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Royal Decree 1662 / 2000, Of 29 September, On "in Vitro" Diagnostic Health Products.

Original Language Title: Real Decreto 1662/2000, de 29 de septiembre, sobre productos sanitarios para diagnóstico "in vitro".

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TEXT

Law 14/1986, of 25 April, General of Health, attributes to the State Administration, in its Article 40.5, the regulation, authorization and registration or approval, as appropriate, of those products and sanitary articles which, by affecting the human being, may pose a risk to human health. 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 which must be approved, approved or certified by the State, because of their special risk or importance for the health.

Both Laws are developed by this Royal Decree.

The regulation of "in vitro" diagnostic medical devices has been carried out in the European Union by Directive 98 /79/EC of 27 October on "in vitro" diagnostic medical devices, with the aim of the elimination of obstacles to intra-Community trade, ensuring the free movement of products under the best conditions of safety and providing patients, users and other persons with a high level of protection Health and safety, as well as the performance qualities of the products initially assigned to the manufacturer.

Directive 98 /79/EC is a specific Directive within the meaning of Article 2 (2) of Directive 89 /336/EEC.

This Community regulation is incorporated into the national legal order by this Royal Decree, thus fulfilling the obligation laid down in Article 22.1 of the aforementioned Directive.

Moreover, in order to ensure overall consistency in the regulation on medical devices, this Royal Decree also amends Royal Decree 414/1996 of 1 March on medical devices, according to the amendments that Directive 98 /79/EC has introduced in Directive 93 /42/EEC, the content of which was incorporated into the national legal order by the said Royal Decree 414/1996.

In addition, amendments to Royal Decree 634/1993 of 3 May on active implantable medical devices have been introduced in this Royal Decree in respect of national measures that allow the carrying out of the duties. of the Health Administration.

Those medical devices whose use is derived from increased risk have been included in Annex II to this Royal Decree, which in turn is subdivided into two groups: A and B.

The conformity assessment of these products with the essential requirements that apply to them must be carried out by the so-called notified bodies, which are bodies designated by the administrations. national and notified to the Commission, which gives them an identification number which is published in the Official Journal of the European Communities.

In all other products, compliance with the essential requirements is carried out by the manufacturer under his sole responsibility.

There are different procedures for carrying out the conformity assessment that are set out in Annexes III to VII.

Directive 98 /79/EC states that in order to demonstrate the conformity of the diagnostic medical devices in vitro with the essential requirements and to enable compliance control, the reference is useful. to the harmonised standards developed by the European Committee for Standardisation (CEN) and the European Committee for Electrotechnical Standardisation (CENELEC) and, in certain cases, to the so-called common technical specifications.

These common technical specifications are drawn up by the public authorities and may be used in the assessment, including re-evaluation, of the operation of certain products used mainly in the security assessment of the supply of blood and organ donations.

This Royal Decree, in which the sectors concerned and the Interterritorial Council of the National Health System have been drawn up, are issued in accordance with the provisions of Article 149.1.10. Spanish, and pursuant to Articles 40.5 and 6; 95, 100 and 110 of Law 14/1986, of 25 April, General of Health, and in Articles 1.3, 2.1, 2.2, 8.12, additional third and final provision of Law 25/1990, of 20 December, of the Medication.

In its virtue, on the proposal of the Minister of Health and Consumer Affairs, after the approval of the Minister of Public Administration, in agreement with the Council of State and after deliberation by the Council of Ministers at its meeting on 29 March. September 2000,

DISPONGO:

CHAPTER I

General provisions

Article 1. Scope of application.

1. This Royal Decree lays down the conditions to be met by the 'in vitro' diagnostic medical devices and their accessories for placing on the market, putting into service and use, and the procedures for assessing the compliance that applies to them.

Also, conditions are determined for your supply for performance evaluation purposes.

In vitro diagnostic medical devices will receive an identical treatment to the latter. Both in vitro diagnostic medical devices and accessories shall be hereinafter referred to as 'the products'.

2. For the purposes of this Royal Decree, the calibrators and control materials cover all types of substance, material or article designed by the manufacturer to establish measurement relationships or to verify the performance characteristics of a product with respect to the use for which it is intended.

3. This Royal Decree does not affect the prescription of medical prescription for products for which the current legislation so provides.

Article 2. Exclusions.

1. This Royal Decree shall not apply to products intended to be used exclusively in a health institution or in premises situated in the immediate vicinity of the institution and which are manufactured in the same institution, provided that it does not cede to another legal entity.

