Law 14/1986, of 25 April, General of Health, attributes to the State Administration, in its Article 40.5 and 6, the regulation, authorization and registration or approval, as appropriate, of those products and articles The health of humans may pose a risk to human health by affecting the human being. Article 110 of the same Law entrusts the State Health Administration to assess the safety, efficacy and efficiency of health and health care technologies.

On the other hand, Law 25/1990 of 20 December of the Medicamento, in its article 1.3, states that, inter alia, the regulation of principles, standards, criteria and basic requirements on efficiency, safety and quality of medical devices, as defined in Article 8 (12) of the Directive, since, as the explanatory statement points out, they must be identical to those which the law seeks for medicinal products. That Law empowers the Government, in its third subparagraph, paragraph 2, to determine those medical devices to be approved, approved or certified by the State, in view of their particular risk or importance for the health.

This Royal Decree develops these Laws, in accordance with the provisions of Council Directive 93 /42/EEC of 14 June 1993 on medical devices, which must offer patients, users and other persons a high level of protection and satisfy the performance assigned to them by the manufacturer. Objectives that are achieved through the fulfilment of certain essential requirements.

Notes that Directive to demonstrate the conformity of medical devices with the essential requirements and to enable conformity control to be carried out is of use the reference to the harmonised standards developed by the European Committee for Standardisation (CEN) and the European Committee for Electronic Standardisation (CENELEC) and, in specific subjects, certain monographs of the European Pharmacopoeia.

Healthcare products are grouped into four classes: I, IIa, IIb and III, the decision rules for classification in the vulnerability of the human body, taking into account the risks arising from the design of the products, their manufacture and their intended destination. Each of these classes is subject to different conformity assessment procedures, as set out in Annexes II to VIII of this provision.

Compliance assessment procedures for Class I products can generally be performed under the sole responsibility of manufacturers, given the low degree of vulnerability associated with these products. In the case of products of Class IIa, the mandatory intervention of a notified body must have as its object the stage of manufacture; whereas, for the products of classes IIb and III which have a high risk potential, imposes a check carried out by a notified body with regard to the design of the products and their manufacture. Class III is reserved for the most critical products, the placing on the market of which requires explicit prior authorisation for conformity.

This provision, together with Royal Decree 634/1993 of 3 May on active implantable medical devices transposing Directive 90 /385/EEC, forms the legislative acquis of medical devices and has been Certain amendments to Directive 90 /385/EEC, by means of Directive 93 /42/EEC and Directive 93 /68/EEC, also apply to the amendment of Royal Decree 634/1993.

Directive 93 /42/EEC covers the products covered by Council Directive 84 /539/EEC of 17 September 1993, which is transposed into our law by Royal Decree 65/1994 on the safety requirements of the apparatus of the Directive The Commission is also concerned about the use of electrical and veterinary medicinal products and the repeal of this Royal Decree as regards the use of such products in human medicine.

This Royal Decree, in whose preparation the sectors affected and the Interterritorial Council of the National Health System have been heard, is dictated by the provisions of Article 149.1.1., 10. and 16. In accordance with Articles 40.5 and 6, 95, 100 and 110 of Law 14/1986 of 25 April, General of Health, and Articles 1.3, 2.1, 2.2, 8.12 and the third and final provision of Law 25/1990, of 20 of 20 December, of the Medication.

In its virtue, on the proposal of the Minister of Health and Consumer Affairs, after approval of the Minister for Public Administrations, in agreement with the Council of State and after deliberation of the Council of Ministers at its meeting of the March 1, 1996,

D I S P O N G O:

CHAPTER I

General provisions

Article 1. Scope of application.

1. This Royal Decree lays down the conditions to be met by medical devices and their accessories, for placing on the market, putting into service and use, and the procedures for assessing conformity to them. application.

The conditions for their use in clinical research are also determined.

The accessories of the medical devices will receive an identical treatment to the latter. Hereinafter referred to as 'products', both medical devices and their accessories.

2. When a medical device is intended to administer a medicinal product, as defined in Article 8.1 of Law 25/1990 of 20 December 1990, of the medicinal product, and the provisions implementing it, the medical device shall be regulated by the present Royal Decree and the medicinal product must comply with the provisions of the legislation on medicinal products.

However, if a product of this kind is marketed in such a way that the product and the medicinal product constitute a single integrated product intended to be used exclusively in such an association and not This product will be governed by the provisions of Law 25/1990 of 20 December of the Medication. As regards the characteristics of the product related to their safety and their performance, the corresponding requirements set out in Article 6 and in Annex I to this Royal Decree shall apply.

3. Where a product incorporates, as an integral part, a substance which, if used separately, can be considered as a medicinal product, and which can exercise in the human body an action ancillary to that of the product, that product must be assessed and be authorised in accordance with the provisions of this Royal Decree.

Article 2. Exclusions.

1. Excluded from this Royal Decree:

a) Products intended for "in vitro" diagnosis.

b) The active implantable products to which Royal Decree 634/1993 applies, of 3 May, as amended by the additional provision sixth of this Royal Decree.

c) The medicinal products covered by Law 25/1990 of 20 December of the Medicamento and provisions that develop it.

d) The cosmetic products regulated by Royal Decree 349/1988 of 15 April and provisions amending it.

e) Human blood, human blood-based products, blood plasma or blood cells of human origin, products which at the time of marketing contain such blood products, plasma or cells blood of human origin.

(f) The organs, tissues or cells of human origin and products incorporating or derived from human tissues or cells.

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

h) Personal protective equipment regulated by Royal Decree 1407/1992 of 20 November.

2. The decision on whether a given product is regulated by Royal Decree 1407/1992 of 20 November 1992 governing the conditions for the marketing and free movement within the Community of individual protective equipment The main purpose of the product shall be taken into account, in particular.

3. This Royal Decree lays down Directive 93 /42/EEC, which is a specific Directive within the meaning of Article 2 (2) of Directive 89 /336/EEC. Consequently, the medical devices whose conformity has been determined in accordance with this Royal Decree do not apply to them Royal Decree 444/1994 of 14 March 1994 laying down the procedures for the assessment of the conformity and protection requirements relating to the electromagnetic compatibility of equipment, systems and installations transposing Directive 89 /336/EEC.

4. This provision does not affect the application of Decree 2869/1972 of 21 July 1972 on the regulation of nuclear and radioactive installations; of Royal Decree 18/1991 of 30 December 1991 on the installation and use of X-ray apparatus for medical diagnosis purposes, and Royal Decree 53/1992 of 24 January, approving the Regulation on Health Protection against Ionising Radiation, which transpose Directives 80/836/EURATOM and 84 /467/EURATOM, as follows: as in the case of Royal Decree 1132/1990 of 14 September 1990 laying down measures the fundamental radiation protection of persons undergoing medical examination and treatment, which is transposed by Directive 84/466/EURATOM.

Article 3. Definitions.

For the purposes of this provision,

following definitions shall apply:

(a) "Health product" means any instrument, device, equipment, material or other article, used alone or in combination, including software which is operated by the manufacturer; to be used in humans for the purpose of:

1. The diagnosis, prevention, control, treatment or alleviation of a disease.

2. The diagnosis, control, treatment, relief or compensation of 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 function can contribute such means.

(b) "Accessories" means an article which, without being a medical device, is specifically intended by the manufacturer to be used in conjunction with a product so that the product can be used in accordance with the purpose intended for the product by its manufacturer. (c) 'in vitro diagnostic' means any product consisting of a reagent, reactive product, assembly, instrument, device or system used alone or in combination, intended by the manufacturer to be used in vitro in the examination of samples from the human body in order to provide data on physiological states, or states of health or disease, or congenital anomalies.

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

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

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

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

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

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

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

i) 'is in service': the stage in which a medical device is ready to be used on the Community market for the first time in accordance with its intended purpose.

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

Article 4. Classification.

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

2. In the event of a dispute between the manufacturer and the notified body on the basis of the application of the classification criteria, the case shall be referred to the Minister for Health and Consumer Affairs.

CHAPTER II

Sanitary guarantees for products

Article 5. General conditions.

1. In accordance with Article 100 of Law 14/1986 of 25 April 1986 on certain activities relating to medical devices, the manufacture, the grouping and the sterilisation of such products on national territory require prior health leave of operation of the facility, granted by the Directorate-General of Pharmacy and Health Products. In the same way, they shall require prior authorization of establishment of premises located in national territory in which the importation of medical devices from third countries is carried out, for the placing on the market or putting into service in the Community territory.

In order to carry out the activities mentioned in the previous paragraph, the companies will have a technical officer, entitled university, whose qualifications accredit a suitable qualification according to the products that is in charge, who shall exercise the direct supervision of such activities.

2. The health products and the health products may be placed on the market and put into service only if, when properly installed and when they are maintained and used in accordance with their intended purpose, they do not compromise safety or health of patients, users and, where appropriate, third parties.

3. At the time of their entry into service in Spain, the products must include the data and information contained in paragraphs 2.7, 5.4 and 7 of Annex I, at least in the official Spanish language of the State, in order to provide for a certain and objective of effective, truthful and sufficient information on its essential characteristics.

4. Products whose labelling or promotional material contains particulars or flags which fail to mislead may not be placed on the market, attribute functions which do not possess or provide expectations of successful success or which, after their indicated or prolonged use, are not no harmful effect will appear. Nor can it be attributed to medical or surgical intervention.

5. Only 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 in accordance with the conditions laid down by the manufacturer.

Article 6. Essential requirements.

1. The products referred to in this Royal Decree must be designed and manufactured in such a way that their use does not compromise the clinical condition, health or safety of patients when used in the conditions and for the purposes of the intended. They shall also not present any risks to persons who use them or, where appropriate, 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 3 (a) or (b), and as the manufacturer has specified them.

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

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

a) Eliminate or reduce risks as far as possible (safety inherent in design and manufacturing).

b) Adopt appropriate protective measures, including alarms, if they are necessary, in the face of risks that cannot be eliminated.

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

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

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

6. The relationship between benefit and risk must be assessed, so that the possible risks and/or unwanted side effects constitute acceptable risks in relation to the benefits attributed and the benefit they provide to the patient. Such benefit/risk balance shall be compatible with a high level of health and safety protection.

7. The products shall meet the essential requirements laid down in Annex I which apply to them, taking into account the destination of the products concerned.

8. Compliance with the requirements set out in paragraphs 1, 2 and 6 of this Article, under normal conditions of use, shall be demonstrated by clinical data obtained in accordance with Annex X to this Regulation. Royal Decree, in particular, in the case of implantable products and class III products.

Article 7. CE conformity marking.

1. Only medical devices bearing the CE marking may be placed on the market and put into service. By way of derogation, the health products to be measured and those intended for clinical investigation shall be governed by Article 9.

The CE marking may be affixed only to products which have demonstrated their conformity with the essential requirements referred to in Article 6 and which have followed the conformity assessment procedures identified in the Article 8.

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

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

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

4. No other marking may be affixed to the product which may give rise to confusion with the 'EC' conformity marking. If the product, its package leaflet or its packaging includes any other mark, the visibility and legibility of the CE marking shall not be reduced.

5. The CE conformity marking may also not be affixed, in accordance with the provisions of this Royal Decree, in products which do not comply with the definitions in Article 3 (a) or (b). In case of detection, such cases shall be treated, for all purposes, as "non-compliant products", the procedures provided for in this Royal Decree being applied.

6. In the case of products to which other Community Directives apply, or national provisions which have transposed them, in respect of other aspects in which the affixing of the CE marking is provided for, only the affixing of the marking marking if the products also comply with the relevant provisions of those other Directives or national provisions.

However, if one or more of those Directives or national provisions transposing them would allow the manufacturer, during a transitional period, to choose which measures to apply, the CE marking shall indicate that the products only comply with the provisions of the national Directives or provisions applied by the manufacturer.

In such a case, the references of those Directives, as published in the Official Journal of the European Communities, must appear in the documents, leaflets or instructions provided by the Directives or national provisions accompany the products. Such documents must be accessible without the packaging being destroyed which, where appropriate, ensures the sterility of the product.

Article 8. Conditions for affixing the CE marking.

1. The manufacturer, for the purposes of affixing the CE marking, shall, in accordance with the class of product concerned, opt for any of the following conformity assessment procedures, which shall be, where appropriate, developed by: any of the notified bodies included in the list to which it is published in the Official Journal of the European Communities.

These procedures will not apply to custom products or products intended for clinical investigations.

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

1. Class III Products:

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

(b) EC type-examination referred to in Annex III, in combination:

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

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

2. Class IIb Products:

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

(b) EC type-examination referred to in Annex III, in combination:

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

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

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

3. Class IIa Products:

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

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

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

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

Instead of applying these procedures, the manufacturer may also follow the procedure referred to in paragraph 1.2 (a

.

