conformity has been demonstrated.

Where a lot is rejected, the competent notified body shall take appropriate measures to prevent the placing on the market of the consignment. Where lots are frequently rejected, the notified body may suspend the statistical verification.

The manufacturer may place during the manufacturing process and under the responsibility of the notified body, the identification number of the notified body.

6.5 The manufacturer or his authorised representative must be able to submit, if requested, the notified body's certificates of conformity.

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 this batch of products and transmit the official certificate of release to the for 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 Article 114 (2) of the Directive 2001 /83/EC.

ANNEX 5

CE declaration of compliance with type

(Production Quality Assurance)

1. The manufacturer shall apply the approved quality system for the manufacture and final control of the products concerned, as specified in paragraph 3, and shall be subject to the control referred to in paragraph 4, both of which are Annex.

2. This declaration of conformity is the procedure whereby the manufacturer who fulfils the obligations of paragraph 1 ensures and declares that the products concerned 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 you.

The manufacturer or his authorised representative shall affix the CE marking in accordance with Article 11 and extend a written declaration of conformity. The manufacturer shall keep this declaration, which shall relate to products manufactured, clearly identified with the name of the product, the product code or other unambiguous reference. The CE marking shall be accompanied by the identification number of the notified body responsible.

3. Quality system.

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

This request must contain:

All relevant information about the products to be manufactured.

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 in a way that ensures its adequacy and effectiveness.

Where applicable, the technical documentation relating to the approved type and a copy of the EC type examination certificate.

A commitment by the manufacturer to establish and maintain an updated post-sales monitoring system including the provisions set out in Annex 7. The commitment shall involve the obligation of the manufacturer to inform the competent authorities of the following facts, as soon as they are aware of them:

iii. Any malfunction or alteration of the characteristics or performance of a product, as well as any inadequacy of the labelling or instructions for use 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.

iv. Any technical or health reason linked to the characteristics or performance of a product which, for the reasons mentioned in the preceding paragraph, has induced the manufacturer to carry out a systematic action on products of the same type.

3.2 The application of the quality system shall 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 appear 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 programmes, plans, manuals and quality 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 responsibility of the cadres and their authority for the organization as regards the manufacture of the products.

Of the means to control the effective functioning of the quality system, and in particular its ability to obtain the desired quality of the 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 a third party in case it is a third party who manufactures and/or carries out the final inspection and the testing 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, above all, sterilization, purchases and relevant documents.

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

(d) The appropriate examinations and tests to be carried out before, during and after production, the frequency with which they will be carried out and the test equipment used.

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 a visit to the manufacturer's premises.

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

3.4 The manufacturer shall communicate to the notified body that the quality system has been approved for any project modification of that system.

The notified body shall evaluate the proposed modifications and check whether the quality system thus amended meets the requirements of paragraph 3.2 of this Annex, the decision shall be notified to the manufacturer. The conclusions of the inspection and a reasoned assessment shall be set out in them.

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 quality system documentation.

The technical documentation.

The data provided for in the part of the quality system relating to manufacturing, such as the reports concerning the inspections, the tests, the contrasts/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 an assessment report to the manufacturer.

4.4 By the notified body, inspections may also be carried out through unannounced visits to the manufacturer, to which a report on the manufacturer will be delivered.

5. The notified body shall communicate to the other notified bodies the relevant information concerning the approvals of the quality systems issued, refused and withdrawn.

6. 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 this batch of products and transmit the official certificate of release to the for 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 Article 114 (2) of the Directive 2001 /83/EC.

ANNEX 6

Statement regarding products with a special purpose

1. The manufacturer or his authorised representative shall draw up the declaration with the elements specified in point 2 of this Annex for the products for use and for products intended for clinical research.

2. The declaration will contain the following data:

2.1 For custom products:

The name and address of the manufacturer

The data required to identify the product in question.

The claim that the product is intended for the exclusive use of a patient indicating its name.

The name of the physician who has made this prescription and, if applicable, name of the affected healthcare facility.

The product-specific characteristics indicated by the prescription.

The claim that the product is in accordance with the essential requirements set out in Annex 1 and, if applicable, an indication of the essential requirements which it does not fully comply with.

2.2 For products intended for clinical research referred to in Annex 7:

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 substance derived from human blood referred to in Annex 1, paragraph 10.

The approval of the conduct of the test by an Ethics Committee of Clinical Research duly accredited, with an indication of the aspects that are the subject of this opinion.

The name of the optional or other person authorised for that purpose and that of the institution responsible for the investigation.

Place, start date and expected duration of the investigation.

A declaration stating that the product concerned complies with the essential requirements, with the exception of the aspects which are the subject of the investigations and which, as far as these aspects are concerned, have been taken precautions necessary to protect the health and safety of the patient.

3. The manufacturer shall undertake to make available to the competent national authorities:

3.1 With regard to tailor-made products, documentation indicating the place or places of manufacture and allowing for the understanding of the design, manufacture and performance of the product, including performance planned, in such a way that their conformity 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 With regard to products intended for clinical investigations, the documentation shall also include:

A general description of the product and its intended purpose.

Drawings of design, methods of manufacture, in particular, in the field of sterilization, as well as schemes of components, subassemblies, circuits, etc.

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

The results of the risk analyses and a list of the standards referred to in Article 6, applied in full or in part, as well as the description of the solutions adopted to meet the essential requirements of this royal decree when these rules are not applied.