2. Certified reference materials at international level and materials used in external quality assessment systems are outside the scope of this Royal Decree.

3. This provision shall not affect the application of the provisions contained in the following rules: Royal Decree 1836/1999 of 3 December approving the Regulation of Nuclear and Radiactive Facilities; Royal Decree 18/1991, On 30 December, on the installation and use of X-ray equipment for medical diagnosis purposes; Royal Decree 53/1992 of 24 January, on the approval of the Regulation on Health Protection against Lonising Radiations and Royal Decree 1132/1990 of 14 September 1990 laying down basic protective measures Radiation therapy for persons undergoing medical examination and treatment.

Nor will it affect the application of the rules for transposition of Council Directive 96 /29/EURATOM of 13 May laying down the basic rules for the protection of the health of workers and workers. population against the risks arising from ionising radiation.

Article 3. Definitions.

For the purposes of this Royal Decree, the following definitions shall

:

(a) Healthcare product: Any instrument, device, equipment, material or other article, including software necessary for its proper functioning, intended by the manufacturer to be used in human beings, alone or in association with others, for the purposes of: Diagnosis, prevention, control, treatment or relief of a disease; diagnosis, control, treatment, relief or compensation of injury or deficiency; research, substitution or modification of the anatomy or of a physiological process; regulation of the conception, and that not exercise the main action to be taken on the inside or on the surface of the human body by pharmacological, immunological or metabolic means, but to the function of which they can contribute such means.

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

Samples for samples shall be considered as "in vitro" diagnostic medical devices. For sample containers, the products are understood, whether in them the vacuum has been made or not, specifically intended by the manufacturer for direct containment and for the preservation of samples from the human body for examination. "in vitro" diagnosis.

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

c) Accessory: An article which, without being a medical device for "in vitro" diagnosis, is specifically intended by its manufacturer to be used in conjunction with a product for the latter to be used as a compliance with its intended purpose.

For the purposes of this definition, invasive products intended for the production of samples and products placed in direct contact with the human body for the collection of samples, in accordance with the Royal Decree 414/1996, shall not be considered as accessories for in vitro diagnostic medical devices.

d) Product for self-diagnosis: Any product intended by the manufacturer to be used for profane at home.

e) Product for performance evaluation: Any product intended by the manufacturer to be the subject of one or more evaluation studies of its operation in medical analysis laboratories or in other suitable locations outside of its own facilities.

Instruments, devices, equipment, materials or other articles, including software, intended to be used for research purposes without pursuing health objectives shall not be considered as products intended for evaluation of operation.

(f) Manufacturer: The natural or legal person responsible for the design, manufacture, packaging and labelling of a product with a view to placing it on the market in its own name, irrespective of whether these operations are carried out by the same person or 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 assembles, put up, treats, totally renews or labels one or more manufactured products previously or assign them a purpose as products 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) authorised representative: The natural or legal person established in the European Union, expressly designated by the manufacturer, acting in his place and to whom the authorities and bodies in the European Union may be addressed in place of the manufacturer as regards the obligations of the manufacturer under this Royal Decree.

(h) Expected finality: The use to which the product is intended according to the indications provided by the manufacturer on the labelling, the instructions for use and/or the advertising material.

(i) Marketing: The first making available, for consideration or free of charge, of a product which is not a product for performance assessment with a view to its distribution or use on the Community market, whether it is a new or fully renovated product.

j) Put into service: The phase in which a product, which is ready to be used on the Community market according to its intended purpose, is made available to the end user for the first time.

k) New product: a product shall be deemed to be new if: For the previous three years, no such product has been permanently on the Community market for the analyte in question or another parameter; or the procedure involves an analytical technology which, during the previous three years, has not been permanently used on the Community market in relation to a given analyte or other given parameter.

CHAPTER II

Sanitary guarantees for products

Article 4. 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.

To obtain these authorizations, the companies that develop such activities will request them from the Directorate General of Pharmacy and Health Products, which will study the documentation presented and will notify their resolution within three months from the date on which the application and the accompanying documentation have entered into any of the Records of the Ministry of Health and Consumer Affairs.

The Directorate-General for Pharmacy and Health Products will ask the health areas of the Government Delegations to report on the conditions under which companies develop the related activities in this section, (a) to provide for inspections of the facilities of such undertakings which are necessary. Since the requested report is decisive for the content of the decision to be taken, it shall suspend the period of the maximum period of three months of the procedure, for the time between the request for the report, which shall be communicate to the undertaking concerned, and its receipt, which shall also be communicated to it, and without the period of suspension of which may in any case exceed three months, all in accordance with Article 42.5.c) of Law 30/1992, of 26 November, the Legal Regime of Public Administrations and the Administrative Procedure Common, in the wording given to it by Law 4/1999, of January 13, of modification of that.