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

2. Where the Directorate-General for Pharmacy and Health Products considers that the conformity of a product or a family of products is to be established, by way of derogation from the provisions of the preceding paragraph, Certain procedures, chosen from among those referred to in this Article, shall submit a duly substantiated request to the Commission for the adoption of appropriate measures, to inform the other Member States and to publish in the Official Journal of the European Communities ' the relevant elements of those measures.

Article 9. Products with a special purpose.

1. Products intended for clinical research shall be considered as products for a special purpose for the purposes of this provision, and shall not bear the CE marking and shall not apply to such products. provided for in Article 12.

2. Only products that may be placed on the market and put into service shall be:

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

(b) In the case of a product of classes IIa, IIb or III, it is accompanied by the declaration provided for in Annex VIII.

3. The manufacturer or any person who puts into service in Spain products for a period of five years, shall have at the disposal of the competent authorities the relationship of the products he has put into service in Spain together with a copy of the declaration set out in paragraph 2.1 of Annex VIII and the documentation referred to in paragraph 3.1 of this Annex.

4. 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 manufacturer or authorised representative on the Community territory has followed the procedure referred to in Annex VIII and has established the necessary declaration of conformity, and

(b) The procedure referred to in Article 19 has been followed by the manufacturer or authorised representative on the territory of the Community.

5. The manufacturer of a product for clinical research or his authorised representative shall have at the disposal of the competent authorities, for a period of five years, the declaration referred to in paragraph 2.2 of Annex VIII and the documentation of paragraph 3.2 of that Annex, as well as the report referred to in paragraph 2.3.7 of Annex X.

Article 10. Systems, assemblies and equipment for medical or surgical procedures.

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

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

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

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

2. Where products which do not bear the CE marking or when the combination of the products chosen is not compatible with the original intended use are included in the system, set or equipment for medical or surgical procedures, they shall be treated as a product in their own right and shall be subject to the appropriate procedure laid down in Article 8 of this Royal Decree.

3. Any natural or legal person who sterilizes systems, assemblies or equipment for medical or surgical procedures referred to in the preceding paragraphs for their placing on the market, as well as other medical devices bearing the CE marking and which have been intended by their manufacturers to be sterilised before use, shall be subject to one of the procedures laid down in Annexes IV, V and VI, and shall be limited to aspects relating to the production of sterility. In the same sense, the intervention of the notified body concerned.

This natural or legal person shall make a statement stating that the sterilisation has been carried out in accordance with the manufacturer's instructions.

4. The products referred to in paragraphs 1 and 3 shall be accompanied by the information referred to in paragraph 7 of Annex I to this Royal Decree, including, where appropriate, the information provided by the manufacturers of the products which have been grouped. These products will not bear a new CE marking.

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

5. The grouping and sterilisation activities referred to in this Article are considered to be manufacturing activities within the meaning of Article 5 (1) of this Royal Decree.

Article 11. Presumption of conformity with the essential requirements.

1. Medical devices bearing the CE marking and having followed the conformity assessment procedures referred to in Article 8 shall be deemed to be in conformity with the essential requirements, with the exception of prima facie evidence.

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

3. 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 Communities, respectively.

4. For the purposes of the second paragraph, the monographs of the European Pharmacopoeia relating, inter alia, to surgical sutures and the interaction between medicinal products and materials used as containers of the medicines, the references of which have been published in the Official Journal of the European Communities.

CHAPTER III

Marketing and commissioning

Article 12. Communication of placing on the market and putting into service.

1. Any person who places on the market or puts into service a product of Class III or class IIb shall direct a communication to the Directorate-General for Pharmacy and Health Products at the time when the first marketing of the product is effective. product in Spain.

2. In the case of medical devices which do not come from third countries, the communication may be made in the register setting out, where appropriate, the Autonomous Community in which the first provision of the medical device is made. The Autonomous Community shall immediately forward the documentation to the Directorate-General for Pharmacy and Health Products.

3. Communications may be submitted in any of the places provided for in Article 38 of Law No 30/1992 of 26 November 1992, of the Legal Regime of Public Administrations and of the Common Administrative Procedure.

4. The Directorate-General for Pharmacy and Health Products shall keep up to date a register with all the communications referred to in the preceding paragraphs.

Article 13. Content of the communication.

1. The communication shall conform to the model set out in Annex XIII and shall contain at least the following data in the official Spanish language of the State:

a) Identification data of the person making the communication.

b) The class to which the product belongs.

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

d) Product type and model.

e) Description and destination of the product.

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

g) The identification number of the notified body or bodies involved in the assessment for the purposes of affixing the CE marking and applied annexes.

h) Labelling and instructions for use certified by the notified body.

(i) Labelling and instructions for use with which the product is to be marketed in Spain, in so far as the version in the official Spanish language of the State has not been certified by the notified body.

j) Date on which the product is placed on the market or in service in Spain.

k) Identification data of distributors in Spain, if they do not match the person mentioned in paragraph (a) of this article.

2. Any modification of the data referred to in the previous paragraph shall be communicated in accordance with the procedure laid down in Article 12. The cessation of marketing shall also be communicated.

Article 14. Register of persons responsible for the placing on the market of medical devices.

Any natural or legal person who manufactures or introduces in Spain for the placing on the market or putting into service products of classes I and IIa, as well as custom products, shall be included in the Register of marketing that will operate in the General Directorate of Pharmacy and Health Products, indicating its registered office and the relation of the products it markets or puts into service, specifying type of product, manufacturer, class and name commercial.

For this purpose, the interested parties shall carry out a communication in the Autonomous Community where the company has its registered office, in which the data referred to in the preceding paragraph is included, at the time the first paragraph is made effective. marketing of the product. The Autonomous Community will immediately move this documentation to the General Directorate of Pharmacy and Health Products.

This communication may be filed in any of the places provided for in Article 38 of the Law of Legal Regime of Public Administrations and of the Common Administrative Procedure.

Article 15. Information to the Autonomous Communities.

The records provided for in Articles 12 and 14 shall be kept at the disposal of the competent health authorities of the Autonomous Communities.

CHAPTER IV

Distribution and Selling

Article 16. Distribution and sale.

1. Only products complying with this Royal Decree and not expired shall be sold and distributed, taking as a reference for the latter the date referred to in paragraph (e) 7.3 of Annex I.

2. The distribution and sale shall be subject to the supervision and inspection of the health authorities of the Autonomous Community concerned, who may lay down the procedure required for the authorisation of such activities.

3. To this end, the natural or legal persons engaged in such activities shall inform the health authorities of the Autonomous Community in writing, in writing, stating:

a) Identification of distribution or sales premises.

b) Types of products that you distribute or sell.

c) Identification of the professional provided for in Articles 17 and 18 of this Royal Decree.

This communication shall be carried out without prejudice to the procedures to be performed as a manufacturer, importer or responsible for the placing on the market of the products referred to in Articles 5.1 and 14 respectively.

The pharmacy offices are exempt from such a declaration of activity.

Article 17. Distribution establishments.

1. The distributor shall maintain an orderly documentation of the products he or she distributes for use on national territory.

This documentation must contain at least the following data: product trade name, model, series and/or batch number, date of acquisition, date of shipment or supply and customer identification.

2. Whenever required, the distributor shall provide the health authorities, for the exercise of their respective powers, with the documentation which guarantees the conformity of the products with the provisions of this Royal Decree. If the distributor is not available for access to this documentation, it must be provided by the manufacturer.

3. In the event of suspicion or evidence of health risk, the distributor shall implement any measure of restriction or monitoring of the use of the appropriate products, as well as those which, where appropriate, may be determined by the health authorities.

4. The distributor must appoint a technician whose qualifications prove an appropriate qualification according to the nature of the products concerned. This technician shall be directly responsible for the execution of the activities contained in this article, and for the procedures referred to in Articles 12, 16, 19 and 25 of this Royal Decree, where applicable.

It will also be responsible for the technical-health information provided on the products marketed or put into service in Spain.

Article 18. Establishments of sale.

1. Establishments carrying out direct sales to the public of products requiring individualised adaptation must be equipped with the equipment necessary to make such an adjustment and to have a professional whose qualifications accredit a adequate qualification for these functions.

2. The sale through vending machines, designed for this purpose, may be carried out, provided that the integrity and safety of the product is not impaired.

3. Street vending is prohibited.

CHAPTER V

Clinical investigations

Article 19. Clinical investigations.

1. The conduct of clinical investigations with medical devices shall be in accordance with the provisions of Annex X and Titles I and III of Royal Decree 561/1993 of 16 April 1993 on clinical trials, with medicinal products, as specified in the Additional provision of the Royal Decree.

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, as referred to in Article 64 of Law 25/1990. of the Medication.

This forecast will be extended to changes in ongoing clinical investigations that may lead to increased risk for the subjects participating in the trial.

3. At least 60 days before the beginning of the investigations, the sponsor shall inform the General Directorate of Pharmacy and Health Products, accompanying the documentation referred to in paragraph 2.2 of Annex VIII.

This communication shall be carried out without prejudice to the communication required by the health authority of the Autonomous Community.

4. The Directorate-General of Pharmacy and Health Products shall acknowledge receipt of the communication to the sponsor at the same time as the promoter has entered the Register of such a management center and shall decide to authorize the investigations or to communicate a decision against based on considerations of public health or public order. Investigations may be initiated after 60 days from the acknowledgement of receipt by the Directorate-General for Pharmacy and Health Products.

5. If the documentation submitted is not complete or additional information is required, the sponsor shall be requested in writing. In the first case, the period of 60 days shall be interrupted on the date of issue of the document and shall be reinitiated from the date of entry into the General Directorate of Pharmacy and Health Products of the last information requested, and in the The second case will not interrupt the procedure to resolve, but its failure will generate the loss of the procedure.

6. By way of derogation from paragraph 4, in the case of products other than those of Class III or the long-term implantable or invasive classes of Classes IIa or IIb, clinical investigations may be initiated after a period of 15 days from the date of the Acknowledgement of receipt, provided that the favourable report of the Ethics Committee for Clinical Research is available.

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

8. The Directorate General of Pharmacy and Health Products will keep up to date a register with all the clinical investigations communicated. Such registration shall be kept at the disposal of the competent health authorities of the Autonomous Communities.

CHAPTER VI

Community Transactions and Foreign Trade

Article 20. Community circulation and import.

Products introduced from Community countries and imported from third countries may only be marketed and put into service in Spain if they comply with the requirements set out in this Royal Decree.

Article 21. Export.

Products which 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 differ from those intended for Community market, with a view to preventing its use in the Community market.

CHAPTER VII

Performances of public administrations

Article 22. Notified bodies.

1. The Ministry of Health and Consumer Affairs shall designate the bodies which shall carry out the procedures referred to in Articles 8 and 10, 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 Gazette of the State' together with the identification number assigned by the Commission and the specific tasks.

The Ministry of Health and Consumer Affairs will carry out the necessary actions to check the suitability of the organisms in order for their designation and to verify the maintenance of these skills in the designated bodies.

2. Notified bodies shall comply with the requirements set out in Annex XI. Bodies meeting the criteria laid down in the national rules 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 requirements laid down in Annex XI, the Ministry of Health and Consumer Affairs shall withdraw the authorisation, subject to the corresponding administrative procedure, with hearing the person concerned, and shall inform the Commission of the European Communities and the other Member States thereof.

4. In the event of the cessation of duties of a notified body, the Ministry of Health and Consumer Affairs shall take appropriate measures to ensure the continuity of the management of conformity assessment procedures.

Article 23. 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.

2. The notified body and the manufacturer or his authorised representative established within the Community shall establish by common agreement the time limits for the completion of the conformity assessment procedures to which the products are to be submitted.

The documentation corresponding to these evaluation procedures will be drawn up, at least, in the official Spanish language of the State. However, the notified body may accept the presentation in another language of scientific or specialised documentation which is part of the conformity assessment.

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

3. In the assessment of the conformity of a product, the notified body shall take into account the results available under assessment and verification operations which have taken place, where appropriate, in accordance with the provisions of this Royal Decree, in an intermediate stage of manufacture. They shall also take into account the results of the assessment carried out in accordance with the national legislation in force on 31 December 1994 in any country of the European Union.

4. Decisions taken by the notified body in accordance with Annexes II and III shall specify their period of validity, which shall not exceed five years, and may be extended for periods of five years following the application of the manufacturer and the notified body's agreement.

5. Where the notified body refuses or withdraws any of the certificates or authorisations provided for in Annexes II to VI, it shall forward a copy of the refusals agreement to the Directorate-General for Pharmacy and Health Products.