If the product contains as an integral part, a substance or a substance derived from human blood referred to in Annex 1, paragraph 10, the data relating to the tests carried out in this respect and which are necessary to evaluate the safety, quality and usefulness of the substance or substance derived from human blood, taking into account the intended purpose of the product.

The results of the design calculations performed, the checks and technical tests performed, and so on.

The manufacturer shall take all necessary measures to ensure that the manufacturing process ensures conformity of the products manufactured with the documentation referred to in paragraph 3.1 and in the first paragraph of this paragraph. paragraph.

The manufacturer may authorise the assessment, where appropriate, by an audit, of the effectiveness of those measures.

4. The information given in the declarations referred to in this Annex shall be kept for a period of not less than 15 years from the date of manufacture of the last product.

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 7, 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 of a product, as well as any inadequacy of the labelling or instructions for use 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 linked to the characteristics or performance of a product which, for the reasons mentioned in the preceding paragraph, has induced the manufacturer to carry out a systematic action on the products of that product type.

ANNEX 7

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 points 1 and 2 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 benefit-risk ratio referred to in point 5 of Annex I shall be based on clinical data. The assessment of this data, hereinafter referred to as a 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:

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 assessment of the results of all the clinical investigations performed;

1.1.3 Well in a critical assessment of the combination of clinical data provided in 1.1.1 and 1.1.2.

1.2 Clinical investigations will be conducted, unless it is duly justified to rely on existing clinical data.

1.3 Clinical evaluation and results should be documented. This documentation and/or its full references shall be included in the technical documentation of the product.

1.4 Clinical evaluation and documentation will be actively updated with data from the post-marketing monitoring plan. Where post-marketing clinical monitoring in the framework of the post-marketing monitoring plan is not deemed necessary, it shall be duly justified and documented.

1.5 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 expected 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.

1.6 All data must be confidential, unless disclosure is deemed indispensable.

2. Clinical research.

2.1 Objectives. -Clinical research objectives will consist of:

Check whether, under normal conditions of use, the performance of the product corresponds to those referred to in paragraph 2 of Annex 1, and

Determine, under normal conditions of employment, the potential unwanted side effects and assess whether these are acceptable risks with respect to the expected benefits of 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 of doctors in Helsinki (Finland), as last amended In 1983, it is imperative that the spirit of the Declaration of Helsinki be applied to all of the world's medical doctors in Tokyo (Japan), in 1975 and the 30th World Assembly of doctors in Venice (Italy). the provisions relating to the protection of persons, and this in each of the stages of the clinical research, from the first reflection on the need and justification of the study to the publication of the results.

2.3 Methods:

2.3.1 Clinical investigations shall be conducted in accordance with an appropriate research plan, corresponding to the state of science and technology, defined in such a way as to confirm or refute the findings of the the manufacturer in respect of the product; such investigations shall include a sufficient number of observations to ensure the scientific validity of the findings.

2.3.2 The procedures used to carry out the investigations must be adapted to the product under examination.

2.3.3 Investigations should be conducted in circumstances equivalent to those that would be under normal product use conditions.

2.3.4 All relevant features, including those relating 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 under the supervision of a duly qualified practitioner or authorised person in a suitable environment.

The responsible practitioner will have access to the product's technical data.

2.3.7 The written report, signed by the facultative responsible, will include a critical judgment of all the information collected throughout the investigations.

3. Samples:

(a) Samples of implantable medical devices active for use 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 shall be returned to the promoter after the test is completed.

(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 8

Minimum requirements to be collected by notified bodies for designation

1. The body, its director and the staff responsible for carrying out the assessment and verification operations shall be persons other than the designer, the manufacturer, the supplier or the installer of the product under control, and different of the authorised representative of any of these parties. They shall not be directly involved in the design, construction, marketing or maintenance of the product or represent any of the parties involved in these activities. This, however, does not exclude the possibility for the manufacturer and the body to exchange technical information.

2. The body and the staff responsible for the control shall carry out the assessment and verification operations with the highest degree of professional integrity and technical competence; they shall not be subjected to any pressure, or it shall provide for no incentive, in particular economic, which may influence its judgment or the results of the inspection, in particular by persons or groups of persons who are interested in the outcome of the verifications.

3. The body must be able to carry out all the tasks set out in one of the Annexes to the second paragraph 5, which have been assigned to it and for which it has been accredited, either the same designated body or the body is carried out under its responsibility. responsibility. In particular, it shall have at its disposal the necessary personnel and possess the necessary means to be able to carry out the technical and administrative tasks relating to the assessment and verification properly; they shall also have access to the equipment that is required for the necessary verifications.

4. The staff responsible for the control must have:

A sound professional training on the set of assessment and verification operations for which the notified body has been designated.

A satisfactory knowledge of the requirements of the controls they carry out and an appropriate experience in such controls.

The aptitude required to write the certificates, record, and reports that are required to authenticate the execution of the controls.

5. The independence of the inspection staff shall be ensured. Their remuneration should not be established according to the number of checks carried out or the results of such checks.

6. The body shall be covered by a liability insurance covering the risks arising from the exercise of the functions provided for in this Royal Decree, 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 shall be obliged to observe the professional secrecy in relation to all the information to which it accesses during the performance of its tasks under this provision, except as regards the Ministry of Health and Social Policy.

ANNEX 9

CE Conformity Marking

The CE conformity marking shall be composed of the initials CE, designed as follows:

If the CE marking size is reduced or increased, the proportions of this logo should be retained.

The different elements of the CE marking must clearly have an appreciably equal vertical dimension, which shall not be less than 5 millimetres.

Exceptions to the minimum dimension are allowed in the case of small-size products.