6. Where it is found that the CE marking has been affixed unduly, the notified body concerned shall withdraw or temporarily suspend the relevant authorisation or certificate, informing the Directorate-General of the Pharmacy and Sanitary Products, who will transfer to the Autonomous Communities.

7. Against the decisions taken by the notified body, in accordance with paragraphs 5 and 6 of this Article, the person concerned may express his disagreement with the body itself and, in the event of the disagreement, The Minister for Health and Consumer Affairs, who, after examining the appropriate procedure, with a hearing of the person concerned, shall decide within the maximum period of three months. An ordinary appeal may be brought against that decision within one month, in accordance with Article 114 of the Law on the Legal Regime of Public Administrations and the Common Administrative Procedure.

Article 24. Inspection.

1. The competent bodies of the Autonomous Communities shall carry out periodic inspections to verify that the products placed on the market and put into service are in conformity with this provision.

2. The Directorate-General for Pharmacy and Health Products may carry out inspection and control activities in respect of products intended for external trade and of establishments in which they are manufactured or exported, provided that they are situated in the on national territory. It may also carry out, without prejudice to the powers of other health authorities, the inspection and monitoring of clinical investigations of products which do not bear the CE marking.

3. The staff at the service of the public administrations who carry out the inspection functions shall proceed as provided for in Article 105 (3) of Law 25/1990 of 20 December of the Medication and may also request the responsible for the placing on the market of information on the documentation of products placed on the market or put into service in Spain and those submitted for clinical investigation.

4. The authorities of the General Administration of the State and the competent Autonomous Communities shall assist each other for inspection purposes.

Within the Interterritorial Council of the National Health System, appropriate measures will be taken to promote cooperation and mutual assistance between the state and regional health authorities. establish specific control programmes with reference to the nature, extent, intensity and frequency of the checks to be carried out.

Article 25. Surveillance system.

1. Where, on the occasion of their activity, the health professionals, the inspection authorities, the manufacturers or the persons responsible for the products warn of any dysfunction, alteration of the characteristics or the performance of the product, as well as any inadequacy of the labelling or package leaflet which may or may have resulted in the death or serious deterioration of the health status of a patient or a user,

must inform the General Directorate of Pharmacy and Health Products, where such data will be evaluated and recorded.

This communication shall be carried out without prejudice to the communication required by the health authority of the Autonomous Community. The manufacturer shall be informed of these facts.

2. Similarly, the manufacturer or any other person responsible for the product shall notify the withdrawal of the market of a product caused by technical or health reasons related to one of the circumstances mentioned in the previous paragraph.

3. After having carried out their assessment, if possible jointly with the manufacturer, these facts and the measures taken shall be communicated to the European Commission and to the other Member States by the Directorate-General for Pharmacy and Health Products.

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

a) Heart and vascular implants.

b) Central nervous system implants.

c) Nervous and muscle stimulators.

d) Backbone implants.

e) Implantable infusion pumps.

f) Hip protein.

g) Knee protein.

h) Breast proteis.

i) Intraocular Lents.

This 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 healthcare centre where the implementation and date of the implementation, 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 another will be sent to the supplying company. In the case where a national register of implants has been provided, this copy or copy thereof shall be sent to the national register by the supplying undertaking.

Article 26. Health protection measures.

1. If there is any doubt as to the conformity of a product, the health authorities may require the manufacturer, importer or person responsible for placing the product on the market in the official Spanish language of the State of how much information is given. considers it necessary to judge on that conformity.

The refusal to provide the documentation referred to may be considered as a presumption of non-compliance with the essential requirements.

2. Where the person responsible is a legal entity other than the manufacturer or his authorised representative in the Community, he shall jointly respond to the conformity of the products and must demonstrate his/her ability to assume the responsibilities arising from this Article and from Article 25. Depending on the class of risk of the products, this demonstration may require express certification from the manufacturer of the product or from his authorised representative.

3. As a guarantee of the health and safety of persons, the competent health authorities, when they consider that a product once put into service and being used correctly according to their destination, may compromise health and/or the safety of the patients or the safety of third persons, shall take the appropriate measures provided for in Articles 24, 26 and 28 of Law 14/1986 of 25 April, General of Health, and in Article 106 of Law 25/1990 of 20 December of the Medicinal product.

Such measures will be previously brought to the attention of the manufacturer, unless urgent reasons for their adoption are met.

4. The Directorate-General for Pharmacy and Health Products shall be informed immediately by the health authority which adopted the measure, indicating the reasons for the precautionary measure.

5. The Directorate-General for Pharmacy and Health Products shall immediately inform the Commission of the European Community of the measures taken.

6. Where a product does not bear the CE marking, the health authorities of the Autonomous Community concerned shall take appropriate measures and shall inform the Directorate-General of Pharmacy and Health Products thereof. It shall act accordingly and shall communicate it to the Commission of the European Communities.

7. The communication to the European Commission shall not be necessary where the non-compliance concerns the non-compliance with the provisions referred to in Articles 5.1, 5.3, 12, 13 and 14 of this Royal Decree.

8. Where, at the initiative of the manufacturer or distributor of the products, measures for the prevention, warning or withdrawal of products from the market are agreed, as well as the dissemination of warnings relating to medical devices, they shall be knowledge of the competent health authorities prior to their commencement. Those authorities may determine the appropriateness of implementing the proposed measures and may prevent or amend them for justified reasons of public health.

9. In all cases of non-conformity, the manufacturer, his authorised representative or, where appropriate, the person responsible for the product in Spain, shall be obliged to take the appropriate measures to ensure that the situation of non-conformity is terminated, under the conditions laid down in Article 1 (2) of the Directive. established by the competent authority. The persistence of non-conformity shall lead to the prohibition or restriction of the placing on the market or putting into service of the product or its withdrawal from the market, following the procedure laid down in this Article.

10. Where the verification of the non-conformity of a product requires the performance of evaluations or tests on the product or its technical documentation, the costs resulting from such verification, if the product does not comply, shall be satisfied by the manufacturer or his/her person, who shall also provide the samples necessary to carry out such verification.

11. 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 the withdrawal of a product from the market is carried out, the the person concerned may express his disagreement to the hierarchical superior body of which the decision has been taken, by means of the appropriate ordinary appeal within one month, in accordance with the provisions of Articles 114 and Legal status of public administrations and the common administrative procedure.

Article 27. Express authorisations.

The General Directorate of Pharmacy and Health Products may expressly and individually authorize, in the interests of health protection, the placing on the market and putting into service of products for which they are not satisfied the conformity assessment procedures referred to in Article 8 of this Royal Decree.

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.

Article 28. Confidentiality.

Public administrations, without prejudice to the existing provisions on professional secrecy, shall ensure that all parties to which the application of this Royal Decree is concerned maintain confidentiality. of any information obtained in the exercise of its function. This shall not affect the obligations of the notified bodies with regard to reciprocal information, the dissemination of warnings or the reporting obligations incumbent upon the persons concerned, both before the authorities, and the courts.

CHAPTER VIII

Advertising and exhibitions

Article 29. Advertising and presentation of products.

1. Advertising aimed at the promotion of products shall be governed by the general principles laid down in Law 34/1988 of 11 November, General of Advertising, as well as in Article 102 of Law 14/1986 of 25 April, General of Health.

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

3. 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.

4. Where, by reason of the nature of the medical device, direct advertising is made to the public, account shall be taken, in particular, of the provisions of Article 5 (4) of this Royal Decree. Advertising messages which are inserted in any means of public dissemination will be subject to prior authorisation by the health authorities of the Autonomous Communities. Any other promotional text shall be made available to the health authorities concerned for at least three months after disclosure.

5. In particular, advertising or promotional texts must indicate the contraindications and any possible side effects which may arise from the use of these products.

6. Any mention in the advertising of products made by individuals referring to a health authority, as well as to the obtaining of an EC certificate or a marketing authorisation, is prohibited.

No reference may be made to recommendations made by scientists, health professionals or other persons who may, due to their notoriety, incite their use.

7. In accordance with Article 27 of Law 14/1986, of 25 April, General of Health, it is forbidden the advertising of any product that without adjusting to the established in this Royal Decree intends to carry out some of the intended purposes in the article 3 (a) or (b) of this Royal Decree.

Article 30. Incentives.

1. In the framework of the promotion of medical devices, it is prohibited to grant, offer or promise premiums, pecuniary advantages or benefits in kind to healthcare professionals or any other qualified person related to the use, prescription or dispensing of the products as well as their relatives and people of their coexistence.

2. Persons listed in the previous paragraph may not apply for or accept any of the prohibited incentives.

Article 31. 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 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 dispensing of sanitary products shall apply exclusively for activities of a scientific nature where the addressees are optional in clinical practice 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.

3. This article does not affect the training courses required for the correct use of the products, which are provided to the professionals by the manufacturers or distributors thereof.

Article 32. Exhibitions.

At trade fairs, exhibitions and demonstrations, products which do not comply with the provisions of this Royal Decree may be presented, provided that they are in a sufficiently visible sign, placed on or next to the products themselves, it is clearly stated 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 non-compliant products in patients.

CHAPTER IX

Violations and penalties

Article 33. Infringements.

The actions and omissions provided for in Article 35 of Law 14/1986, of 25 April, General of Health, and the following specific actions shall be taken into account for violations of the provisions of this Royal Decree:

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 impossibility of putting into service.

2. ª hinder the inspection by any action or omission that disturbs or delays the same.

3. The use by a professional of sanitary products under conditions and for uses other than those indicated by the manufacturer, or by personnel who are not qualified or duly trained.

4. The non-compliance with the requirements, obligations or prohibitions established in this Royal Decree which, by reason of the criteria referred to in this article, deserve the qualification of mild or not to carry out their qualification as serious or very serious faults.

2. Serious breaches:

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

2. Failure to comply with a technical officer in accordance with Articles 5.1 and 17.4 or with a qualified professional in accordance with Article 18.1.

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

4. The failure to comply with the obligation to communicate on the market and the amendments to those communications, as set out in Articles 12.1 and 13.2 respectively.

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

6. The lack of maintenance at the disposal of the competent authorities and for the time indicated in the documentation referred to in Articles 9.3 and 5, 10.4, 17.1 and 25.4, Annexes II to VIII and the relevant provisions.

7. Do not carry out the communication provided for in Article 14 of this provision.

8. Distribute and sell sanitary products in establishments that have not been properly communicated in accordance with Article 16.3.

9. To distribute, maintain and use sanitary products without observing the required conditions, as well as to put on sale altered sanitary products, in poor conditions or when the term of validity has been exceeded.

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

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

12. The breach of the duty of communication provided for in Article 25 of this Royal Decree.

13. Failure to comply with the requirements relating to the advertising and promotion of medical devices and the conditions laid down in Article 29.

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

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

3. Very serious breaches:

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

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

3. The misuse of the CE marking.

4. Failure to comply with the obligation to implement the measures and actions provided for in Articles 17.3 and 26.3, 8 and 9 of this Royal Decree.

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

6. The incorrect execution, by the notified body, of the actions entrusted to them in Article 23 of this Royal Decree, as well as to continue to certify once the corresponding designation has been withdrawn.

7. The violation of the principle of confidentiality established in Article 28 of this Royal Decree.

Article 34. Sanctions.

1. The actions and omissions constituting infringements, as provided for in Article 33 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 33 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 Health, and the criteria expressed in the Article 109 of Law 25/1990 of 20 December of the Medication.

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

Additional disposition first. Basic character.

1. Article 1 (2) of this Royal Decree, which is given in the development of the final provision of Law 25/1990 of 20 December 1990, has the character of legislation on pharmaceutical products in accordance with the provisions of the Article 149.1.16. of the Constitution and article 2.1 of Law 25/1990 of 20 December of the Medication.

2. They have the status of basic health standard, as laid down in Articles 149.1.1. and 16. of the Constitution, 1.3, 2.2 and 8.12 and additional provision third of Law 25/1990 of 20 December of the Medication, and 40.5 and 6, 95, 100 and 110 of Law 14/1986, of 25 April, General of Health, all other articles, provisions and annexes of this Royal Decree.

3. Article 20, as regards the importation of products, and Article 21 of this Royal Decree are issued under the terms of Article 149.1.10. and 16. of the Constitution.

Additional provision second. Criteria for the financing of health services.

The provisions of this Royal Decree will not affect the criteria for the financing of health services to be adopted by the competent health authorities.

Additional provision third. Evaluation procedures.

The implementation of the conformity assessment procedures, as set out in Articles 8, 9 and 10 of this provision, will be independent of the certification of industrial quality as set out in Law 21/1992, of July 16, Industry.

Additional provision fourth. Application of fees.

The procedures referred to in Articles 12, 19.3 and 19.7 shall apply to them the fee referred to in paragraph 3.3, of Group III of Title X of Title X of Law 25/1990 of 20 December of the Medication.

Additional provision fifth. Extension.

The content of this Royal Decree will apply, by extension, to the following products:

Contact lenses for no corrective purpose.

Tattoo products.

These products must meet the essential requirements that apply to them. Their manufacture, distribution and sale shall be subject to supervision by the competent health authorities, and shall comply with the procedures laid down in Articles 5.1, 16, 17 and 18.

However, such products may not be marked "CE".

Additional provision sixth. Amendments to Royal Decree 643/1993 of 3 May.

In accordance with Article 21 of Directive 93 /42/EEC and Article 9 of Directive 93 /68/EEC, the following amendments are made to Royal Decree 634/1993 of 3 May on active implantable medical devices:

A) Article 1. Scope of application.

The following paragraph 4 is added:

" 4. This Royal Decree provides for the transposition of Directive 90 /385/EEC on active implantable medical devices, which constitutes a specific Directive within the meaning of Article 2 (2) of Directive 89 /336/EEC on compatibility electromagnetic.

Consequently, the active implantable medical devices whose conformity has been determined in accordance with this Royal Decree do not result from the application of Royal Decree 444/1994 of 14 March 1994, for which establish the conformity assessment procedures and the requirements for the protection of electromagnetic compatibility of equipment, systems and installations transposing Directive 89 /336/EEC. '

B) Article 2. Definitions: The following paragraphs are added:

(h) Marketing: 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, irrespective of whether it is an active, new or fully renovated, implantable medical device.

i) Manufacturer: the natural or legal person responsible for the design, manufacture, conditioning and labelling of an active implantable medical device, with a view to the placing on the market of it in its own name; whether these operations are carried out by the same person or by a third party on behalf of the person concerned.

The obligations of this Royal Decree to which the manufacturers are subject shall also apply to the natural or legal person who assembles, put up, treats, totally renews and/or assigns them a purpose as a product with a view to to the marketing of the same in its own name. This subparagraph shall not apply to a person who, without being a manufacturer under the first subparagraph, is to assemble or adapt, in accordance with his intended purpose, products already on the market for a particular patient.

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

C) Article 3. Health and safety guarantees.

The title of this article is replaced by "General Conditions".

Paragraph 2 is replaced by the following:

" 2. In accordance with Article 100 of Law 14/1986 of 25 April 1986 on certain activities in relation to medical devices, the manufacture, grouping or sterilisation of the implantable medical devices active in the national territory, shall require prior operating licence of the installation, granted by the Directorate-General of Pharmacy and Health Products. In the same way, it shall require the prior authorisation of establishments located in national territory where the importation of implantable medical devices active from third countries is carried out for the placing on the market or service on Community territory.

In order to carry out the activities referred to in the previous paragraph, the companies will have a technical officer, entitled university, whose qualifications accredit a suitable qualification, who will exercise supervision direct of such activities. "

Paragraphs 3 and 4 are added with the following text:

" 3. At the time of their entry into service in Spain, the products must include the data and information contained in point 3 of Annex I, at least in the official Spanish language of the State, in order to allow for the availability of certain and objective information which is effective, truthful and sufficient about its essential characteristics.

4. 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. "

D) Article 5. CE conformity marking:

Paragraph 1 is replaced by the following:

" 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 health products to be measured and those intended for clinical investigation shall be governed by Article 7.

The CE marking may be affixed only to products which have demonstrated their conformity with the essential requirements referred to in Article 4 and which have followed the conformity assessment procedures identified in the Article 6. "

Paragraph 4 is replaced by the following text:

" 4. No other marking may be affixed to the product which may give rise to confusion with the 'EC' conformity marking. If the product, its package leaflet or its packaging contains any other mark, the visibility and legibility of the CE marking shall not be reduced. '.

The following paragraph 5 is added:

" 5. In the case of products to which other Community Directives or national provisions which have transposed them apply, in respect of other aspects in which the affixing of the CE marking is provided for, only the affixing of the marking marking if the products also comply with the relevant provisions of those other Directives or national provisions.

However, if one or more of those Directives or national provisions transposing them would allow the manufacturer, during a transitional period, to choose which measures to apply, the CE marking shall indicate that the products only comply with the provisions of the national Directives or provisions applied by the manufacturer.

In such a case, the references of those Directives as published in the Official Journal of the European Communities must appear in the documentation, the prospectuses, or the instructions provided by the Directives or national provisions accompany these products. Such documents must be accessible without the packaging which in their case ensures the sterility of the product being destroyed. "

E) Article 6. Conditions for affixing the CE marking.

The following paragraph 2 is added:

" 2. The manufacturer may also instruct his authorised representative established in the Community to initiate the conformity assessment procedures set out in Annexes III, IV and VI. "

F) Article 16. Notified bodies.

Paragraph 1 is replaced by the following:

" 1. The Ministry of Health and Consumer Affairs shall designate the bodies which shall carry out the procedures referred to in Article 6 and the specific tasks assigned to each body and shall notify the European Commission and the other Member States thereof. Such designation shall be published in the "Official Gazette of the State", together with the identification number assigned by the Commission and the specific tasks.

The Ministry of Health and Consumer Affairs shall carry out the necessary actions to check the suitability of the bodies in order to designate them and verify the maintenance of these skills in the designated bodies. "

Paragraph 2 is replaced by the following:

" 2. Notified bodies shall comply with the requirements set out in Annex VIII. 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 bound by them. '

G) Article 17. Actions of the notified body.

In paragraph 2, a third paragraph is inserted, with the following text:

"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 procedure chosen."

Paragraphs 6 and 7 are added with the following text:

" 6. 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. It shall also take into account the results of the assessment carried out in accordance with the national legislation in force on 31 December 1992 in any country of the European Union.

7. Decisions taken by the notified body in accordance with Annexes II and III shall specify their period of validity which shall not exceed five years and may be extended for a period of five years following the request of the manufacturer and the notified body's agreement. '

H) Article 20. Precautionary measures.

The title of this article is replaced by the title "Health Protection Measures".

In paragraph 1, the following sentence is added:

"Such measures shall, in advance, be brought to the attention of the manufacturer, unless urgent reasons for their adoption are met."

Paragraphs 5, 6, 7, 8, 9 and 10 are added with the following text:

" 5. Communication to the Commission shall not be necessary where the lack of conformity concerns the failure to comply with the provisions referred to in Articles 3.2, 3.3, 9, 10 and 11 of this Royal Decree.

6. Where, on the initiative of the manufacturer or distributor of the products, measures for the prevention, warning or withdrawal of products on the market are agreed, as well as the dissemination of warnings relating to medical devices, they shall be knowledge of the competent health authorities prior to their commencement. Those authorities may determine the appropriateness of implementing the proposed measures and may prevent or amend them for justified reasons of public health.

7. In all cases of non-conformity, the manufacturer, his authorised representative or, where appropriate, the person responsible for the product in Spain, shall be required to take the appropriate action to ensure that the situation of non-conformity is not satisfied. established by the competent authority. The persistence of non-conformity shall lead to the prohibition or restriction of the placing on the market or putting into service of the product or its withdrawal from the market, following the procedure laid down in this Article.

8. The Directorate-General for Pharmacy and Health Products may expressly and individually authorize, in the interests of health protection, the placing on the market and putting into service of products for which the procedures for conformity assessment referred to in Article 6 of this Royal Decree.

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

9. Where the verification of the non-conformity of a product requires the performance of evaluations or tests on the product or its technical documentation, the costs resulting from such verification, if the product does not comply, shall be satisfied by the manufacturer or his/her responsible person, who shall also provide the samples necessary to carry out such verification.

10. 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 the withdrawal of a product from the market is carried out, the the person concerned may express his disagreement to the hierarchical superior body of which the decision has been taken, by means of the appropriate ordinary appeal within one month, in accordance with the provisions of Articles 114 and Legal status of public administrations and the common administrative procedure. '

I) Annex II. EC declaration of conformity (complete system of quality assurance):

Paragraph 2 of paragraph 2 is replaced by the following:

" The manufacturer, or his authorised representative established on the territory of the Community, shall affix, in accordance with Articles 5 and 6, the CE marking and shall draw up a declaration of conformity.

This declaration shall relate to one or more identified copies of the product and shall be retained by the manufacturer or his authorised representative established in the territory of the Member States.

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

Paragraph 6 is replaced by the following:

" 6. Administrative provisions.

6.1 The manufacturer shall keep at the disposal of the competent authorities for a period of at least five years from the last date of manufacture of the product: the declaration of conformity, the documentation to which it is refers to the second indent of paragraph 3.1, the amendments referred to in paragraph 3.4, the documentation referred to in paragraph 4.2, the decisions and reports of the notified body referred to in paragraphs 3.3, 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.

6.3 Where neither the manufacturer nor his representative is established on the territory of the Community, the obligation to keep the technical documentation referred to in paragraph 4.2 at the disposal of the authorities shall be the responsibility of the manufacturer. person responsible for placing the product on the Community market. '

J) Annex III. EC model examination:

Paragraphs 7 and 8 are replaced by the following text:

" 7. Administrative provisions.

7.1 Each notified body shall make available to the other notified bodies and the competent authority, at their request, all relevant information concerning the EC type-examination certificates and the Amendments issued, 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, together with the technical documentation, keep a copy of the EC type-examination certificates and their supplements for a period of at least five years from the last date of Manufacture of the product.

7.4 Where neither the manufacturer nor his representative is established on the territory of the Community, the obligation to keep the technical documentation at the disposal of the authorities shall be the responsibility of the person responsible for the marketing of the product on the Community market. '

K) Annex IV. EC verification:

This annex is replaced by the following text:

" 1. EC verification is the procedure whereby the manufacturer or his authorised representative established on the territory of the Community ensures and declares that the products complying with the provisions of paragraph 5 are in accordance with the type described in the 'EC type' certificate and comply with the requirements of this provision which apply to it.

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 established on the territory of the Community shall affix the CE marking to each of the products and draw up 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, as well as the set of pre-established and systematic provisions which shall be applied in order 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 create and update a post-sale control system. 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 alteration of the characteristics and performance, as well as any inadequacy of the instructions for use of a product that may cause or cause the death or deterioration of a patient's health status;

(ii) any technical or health reason which has caused the manufacturer to withdraw a product from the market under the circumstances set out in the preceding paragraph.

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 8, 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 performed by attributes, which will involve a sampling plan with the following characteristics:

A quality level equivalent to an acceptance probability of 95 per 100, with a percentage of non-compliance between 0.29 and 1 per 100.

A limit quality equivalent to an acceptance probability of 5 per 100, with a percentage of non-compliance between 3 and 7 per 100.

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. 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 representative must be able to present, if requested, the certificates of conformity of the notified body. "

L) Annex V. EC declaration of conformity with the model (quality assurance of production).

The second subparagraph of paragraph 2 is replaced by the following:

" The manufacturer or his authorised representative established within the Community shall affix the CE marking in accordance with Articles 5 and 6 and extend a written declaration of conformity. This declaration shall cover one or more identified specimens of the product, which must be kept by the manufacturer. The CE marking shall be accompanied by the identification number of the notified body responsible. '

M) Annex IX. CE conformity marking.

This annex is replaced by the following text:

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

(IMAGE 1 OMITIDA)

If the size of the CE marking 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 in the case of small-scale products are permitted. "

N) Single transient provision. It becomes the first transitional provision.

The following transient disposition is added:

" Second transient disposition.

The placing on the market and putting into service of products which are in conformity with the CE marking systems in force before 1 January 1995 is authorised until 1 January 1997. "

N) In all the text of the Royal Decree the terms:

"CE Model Examination" is replaced by "CE" "Browse".

"CE Model Certificate" by "CE Certificate of Type" ".

Additional provision seventh. Records of medical devices.

The Registers which were established in the Decree of 29 May 1957 and in the Order of 5 May 1964 for sterile dressings and spreaders, respectively, become specific records of medical devices during the transitional period laid down in the first transitional provision.

Additional disposition octave. Publication of lists of notified bodies.

The Ministry of Health and Consumer Affairs will announce in the "Official State Gazette" lists of the notified bodies within the framework of Directives 90 /385/EEC and 93 /42/EEC published in the Official Journal of the European Communities. (DOCE).

Additional provision ninth. Implementation of the Agreement on the European Economic Area.

For the purposes of this Royal Decree, the provisions of the Agreement on the European Economic Area shall apply.

First transient disposition. Validity of the previous legislation on medical devices.

1. Until 14 June 1998, the placing on the market and putting into service of medical devices complying with the regulations in force in Spain will be allowed on 31 December 1994.

2. Until 14 June 1998, the free marketing and entry into service of medical devices which are not subject to any national legislation on 31 December 1994 will be permitted.

Second transient disposition. Adaptation of the obligations on marketing communication.

Companies responsible for products that are already legally marketed in Spain at the entry into force of this Royal Decree, must comply with the provisions of Article 12 at the time of their commencement. placing on the market "CE". If they were already marketing products with CE marking, they shall have three months to comply with that requirement.

A communication of the products referred to in paragraph 1 of the first transitional provision shall not apply to them the fee set out in the fourth provision.

Transitional provision third. Duration of the previous legislation on clinical thermometers.

Until 30 June 2004, the placing on the market and putting into service of those medical devices which have been the subject of the EC model approval referred to in the Order of 30 December 1988, for which the regulate the clinical thermometers of mercury, in glass and with maximum device.

Transitional disposition fourth. The validity of the legislation on manufacturing and import activities.

Until 14 June 1998, the manufacture and import of medical devices will be permitted under the conditions laid down by the regulations in force in Spain on 31 December 1994. Until the same date, the free manufacture and import of medical devices will be permitted until the same date, which, on 31 December 1994, would not be subject to the conditions laid down for such activities.

Transient disposition fifth. Adaptation of the legislation on distribution and sale.

The deadline of one year from the entry into force of this Royal Decree is fixed as a deadline for the distribution and sale establishments to carry out the communication referred to in Article 16 (3).

First repeal provision. Regulatory repeal.

1. Paragraphs (a), (b) and (c) of Article 3 and the first, second and third final provisions of Royal Decree 908/1978 of 14 April 1978 on health control and approval of medical, therapeutic and corrective equipment and instruments are hereby repealed.

2. The following provisions are hereby repealed with effect from 14 June 1998:

(a) Royal Decree 1231/1983 of 20 April establishing the subjection to technical standards of electromedical devices for the monitoring of intensive patient surveillance, as amended by Royal Decree 895/1984, April 11.

(b) Royal Decree 2954/1983 of 4 August 1983 laying down technical specifications for rotary anode X-ray tubes and tubes equipped for medical diagnosis, as amended by the Royal Decrees 1265/1984 of 6 June 1984 and 1144/1986 of 25 April 1986.

c) Royal Decree 1249/1985, of 19 June, establishing the subjection to technical specifications of the tables for the radiological diagnosis.

(d) Royal Decree 1252/1985 of 19 June laying down the technical specifications of X-ray generators for medical diagnostic radio.

e) Royal Decree 2603/1985 of 20 November, establishing the subjection to technical specifications of the radiosurgical apparatus.

(f) Royal Decree 2395/1986 of 22 August 1986 laying down the technical specifications of equipment for electrosurgery with a high frequency current.

(g) Decree of 29 May 1957 on the health conditions of cotton, hydrophilo, hydrophila gauze and dressings.

(h) Royal Decree 1082/1991 of 28 June 1991 laying down the technical and health conditions for products for the care and maintenance of contact lenses.

(i) Royal Decree 1688/1991 of 22 November 1991 laying down the technical and health conditions of the rubber condoms and declaring that they must be approved for health purposes.

j) Order of 5 May 1964 on the registration of various products in the Special Register.

And the rest of the provisions for approval and sanitary registration of medical devices.

All as long as they object to the present Royal Decree and in the field of the products defined in Article 3, with the exception of paragraph c).

Repeal provision second. Special derogation rules.

As of 14 June 1998, Royal Decree 65/1994 is hereby repealed, concerning the safety requirements of electrical equipment used in medical and veterinary medicine, with regard to the use of equipment in human medicine, remaining in force for applications in the veterinary field.

Single end disposition. Faculty of development.

The Minister of Health and Consumer Affairs is empowered to issue any provisions necessary for the implementation and development of this Royal Decree, as well as for the updating of the relations of products established in the Article 25 (4) and the fifth additional provision.

Given in Madrid on March 1, 1996.

JOHN CARLOS R.

The Minister of Health and Consumer Affairs,

MARIA ANGELES AMADOR MILLAN

ANNEX I

Essential design and manufacturing requirements

1. Chemical, physical and biological properties

1. Products must be designed and manufactured in such a way as to ensure the characteristics and benefits referred to in Article 6, "Essential requirements" of this Royal Decree, with particular attention to: the choice of materials used, in particular as regards the toxicity and, where appropriate, flammability; the reciprocal compatibility between the materials used and the biological tissues, cells and body fluids, taking into account the intended purpose of the product.

2. The products must be designed, manufactured and

to be conditioned in such a way as to minimise the risk presented by contaminants and residues for personnel involved in transport, storage and use, as well as for patients, in accordance with the purpose product. Particular attention should be paid to the exposed tissues and the duration and frequency of exposure.

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

4. 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 1 of Directive 65 /65/EEC and which may have an effect on the human body, ancillary to the product, safety, quality and usefulness of such a substance, taking into account the intended purpose of the product, shall be verified by analogy with the appropriate methods laid down in Directive 75 /318/EEC.

5. The products must be designed and manufactured in such a way as to minimise the risks arising from the substances released by the product.

6. Products shall be designed and manufactured in such a way as to reduce as far as possible the risks arising from the unintentional incorporation of substances into the product, taking into account the product concerned and the type of environment in which it is intended. to be used.

2. Microbial infection and contamination

1. products and their manufacturing processes must be designed in such a way as to eliminate or reduce the risk of infection to the patient, the user and third parties as much as possible. The design shall allow easy handling and, whenever indicated, minimise the contamination of the product by the patient or vice versa during use.

2. Tissues of animal origin must come from animals which have been subjected to appropriate veterinary checks and monitoring in the light of the use to which such tissues are intended.

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

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

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

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

5. The products to be sterilized must be manufactured under well controlled conditions (for example, those relating to the environment).

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

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

3. Properties relating to manufacturing and the environment

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

2. Products shall be designed and constructed in such a way as to eliminate or reduce as much as possible: the risks of injury linked to their physical characteristics, including the volume/pressure ratio, the dimensional characteristics and, where appropriate, ergonomics; risks linked to reasonably foreseeable environmental conditions such as magnetic fields, external electrical influences, electrostatic discharges, pressure, temperature or variations in pressure or acceleration; risks of reciprocal interference with other products, used normally for investigations or treatments carried out; the risks arising, in the event of impossibility of maintenance or calibration (e.g. in the case of implantable products), of the ageing of the materials used or of the loss of precision of a measurement or control mechanism.

3. The products must be designed and constructed in such a way as to minimise the risks of fire or explosion if they are normally used and under conditions of first defect. Particular attention must be paid to products intended to bring exposure to flammable substances or substances capable of promoting combustion.

4. Products with measurement function

1. Products with a measurement function shall be designed and constructed in such a way as to provide sufficient accuracy and accuracy of the measurement within the accuracy limits appropriate to the purpose of the product. The precision limits shall be indicated by the manufacturer.

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

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

5. Radiation protection

1. General requirements:

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

2. Deliberate radiation:

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

(b) When products are intended to emit potentially dangerous, visible and/or invisible radiation, they shall be equipped, if possible, with visual and/or sound indicators to indicate the emission of radiation.

3. Unintended radiation:

Products must be designed and manufactured in such a way as to minimise the exposure of patients, users and others to non-intentional, parasitic or dispersed radiation emissions.

4. Instructions for use:

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

5. Ionising radiation:

(a) As far as possible, products emitting ionising radiation must be designed and manufactured in such a way as to enable the quantity, geometry and quality of radiation emitted according to the quantity to be regulated and controlled. the objective pursued.

(b) Products emitting ionising radiation for radiological diagnosis must be designed and constructed to ensure a good quality of image and/or result in accordance with the medical purpose to be pursued, with a minimum exposure of the patient and the user to radiation.

(c) Products emitting ionising radiation intended for radiation therapy shall be designed and constructed in such a way as to enable reliable monitoring and control of the doses administered, the type of beam, the energy and, where appropriate, the type of radiation.

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

1. Products incorporating programmable electronic systems shall be designed in such a way as to ensure the repeatability, reliability and effectiveness of such systems, in line with the use to which they are intended. In the case of conditions of first defect in the system, provision should be made for the means to be able to eliminate or reduce the risks involved as much as possible.

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

3. Products connected to an external energy source from which the safety of patients is dependent shall include an alarm system indicating any failure of the power source.

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

5. Products shall be designed and constructed in such a way as to minimise the risks of creating electromagnetic fields which may affect the operation of other products or equipment located in their normal environment.

6. Protection against electrical risks.

Products must be designed and constructed in such a way that, when properly installed and used normally or under first defect conditions, the risks of accidental electrical shock are avoided as much as possible.

7. Protection against mechanical and thermal hazards:

(a) The products must be designed and manufactured in such a way that the patient and the user are protected from the related mechanical risks, for example, with the resistance, stability and moving parts.

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

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

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

e) The accessible parts of the products (excluding parts or areas intended to provide heat or to reach certain temperatures) and their environment shall not be able to reach temperatures that may represent a danger under normal conditions of use.

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

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

(b) The product must be provided with means to prevent and/or to indicate any correction of the rate of supply of the product when there is a danger.

Products must be equipped with adequate means to prevent, within the limits of what is possible, the accidental release of dangerous quantities of energy from a source of energy and/or substances.

9. The function of the controls and indicators shall be clearly indicated in the products.

Where a product is accompanied by instructions necessary for its use or indications of control or control by means of a visual system, such information shall be comprehensible to the user and, if appropriate, to the user. the patient.

7. Data provided by the manufacturer

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

This information is made up of the information listed on the label and those contained in the instructions for use.

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

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

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

3. The label must include the following data:

(a) The name or the name or the social reason and the address of the manufacturer. As regards products imported into the Community with a view to their distribution, the label, outer packaging or instructions for use must also include the name and address of the person concerned. established in the Community territory responsible for the placing on the market of products of class I or products to measure, of the authorised representative of the manufacturer established on the territory of the Community or of the importer established in the Community territory, as appropriate.

manufacturers, for the purposes of this paragraph, are considered to be the person who groups products with "CE" marking in order to market them as systems, assemblies or equipment and the person sterilizing products with CE marking for your marketing;

b) The information strictly necessary for the user to identify the product and contents of the package.

c) When appropriate, the word "sterile".

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

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

f) The indication, where appropriate, that the product is for single use only.

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

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

i) Specific storage and/or conservation conditions.

j) Special instructions for use.

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

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

m) Where appropriate, the sterilization method.

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

5. The products and their separable components must be identified, where appropriate, in terms of lots, if this is reasonably practicable, in order to enable any appropriate measures to be taken to detect a possible risk for the products and their separable components.

6. The instructions for use shall include, as appropriate, the following data:

(a) The particulars referred to in paragraph 7.3, except those set out in paragraphs (d) and (e).

(b) The benefits referred to in Article 6.2 and any undesirable side effects.

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

(d) All data to verify whether the product is properly installed and capable of functioning properly and safely, as well as data relating to the nature and frequency of maintenance operations and calibration to be carried out in order to ensure a permanent guarantee of the proper functioning and safety of the products.

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

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

g) The necessary instructions in case of breakage of the sterility protective package and, where appropriate, indication of the appropriate methods of resterilization.

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

In case the products must be sterilized before use, the cleaning and sterilisation instructions must be formulated so that if they are properly followed, the product will continue to meet the requirements of the Article 6 of this Royal Decree.

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

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

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

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

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

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

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

(o) The medicinal products included in the product as an integral part of the product in accordance with paragraph 1.4.

p) The degree of accuracy attributed to measurement products.

ANNEX II

EC Declaration of Compliance

(Full Quality Assurance System)

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

2. The declaration of conformity is the procedure whereby the manufacturer who fulfils the obligations of paragraph 1 ensures and declares that the products in question conform to the provisions of this Royal Decree which are applicable.

The manufacturer shall affix the CE marking in accordance with Article 7 and make a written declaration of conformity. This declaration shall cover a given number of products manufactured, and the manufacturer shall keep it.

3. Quality system.

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

This request must contain:

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

(b) All relevant information on the products or category of products covered by the procedure.

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

d) The documentation relating to the quality system.

e) A commitment by the manufacturer to meet the obligations arising from the approved quality system.

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

g) A commitment by the manufacturer to establish and maintain an updated systematic procedure to review the experience gained with products in the post-production phase and to use the means appropriate to implement the necessary corrective measures. The undertaking shall include the obligation, on the part of the manufacturer, to inform the competent authorities of the following facts as soon as they are aware of the following: 1. any malfunction or alteration of the characteristics or benefits, as well as any inadequacy of the labelling or instructions for use of a product which may give rise to or may have resulted in the death or serious alteration of the health status of a patient or of a user; 2. any technical or sanitary reason linked to the characteristics or the the performance of a product for the reasons set out in paragraph 1 above, which has led the manufacturer to systematically withdraw products belonging to the same type.

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

In particular, you must contain an appropriate description of:

a) The quality objectives of the manufacturer.

b) The organization of the company, in particular: the organizational structures, the responsibilities of the managers and their organizational authority on the quality of the design and the manufacture of the products, the methods to monitor the effective functioning of the quality system and, in particular, its ability to give rise to the desired level of design and product quality, including the control of non-compliant products.

(c) The procedures for the control and verification of the design of the products, and in particular: a general description of the product, including the variants envisaged; the design specifications, including the applicable standards; and the results of the risk analysis, as well as the description of the solutions adopted to ensure compliance with the essential requirements for products where the standards referred to in Article 11 are not fully applied; control and verification techniques of design, procedures and systematic measures to be applied at the design stage of the products; where the product has to be connected to another product or other products in order to be able to function in accordance with its intended purpose, the proof that the product complies with the essential requirements connected to any of those products having the characteristics specified by the manufacturer; a statement indicating whether the product contains, as an integral part, a substance referred to in paragraph 1.4 of Annex I; and the data from the tests carried out in this respect; the clinical data referred to in Annex X, the model label and, where applicable, instructions for use.

(d) Quality assurance and control techniques in the manufacture and, in particular: processes and procedures, to be used, in particular in the field of sterilisation and purchase, and relevant documents, the product identification procedures adopted and updated, on the basis of drawings, specifications or other relevant documents, throughout all stages of manufacture.

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

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 give the conformity with those requirements if the quality systems comply with the relevant harmonised standards.

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

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

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

4. Examination of the design of the product.

1. The manufacturer, in addition to the obligations relating to him in accordance with paragraph 3, shall submit to the notified body an application for examination of the design dossier for the product to be manufactured and which forms part of the referred to in paragraph 3.1.

2. The application shall describe the design, manufacture and performance of the medical device concerned and shall include the necessary documents referred to in paragraph 3.2 (c) which allow the conformity with the requirements of the Directive to be judged. Royal Decree.

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

In the case of the products referred to in paragraph 1.4 of Annex I and as regards the aspects referred to in that paragraph, the notified body shall consult one of the competent bodies established by the Member States in accordance with Directive 65 /65/EEC before taking a decision.

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.

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

5. Control.

1. The purpose of the control is to ensure that the manufacturer complies with the obligations arising from the approved quality system.

2. The manufacturer shall authorise the notified body to carry out all the necessary inspections and shall provide it with all relevant information, in particular: the documentation relating to the quality system; the data provided for in the quality system relating to design, such as the results of analysis, calculations, tests, etc.; the data provided for in the part of the quality system relating to manufacturing, such as the reports for the inspections, tests, calibrations, qualification of the staff concerned, etc.

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

6. Administrative provisions.

1. The manufacturer shall have at the disposal of the competent authorities for at least five years from the last date of manufacture of the product: the declaration of conformity, the documentation referred to in the fourth indent of paragraph 3.1. amendments referred to in paragraph 3.4, the documentation referred to in paragraph 4.2, and the decisions and reports of the notified body referred to in paragraphs 3.3, 4.3, 4.4, 5.3 and 5.4.

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

3. With regard to products subject to the procedure laid down in paragraph 4 above, in cases where neither the manufacturer nor his authorised representative is established within the territory of the Community, the obligation to provide the technical documentation shall lie with the person responsible for placing the product on the market in the Community territory of the product or the importer referred to in paragraph 7.3 (a) of Annex I.

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

This Annex may be applied, in accordance with Article 8 (2) and (3), to the products of classes IIb and IIa. However, in the case of products of classes IIa and IIb, the provisions of paragraph 4 shall not apply.

ANNEX III

EC type examination

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

2. The application shall include: the name and address of the manufacturer, and the name and address of the representative in the event of the person submitting the application; the documentation referred to in paragraph 3, which is necessary for the assessment of the conformity of the representative sample of the production concerned, hereinafter referred to as 'type', with the requirements of this provision. The applicant shall make a 'type' available to the notified body. The notified body may request other copies if necessary; a written declaration specifying that no application concerning the same type has been submitted to another notified body.

3. The documentation shall enable the design, manufacture and performance of the product to be understood. The documentation shall include, in particular, the following elements: a general description of the type, including the variants envisaged; design drawings, intended manufacturing methods, in particular in the field of sterilisation; of components, subassemblies, circuits, etc.; the descriptions and explanations necessary for the understanding of the drawings and schemes mentioned and the operation of the product; a list of the rules referred to in Article 11, applied in whole or in part, as well as the description of the solutions adopted to comply the essential requirements where the standards referred to in Article 11 are not fully applied; the results of the design calculations, risk analysis, investigations, technical tests, etc., which have been carried out; the indication of whether the the product incorporates or does not, as an integral part, a substance as referred to in Annex I, paragraph 1.4, and the data relating to the tests carried out in this respect; the clinical data referred to in Annex X, if appropriate, the label project and, their case, of instructions for use.

4. The notified body:

1. It shall examine and evaluate the documentation and verify that the type has been manufactured in accordance with it; it shall also identify the elements which have been designed in accordance with the applicable provisions of the rules referred to in Article 11; as well as the elements whose design is not based on the relevant provisions of those rules.

2. Carry out or carry out appropriate checks and tests to check whether the solutions adopted by the manufacturer meet the essential requirements of this provision, where the standards referred to in this Regulation are not applied. Article 11; where a product is to be connected to another product or products in order to function in accordance with its intended purpose, it must be proved that the first product meets the essential requirements when it is connected to the products it has the characteristics indicated by the manufacturer.

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

4. It shall agree with the applicant where the necessary checks and tests are to be carried out.

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

In the case of the products referred to in paragraph 1.4 of Annex I and as regards the aspects referred to in that paragraph, the notified body shall consult one of the competent bodies established by the Member States in accordance with Directive 65 /65/EEC before taking a decision.

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.

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

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

7. Administrative provisions:

1. Each notified body shall make available to the other notified bodies, at its request, the relevant information on the EC type-examination certificates and the corresponding appendices which it has issued, which is not and retired.

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

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

4. In cases where neither the manufacturer nor his representative is established within the territory of the Community, the obligation to provide the technical documentation shall lie with the person responsible for placing on the market on the Community market of the the product or importer referred to in paragraph (a) of paragraph 7.3 of Annex I.

ANNEX IV

CE Verification

1. EC verification is the procedure whereby the manufacturer or his authorised representative established in the Community ensures and declares that the products referred to in paragraph 4 are in conformity with the type described in the EC examination certificate of type and meet the requirements of this Royal Decree that apply to you.

2. The manufacturer shall take the necessary measures to ensure that the manufacturing process ensures the conformity of the products with the type described in the EC type-examination certificate and with the requirements of this Royal Decree applicable. Prior to the start of manufacture, a documentation shall be drawn up in which the manufacturing processes are defined, in particular, where appropriate, as regards sterilisation, as well as the set of pre-established provisions and (a) systematic application to ensure the homogeneity of production and, where appropriate, the conformity of the products with the type described in the EC type-examination certificate and with the requirements of this Royal Decree to be applied to them applicable. It shall affix the CE marking in accordance with Article 7 and make a declaration of conformity.

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

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

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

2. No reason of a technical or sanitary nature linked to the characteristics or performance of a product for the reasons set out in the previous paragraph 1. products belonging to the same type.

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

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

5. Verification by control and testing of each product.

1. All products shall be individually examined and appropriate tests, as defined in the applicable standard or standards referred to in Article 11 or equivalent tests, shall be carried out in order to verify their conformity, where appropriate, with the type described in the EC type examination certificate and with the requirements of this Royal Decree which apply to them.

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

6. Statistical verification.

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

2. A random sample shall be taken from each batch. The products constituting the sample shall be individually examined and, in order to verify their conformity, where appropriate, with the type described in the EC type-examination certificate and with the applicable requirements of the Royal Decree, the relevant tests as defined in the applicable standard or standards referred to in Article 11 or equivalent tests in order to determine the acceptance or rejection of the lot.

3. The statistical control of the products shall be based on their properties, which shall mean a sampling plan which ensures a limit quality corresponding to a probability of acceptance of 5 per 100 with a percentage of non-conformity understood between 3 and 7 per 100. The sampling method shall be determined in accordance with the harmonised standards referred to in Article 11, taking into account the specificity of the product categories concerned.

4. If a lot is accepted, the notified body shall place or make its identification number on each product and shall extend a written certificate of conformity for the tests carried out. All products in the lot may be placed on the market, with the exception of non-compliant products.

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

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

7. Administrative provisions.

The manufacturer, or his representative, shall be available to the competent authorities for at least five years from the last date of manufacture of the product: the declaration of conformity, the documentation referred to in Paragraph 2, the certificates referred to in paragraphs 5.2 and 6.4, where appropriate, the type-examination certificate referred to in Annex III.

8. Application to products of Class IIa.

This Annex may be applied, in accordance with Article 8 (1.3), to products of Class IIa with the following exceptions:

1. By way of derogation from paragraphs 1 and 2, the manufacturer shall ensure and declare by means of the declaration of conformity that the products of Class IIa are manufactured in accordance with the technical documentation referred to in paragraph 3 of Annex VII and comply with the requirements of this Royal Decree which apply to them.

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

ANNEX V

EC Declaration of Compliance

(Production Quality Assurance)

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

2. 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 are in conformity with the the provisions of this Royal Decree which apply to them.

The manufacturer shall affix the CE marking in accordance with Article 7 and make a written declaration of conformity. The manufacturer shall keep this declaration, which shall relate to a number of identified specimens of manufactured products.

3. Quality system.

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

This request must contain:

a) The name and address of the manufacturer.

(b) All relevant information on the products or categories of products covered by the procedure.

(c) A written declaration specifying that no application has been submitted to another notified body concerning the same products.

d) The documentation relating to the quality system.

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

f) A commitment to maintain the approved quality system in such a way as to ensure its adequacy and effectiveness.

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

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

1. Any defective operation or alteration of the characteristics and/or performance, as well as any inadequacy of the labelling or instructions for use of a product which may give rise to or have been place of death or serious alteration of the health status of a patient or a user.

2. No reason of a technical or sanitary nature linked to the characteristics or performance of a product for the reasons set out in the previous paragraph 1. products belonging to the same type.

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 quality of the policy and the quality procedures, such as the quality programmes, plans, manuals and records.

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

a) The quality objectives of the manufacturer.

b) The organization of the company and in particular:

1. The organizational structures, the responsibilities of the managers and their authority to the organization regarding the manufacture of the

products.

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

(c) Quality assurance and control techniques in the manufacturing process and, in particular: processes and procedures to be used in relation to, in particular, sterilisation, procurement and documents relevant; of the product identification procedures established and updated, on the basis of 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 are to be carried out and the test equipment used; the calibration of the test equipment must be such that can be properly checked.

3. 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 give the conformity with those requirements if the quality systems comply with the relevant harmonised standards.

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

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

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

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

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

4. Control.

1. The purpose of the control is to ensure that the manufacturer of the obligations arising from the approved quality system is properly complied with.

2. The manufacturer shall authorise the notified body to carry out all necessary inspections and shall provide it with all relevant information, in particular: the documentation on the quality system; the data provided for in the part of the system of quality relating to manufacturing, such as the reports concerning inspections, tests, calibrations, the qualification of the staff concerned, etc.

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

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

5. Administrative provisions.

1. The manufacturer shall have at the disposal of the competent authorities for at least five years from the last date of manufacture of the product: the declaration of conformity, the documentation referred to in paragraph 3.1 (d), the adaptations referred to in paragraph 3.4, the documentation referred to in paragraph 3.1 (g), the decisions and reports of the notified body referred to in paragraphs 4.3 and 4.4, where appropriate, the type-examination certificate referred to in Annex III.

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

6. Application to products of Class IIa.

This Annex may be applied, in accordance with Article 8 (1.3), to products of Class IIa with the following exception:

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

ANNEX VI

EC Declaration of Compliance

(Product Quality Assurance)

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

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

2. The 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 are in conformity with the the provisions of the Royal Decree which apply to them.

The manufacturer shall affix the CE marking in accordance with Article 7 and make a written declaration of conformity. The manufacturer shall keep this declaration, which shall relate to a number of identified specimens of manufactured products. The CE marking shall be accompanied by the identification number of the notified body performing the functions referred to in this Annex.

3. Quality system.

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

This request must contain:

(a) The name and address of the manufacturer.

(b) All relevant information on the products or category of products covered by the procedure.

(c) A written statement specifying that no application has been submitted to another notified body concerning the same products.

d) The documentation relating to the quality system.

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

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

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

h) The manufacturer's commitment to establish and maintain a systematic procedure to review the experience acquired with the products in the post-production phase and to use the appropriate means to apply the necessary corrective measures. The undertaking shall include the obligation, on the part of the manufacturer, to inform the competent authorities of the following facts as soon as they are aware of the following:

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

2. No reason of a technical or sanitary nature linked to the characteristics or performance of a product for the reasons set out in the previous paragraph 1. products belonging to the same type.

2. In accordance with the quality system, each product or representative sample of each batch shall be examined and the appropriate tests defined in the relevant standard or standards referred to in Article 11, or equivalent tests, shall be carried out with the purpose of ensuring compliance with the type described in the EC type-examination certificate and with the applicable requirements of this Royal Decree. All the elements, requirements and provisions adopted by the manufacturer shall appear in a systematic and orderly documentation in the form of written measures, procedures and instructions. This documentation on the quality system will allow for a uniform interpretation of quality programmes, plans, manuals and dossiers. In particular, it shall include an appropriate description of: the quality objectives, the organisational structure, the responsibilities of the managers and their powers as regards the quality of the products; the checks and tests to be carried out after manufacture; the calibration of the test equipment must be such that it can be adequately checked; the means to verify the effective functioning of the quality system; the quality records, such as the reports of inspection and testing data, calibration data, reports on the qualification of the corresponding staff, etc.

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

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

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

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

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

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

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

4. Control.

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

2. The manufacturer shall authorise the notified body to access, in order to inspect them, the inspection, testing and storage facilities and shall provide it with all relevant information, in particular: the documentation on the system of quality; the technical documentation; the quality records, such as the reports concerning the inspections and the test data, the calibration data, the reports on the qualification of the staff concerned, etc.

3. The notified body shall carry out regular inspections and assessments in order to ensure that the quality system is applied by the manufacturer and shall provide an assessment report to the manufacturer.

4. The notified body may also visit without notice to the manufacturer. On the occasion of such visits, the notified body may, if it considers it necessary, carry out or have tests carried out to verify the proper functioning of the quality system and the conformity of production with the requirements of the Royal Decree that applies to you. To this end, a suitable sample of finished products, taken on site by the notified body, shall be checked and the appropriate tests defined in the applicable standard or standards referred to in Article 11 or equivalent tests shall be carried out. Where one or more copies of the controlled products are not in conformity, the notified body shall take appropriate measures.

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

5. Administrative provisions.

1. The manufacturer shall have at the disposal of the competent authorities for at least five years from the last date of manufacture of the product: the declaration of conformity, the documentation referred to in paragraph 3.1 (g), the adaptations referred to in paragraph 3.4, the decisions and reports of the notified body referred to in the last subparagraph of paragraph 3.4 and in paragraphs 4.3 and 4.4, where appropriate, the certificate of conformity referred to in Annex III.

2. The body shall make available to the other notified bodies and to the competent authority, at their request, the relevant information concerning the approvals of the quality system issued, refused and withdrawn.

6. Application to products of Class IIa.

This Annex may be applied, in accordance with Article 8 (1.3), to products of Class IIa with the following exceptions:

By way of derogation from paragraphs 2, 3.1 and 3.2, the manufacturer shall ensure and declare, by means of the declaration of conformity, that the products of Class IIa are manufactured in accordance with the technical documentation provided for in the Paragraph 3 of Annex VII and respond to the requirements of this Royal Decree which apply to them.

ANNEX VII

EC Declaration of Compliance

1. The EC declaration of conformity is the procedure whereby the manufacturer or his authorised representative established in the Community complies with the obligations laid down in paragraph 2 and, in the case of sterile products and those having a function of measurement, those of paragraph 5, ensures and declares that the corresponding products comply with the provisions of this Royal Decree which are applicable to them.

2. The manufacturer shall prepare the technical documentation described in paragraph 3 below; the manufacturer or his authorised representative established within the Community shall keep this documentation, including the declaration of conformity, at the disposal of the authorities. for inspection purposes for at least five years from the date of manufacture of the last product.

Where neither the manufacturer nor his authorised representative is established in the Community, this obligation to keep the technical documentation available shall be the responsibility of the person (s) responsible for marketing the product on the Community market.

3. The technical documentation shall make it possible to assess the conformity of the product with the requirements of this provision and shall include, in particular: a general description of the product, including the intended variants; design, intended manufacturing methods, as well as schemes of the components, subassemblies, circuits, etc.; the descriptions and explanations necessary for the understanding of the drawings and schemes mentioned and the operation of the product; the results of the risk analysis, as well as a list of the standards referred to in the Article 11, applied in whole or in part, and a description of the solutions adopted to meet the essential requirements of the Royal Decree where the rules referred to in Article 11 are not fully applied; sterile, a description of the methods used, the results of the design calculations, the checks carried out, etc. Where a product has to be connected to another or other products in order to function in accordance with its intended purpose, proof must be provided that the first product complies with the essential requirements when it is connected to any of those products. products having the characteristics indicated by the manufacturer; the test reports and, where appropriate, the clinical data in accordance with Annex X; the labels and instructions for use.

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

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

2. No reason of a technical or sanitary nature linked to the characteristics or performance of a product for the reasons set out in the previous paragraph 1. products belonging to the same type.

5. For products placed on the market in sterility and for products with a measurement function of Class I, the manufacturer shall, in addition to the provisions of this Annex, follow one of the procedures laid down in the Annexes IV, V or VI. The application of the abovementioned Annexes and the intervention of the notified body shall be limited: in the case of products placed on the market under sterility conditions, only those aspects of the manufacture which relate to obtaining and maintaining the conditions of sterility; in the case of products with a measurement function, only aspects of the manufacture relating to the conformity of the products with the metrological requirements.

Paragraph 6.1 of this Annex shall apply.

6. Application to products of Class IIa.

This Annex may be applied, in accordance with Article 8 (1.3), to products of Class IIa with the following exception:

When this Annex is applied in combination with the procedure referred to in Annexes IV, V or VI, the declaration of conformity referred to in paragraph 1 of this Annex and the declaration referred to in the other Annexes constitute a single declaration. As regards the declaration based on this Annex, the manufacturer shall ensure and declare that the design of the product complies with the provisions of this Royal Decree which apply to it.

ANNEX VIII

Statement regarding products that have a special purpose

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

2. The declaration shall contain the following

:

1. For custom products:

(a) Data to identify the product in question.

b) The claim that the product is intended to be used exclusively by a particular patient, and the name of that patient.

(c) The name of the doctor or authorised person who has made the corresponding prescription and, where appropriate, the name of the health centre.

d) The specific characteristics of the product indicated in the corresponding medical prescription.

(e) The declaration that the product concerned complies with the essential requirements set out in Article 6 and Annex I to this Royal Decree and, where appropriate, the indication of the essential requirements which have not been fulfilled completely, indicating the reasons.

2. For products intended for clinical research referred to in Annex X.

a) The approval of the conduct of the trial by a duly accredited Clinical Research Ethics Committee.

(b) The approval of the address of the centre in which the test shall be carried out.

(c) Data to identify the product in question.

(d) The research programme, including, in particular, the object, scientific, technical or medical justification, the scope and the number of the products concerned.

e) Name of the physician and the institution responsible for the investigations.

(f) Place, date of commencement and expected duration of the investigations.

g) The data shown in the preceding paragraphs shall be contained in a protocol, the document setting out the reason for the study, its objectives, design, methodology and the intended analysis of its results, as well as the conditions under which the test will be performed and developed.

Any clinical trial protocol should be written in Spanish and include the following basic sections:

1.

2.

3. General Information.

4. Data on pre-clinical manufacturing and evaluation of the product.

5. Justification and objectives.

6. Type of clinical trial and design of the same.

7. Selection of subjects.

8. Description of the treatment or procedure of use of the medical device, as appropriate.

9. Development of the test and evaluation of the response.

10. Adverse event.

11. Ethical aspects. Informed consent of the patient. 12. Practical considerations.

13. Statistical analysis.

h) The statement that the product concerned complies with the essential requirements, with the exception of the aspects covered by the investigation and, as far as the latter are concerned, declare that all precautions have been taken necessary to protect the health and safety of the patient.

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

1. With regard to custom-made products, the documentation enabling the design, manufacture and performance of the product, including the intended performance, to be understood in such a way as to assess its conformity with the requirements of the present Royal Decree.

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 the first subparagraph.

2. For products intended for clinical research, the documentation shall include: a general description of the product; design drawings, intended manufacturing methods, especially in the field of sterilisation; and components, subassemblies, circuits, etc.; descriptions and explanations necessary for the understanding of the drawings and schemes mentioned and the operation of the product; the results of the risk analysis, as well as a list of the rules referred to in Article 11, applied in whole or in part, and a description of the solutions adopted to meet the essential requirements of this provision, where the standards referred to in Article 11 are not applied, the results of the design calculations, the checks and the technical tests carried out, etc. The manufacturer shall take all necessary measures to ensure that the manufacturing process ensures the conformity of the products manufactured with the documentation referred to in the first subparagraph of paragraph 3.1. The manufacturer shall authorise the assessment or, where appropriate, the verification of the effectiveness of these measures.

4. The information given in the declarations referred to in this Annex shall be kept for a period of at least five years.

ANNEX IX

Classification Criteria

I. Definitions

Definitions in relation to the classification rules.

1. Duration.

Passenger use: normally intended for continuous use for less than sixty minutes.

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

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

2. Invasive products.

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

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

Invasive product of a surgical type: an invasive product that penetrates the inside of the body through the body surface by means of a surgical intervention or in the context of a surgical intervention.

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

Implantable product: any product designed: to be fully implanted in the human body, or to replace an epithelial surface or the ocular surface, by surgical intervention and intended to remain there after the intervention.

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

3. Reusable surgical instrument.

An instrument intended for surgical purposes for cutting, drilling, sawing, scaring, scraping, pinching, retracting, trimming or other similar processes, without being connected to any active medical device, and which may return to be used after all relevant procedures have been carried out.

4. Active medical device.

Any medical device whose operation depends on a source of electrical energy or any source of energy other than that generated directly by the human body or by gravity, and acting by conversion of that energy. Medical devices intended to transmit, without any significant modification, energy, substances or other elements of an active medical device to the patient shall not be considered as active medical devices.

5. Therapeutic active product.

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

6. Active product for diagnosis.

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

7. Central circulatory system.

In the framework of this Royal Decree, the following vessels are defined as the "central circulatory system": pulmonary arteries, ascending aorta, coronary arteries, primitive carotid artery, external carotid artery, artery internal carotid, cerebral arteries, brachiocephalic trunk, coronary veins, pulmonary veins, superior vena cava, inferior vena cava.

8. Central nervous system.

In the framework of this Royal Decree, the "central nervous system" means the brain, the meninges and the spinal cord.

II. Development standards

1. The application of the classification rules shall be governed by the intended purpose of the products.

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

3. Computer media used to operate a product or which have an influence on its use shall be automatically included in the same category.

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

5. If, for the same product, several rules apply, taking into account the performance of the manufacturer, the rules that lead to the highest classification shall apply.

III. Classification

1. Non-invasive products.

1. º Rule 1.

All non-invasive products shall be included in Class I, unless any of the following rules apply.

2. º Rule 2.

All non-invasive products intended for the conduction or storage of blood, fluids or body tissues, liquids or gases intended for infusion, administration or introduction into the body shall enter Class IIa:

a) If they can connect to an active health product in class IIa or higher class.

(b) If they are intended to be used for the storage or channeling of blood or other fluids or for the storage of organs, parts of organs or body tissues.

All other cases will be included in class I.

3. º Rule 3.

All non-invasive products intended to modify the biological or chemical composition of the blood, other body fluids or other liquids intended to be introduced into the body shall be included in class IIb, unless the treatment consists of filtration, centrifugation or exchange of gases or heat, in which case they shall be included in Class IIa.

4. º Rule 4.

All non-invasive products that come into contact with injured skin:

(a) They shall be classified in Class I if they are intended to be used as a mechanical barrier, for compression or for the absorption of exudates.

(b) They shall be classified in Class IIb if they are primarily intended for use with wounds which have resulted in a breakdown of the dermis and can only be healed by second intention.

(c) shall be included in Class IIa in all other cases, including products intended primarily for action in the microenvironment of a wound.

2. Invasive products.

1. º Rule 5.

All invasive products in relation to body orifices, except for invasive surgical products, which are not intended to be connected to an active medical device:

(a) They shall be included in Class I if they are intended for a passenger use.

(b) They shall be included in class IIa if they are intended for short-term use, except if they are used in the oral cavity up to the pharynx, in the external ear canal to the eardrum or in a nasal cavity, in which case they will be included in the class I.

c) Included in class IIb if they are intended for prolonged use, unless they are used in the oral cavity up to the pharynx, in the external ear canal to the eardrum or in a nasal cavity, and cannot be absorbed by the mucous membrane, in which case they shall be included in Class IIa.

All invasive products in relation to body orifices, except for invasive surgical products intended to be connected to an active medical device of Class IIa or higher class, shall enter into Class IIa.

2. º Rule 6.

All invasive surgical-type products intended for passenger use shall enter Class IIa unless:

(a) Are specifically intended to diagnose, monitor, or correct a cardiac or central circulatory system by direct contact with these parts of the body, in which case they will be included in class III.

b) Be reusable surgical instruments, in which case they will be included in class I.

(c) They are intended to supply energy in the form of ionising radiation, in which case they shall be included in Class IIb.

(d) They are intended to have a biological effect or to be fully or in large part absorbed, in which case they shall be included in Class IIb.

e) Are intended for the administration of medicinal products by means of a supply system, if this is done in a potentially dangerous manner taking into account the mode of application, in which case they shall be included in Class IIb.

3. º Rule 7.

All invasive surgical-type products intended for short-term use shall be included in Class IIa unless they are intended to:

a) Specifically diagnose, monitor, or correct a cardiac or central circulatory system by direct contact with these parts of the body, in which case they will be included in class III; or

b) Use, specifically, in direct contact with the central nervous system, in which case they shall be included in class III; or

c) Supply energy in the form of ionising radiation, in which case they shall be included in class IIb; or

d) Exercise a biological effect or be absorbed, fully or in large part, in which case they will be included in class III; or

e) Experience chemical modifications in the body, except if the products are placed inside the teeth, or administer medication, in which case they will be included in class IIb.

4. º Rule 8.

All implantable products and invasive products for prolonged use of the surgical type shall be included in class IIb unless they are intended:

a) To be placed inside the teeth, in which case they will be included in Class IIa.

b) To be used in direct contact with the heart, central circulatory system or central nervous system, in which case they will be included in class III.

(c) To exercise a biological effect or to be fully or in large part absorbed, in which case they shall be included in Class III.

d) To undergo chemical modifications in the body, except if the products are placed inside the teeth, or to the administration of medicinal products, in which case they will be included in class III.

3. Additional rules applicable to active products.

1. º Rule 9.

All active therapeutic products intended for the administration or exchange of energy shall be included in Class IIa unless their characteristics are such that they can be used or exchanged with the human body. potentially hazardous, taking into account the nature, the density and the point of application of the energy, in which case they shall be included in Class IIb.

All active products intended to control the operation of the active therapeutic products of class IIb or intended to directly influence the operation of such products shall be included in class IIb.

2. º Rule 10.

All active products for diagnostic purposes will be included in class IIa:

(a) If they are intended to supply energy that is to be absorbed by the human body, excluding products whose function is the illumination of the patient's organism in the visible spectrum.

b) If they are intended to create an image of the in vivo distribution of radioactive drugs.

c) If they are intended to allow for a direct diagnosis or the monitoring of vital physiological processes unless they are specifically intended for the monitoring of vital physiological parameters, when the variations of these parameters, such as variations in cardiac function, respiration, CNS activity, may present an immediate danger to the life of the patient, in which case they will be included in class IIb.

Active products intended to emit ionising radiation and which are intended for radiology for diagnostic and therapeutic purposes, including products for the control or monitoring of such products, or which directly influence the operation of the same shall be included in Class IIb.

3. º Rule 11.

All active products intended to administer medicinal products, body fluids or other substances to the body, or to extract them, shall be included in Class IIa unless this is potentially done dangerous, taking into account the nature of the substances, the part of the body concerned and the mode of application, in which case they shall be included in Class IIb.

4. º Rule 12.

All other active products will be included in class I.

4. Special rules.

1. º Rule 13.

All products incorporating as an integral part a substance which, if used independently, could be considered as a medicinal product within the meaning of Article 1 of Directive 65 /65/EEC and which may exercise on the human body an action incidental to that of the products, shall be included in Class III.

2. º Rule 14.

All products used for contraception or for the prevention of the transmission of communicable diseases by sexual contact shall be considered as products of class IIb unless they are implantable products or Long-term invasive, in which case they shall be included in Class III.

3. º Rule 15.

All products specifically intended for use of disinfection, cleaning, rinsing or, where appropriate, hydration of contact lenses, shall be included in Class IIb.

All products specifically intended for disinfection of medical devices shall be included in Class IIa.

This rule shall not apply to products intended for the cleaning of medical devices other than contact lenses by physical action.

4. º Rule 16.

Non-active products specifically intended for the recording of diagnostic radiographic images shall be included in Class IIa.

5. º Rule 17.

All products made using animal tissues or derivatives thereof which have been processed into infeasible shall be included in Class III, except in cases where the products are intended to enter into contact only with intact skin.

5. Rule 18.

By way of derogation from other rules, blood bags shall be included in Class IIb.

ANNEX X

Clinical Assessment

1. General provisions.

1. As a general rule, the confirmation of compliance with the requirements relating to the characteristics and benefits referred to in Article 6 (1) and (2) of this provision under normal conditions of use of a product, as the assessment of undesirable side effects, they shall be based on clinical data, in particular in the case of implantable products and class III products. Taking into account, where appropriate, the relevant harmonised standards, the adequacy of clinical data shall be based on:

(a) Well in a compilation of the relevant scientific literature available at that time on the intended use of the product and the techniques to be applied, as well as, where appropriate, in a written report containing a critical assessment of such collection.

(b) Well in the results of all the clinical investigations carried out, including those carried out in accordance with paragraph 2.

2. All data shall be considered confidential in accordance with the provisions of Article 28.

2. Clinical investigations.

1. Objectives.

The objectives of the clinical investigations shall be to verify that, under normal conditions of use, the performance of the products is in conformity with those referred to in Article 6 (2); and undesirable side effects under normal conditions of use and assess whether these are risks in relation to the performance attributed to the product.

2. Ethical considerations.

Clinical research will be carried out in accordance with the Helsinki Declaration, adopted in 1964 by the 18th World Medical Assembly in Helsinki (Finland), as last amended by the 41st Assembly. World Medical in 1989 in Hong Kong. It is imperative that the spirit of the Declaration of Helsinki be applied to all the provisions on the protection of persons, and this in each of the stages of clinical research, from the first reflection on the need and the justification for the study until the publication of the results.

3. Methods.

(a) Clinical investigations shall be carried out according to an appropriate test plan corresponding to the state of the science and the technique of the moment, defined in such a way as to confirm or refute the claims of the manufacturer to the purpose of the product; these investigations shall include a sufficient number of observations to ensure the scientific validity of the findings.

(b) The procedures used to conduct the investigations shall be adapted to the product under consideration.

(c) Clinical investigations shall be carried out under conditions similar to the normal conditions of use of the product.

(d) All relevant characteristics, including those relating to safety, to the performance of the product and to the effects on the patient, shall be examined.

(e) All the unfavourable incidents specified in Article 25 shall be fully recorded and communicated to the competent authority.

(f) Investigations shall be conducted in an appropriate environment under the responsibility of a physician or other person possessing the qualifications and authorised for that purpose.

g) The doctor or authorised person shall have access to the technical and clinical data relating to the product.

(h) The written report, signed by the physician or the responsible person responsible, shall contain a critical evaluation of all data obtained during clinical investigations.

4. Samples.

(a) Samples of medical devices to be used in clinical trials shall be provided free of charge by the sponsor. In certain situations other forms of supply may be authorised.

All leftover samples will be returned to the promoter after the test is completed.

(b) The labels and manual instructions for the samples for use in clinical trials must be in the official Spanish language of the State and allow at any time the perfect identification of the products.

(c) The promoter shall keep in the main test file the manufacturing and control protocols for the batch of products manufactured for the clinical trial.

d) The Hospital Pharmacy Services will monitor the supply of the samples to be used in the clinical trial.

ANNEX XI

Minimum criteria to be observed for the designation of notified bodies

1. The notified body, its director and the staff responsible for carrying out the assessment and verification operations may not be the designer, the manufacturer, the supplier, the installer or the user of the products they control, or the representative of none of these persons. They may not intervene directly or as representatives in the design, construction, marketing or maintenance of these products. This does not preclude the possibility of exchange of technical information between the manufacturer and the body.

2. The body and the staff responsible for monitoring shall carry out the assessment and verification operations with the utmost professional integrity and with the required competence in the health products sector and must be free of all pressure and incitement, in particular economic order, which may influence their judgment or the results of the monitoring, in particular the pressures from persons or groups of persons interested in the results of the verifications.

When a notified body confides specific work to a subcontractor in relation to the observation and verification of facts, it must first ensure that the subcontractor complies with the provisions of the Royal Decree. and, in particular, this Annex. The notified body shall have at the disposal of the national authorities the relevant documents relating to the assessment of the competence of the subcontractor and the work carried out by the subcontractor in the field of this Royal Decree.

3. The notified body shall be capable of carrying out all the tasks assigned in one of the Annexes II to VI to the bodies of this type and for which it has been notified, irrespective of whether the tasks are carried out by the body. your own body or under your responsibility. In particular, it will have to have the staff and the necessary means to adequately fulfil the technical and administrative tasks linked to the implementation of the evaluations and verifications. You will also need to have access to the equipment to perform the required verifications.

4. The staff responsible for the checks must have: good vocational training for all the assessment and verification operations for which the body has been designated; a satisfactory knowledge of the requirements relating to the inspections carried out and a sufficient practice of such checks; the ability to draw up the certificates, minutes and reports which constitute the materialisation of the checks carried out.

5. The independence of the staff responsible for monitoring must be ensured. The remuneration of each staff member shall not depend on the number of checks carried out or on the result of such checks.

6. The body must take out civil liability insurance, unless such liability is covered by the State Administration, or the controls are carried out directly by public bodies.

7. The staff of the body responsible for checks shall be bound by the obligation of professional secrecy in relation to all that is known to them in the performance of their duties (except in relation to the competent administrative authorities of the Spanish State) within the scope of this Royal Decree or any provision of internal law adopted pursuant to it.

ANNEX XII

CE Conformity Marking

The CE conformity marking shall consist of the initials "CE" presented in the following form:

(IMAGE 1 OMITIDA)

If the marking is reduced or wide, the proportions indicated in the graduated scheme shown above must be maintained.

The different components of the CE marking must basically have the same vertical dimension, which cannot be less than 5 millimetres.

This minimum dimension requirement may not be met for small product cases.

ANNEX XIII

Market Put Communication Model

Communication on the market and/or service of the health product called

Directed to: The General Directorate of Pharmacy and Healthcare Products.

1. Data of the person making the communication.

Don (first and last name or social reason)

with DNI or passport number or CIF

nationality

address for notification purposes (street, number, postal code, location, country)

representing the company

with address or registered office (street, number, postal code, location, country)

phone (country-number code)

fax (country-number code)

as of (indicate what is applicable):/manufacturer//authorized representative/importer//distributor/other (specify)

communicates the placing on the market of the product indicated below.

2. Product data.

Name/s with which the product is marketed in Spain

Name/s with which the product is marketed outside of Spain (commercial name)

Product Type

Model

Short Description

Target

Class (indicate where applicable)/III//IIb/

Date of placing on the market and/or product service in Spain (day-month-year)

3. Manufacturer's data.

Social name or reason

Address or registered office (street, number, postal code, location, country)

Phone (country-number code)

Fax (country-number code)

Other manufacturing sites other than the consignment, if applicable (specify with identical data)

4. Data from the authorised representative in the European Union or from the person responsible for placing on the market. (Fill in only if the manufacturer is not established in the European Union.)

Authorized//Responsible Representative/

Social name or reason

Address or registered office (street, number, postal code, location, country)

Phone (country-number code)

Fax (country-number code)

5. Data from the distributors of the product in Spain. Case that they do not match the person making the communication. (Specify the following data for each vendor.)

Social name or reason

DNI or CIF

Address or registered office (street, number, postal code, location, country)

Phone (country-number code)

Fax (country-number code)

6. Details of the conformity assessment procedures applied (indicate the conformity assessment procedures).

Reported Procedure/Body

(identification number)

Annex II/

Annex III/

Annex IV/

Annex V/

Annex VI/

7. Labelling and instructions for use.

The person responsible for the communication of this product declares that the labelling and instructions for use with which the product is marketed in Spain:

a)//They are translation and faithful transposition of the labelling and instructions certified by the notified body number

(b)//They have been submitted to the notified body number and the Spanish version is included in the certification issued by that body.

8. Accompanying documentation (please indicate what is applicable). /Labelling and instructions certified by the notified body (always accompany). /Labelling and instructions with which the product is marketed in Spain (accompany only in case of response (a) in paragraph 7).

Place and date

Signer name and last name

Directed to: Ministry of Health and Consumer Affairs. Directorate-General for Pharmacy and Health Products.

Note: This information may also be provided in computer support.