The report referred to in the preceding paragraph will not be requested when companies develop manufacturing, grouping, sterilization and storage activities in established facilities outside the Spanish territory.

In order to carry out the activities referred to in this paragraph, the companies will have a technical officer, entitled university, whose qualifications accredit an appropriate qualification according to the products they have to their position, who shall exercise the direct supervision of such activities.

2. 'In vitro' diagnostic medical devices and performance assessment products may be placed on the market and/or put into service only if they comply with the requirements laid down in this provision when they have been duly established. supplied, properly installed and maintained and used in accordance with their intended purpose, without compromising the safety or health of patients, users or, where appropriate, third parties.

3. Products manufactured in non-EU countries whose manufacturer has not designated an authorised representative established on the territory of the European Union may not be placed on the market in Spain.

4. At the time of entry into service in Spain of the products, the data and information contained in paragraphs 5.3, 7 and 8 of Annex I shall be provided to the user at least in the official Spanish language of the State, so that ensure the safe and correct use of the product and provide for a certain and objective information on the essential characteristics of an effective, truthful and sufficient information.

5. Products whose labelling or promotional material contains particulars or flags which are misleading, attribute functions which do not possess or provide expectations of assured success shall not be placed on the market. Nor can it attribute superfluous character to medical intervention or to undermine the usefulness of other diagnostic methods requiring professional intervention.

6. Only products that comply with the provisions of this Royal Decree and by qualified and duly trained professionals may be used in Spain, depending on the product concerned. The products must be used in accordance with the conditions laid down by the manufacturer. The products must be properly maintained in such a way as to ensure that, during the period of use, they retain the safety and performance provided by their manufacturer.

Article 5. Essential requirements.

1. The products must be designed and manufactured in such a way that, when used under the conditions and for the intended purposes, they do not directly or indirectly compromise the clinical status or safety of the patients, the safety or health of the patients. users or, where appropriate, other persons, or the security of the goods. Any risk that may be associated with its use shall be acceptable in relation to patient benefits and compatible with a high level of health and safety protection.

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

When selecting the most appropriate solutions, the manufacturer shall apply the following principles in the order indicated: Remove or reduce as much as possible the risks (intrinsically safe design and construction); appropriate, take appropriate protective measures against risks that cannot be eliminated; inform users of the residual risks due to the incomplete effectiveness of the protection measures taken.

3. The products shall be designed and constructed in such a way as to be suitable for the purposes referred to in Article 3, (b) or (c), and specified by the manufacturer, taking into account the generally recognised state of the art. They must present the services declared by the manufacturer, in particular, where appropriate, with regard to analytical sensitivity, diagnostic sensitivity, analytical specificity, diagnostic specificity, accuracy, repeatability, reproducibility, including the control of known relevant interference and the detection limits of the method.

The correlation of the values assigned to the calibrators or control materials shall be ensured by means of available reference measurement procedures or higher grade available reference materials.

4. The characteristics and benefits referred to in paragraphs 1 and 3 of this Article shall not be altered to such a degree as to endanger the health or safety of the patient, the user or, where appropriate, other persons when the product is subject to situations which may arise under normal conditions of use during the period of validity. The above shall apply to the period of validity reasonably expected of a product of the corresponding type, taking into account the intended purpose and the intended use of the product.

5. Products must be designed, manufactured and conditioned in such a way that their characteristics and performance during their intended use are not adversely affected by storage and transport conditions (temperature, humidity, etc.). indicated in the information and instructions provided by the manufacturer.

6. Products shall comply with the essential requirements set out in Annex I which apply to them, taking into account the intended purpose of the product concerned.

Article 6. CE conformity marking.

1. Only 'in vitro' diagnostic medical devices which bear the CE marking may be placed on the market and put into service. As an exception, the products for the performance assessment shall not bear the CE marking.

The CE marking may be affixed only to products which have demonstrated their conformity with the essential requirements referred to in Article 5 and which have followed the conformity assessment procedures identified in the Article 7.

2. The CE conformity marking, as set out in Annex X, must appear on the product in a visible, legible and indelible manner, provided that this is appropriate and possible, as well as in the instructions for use. The CE marking of conformity must also appear on the sales packages.

3. The CE marking shall be accompanied by the identification number of the notified body responsible for the application of the procedures laid down in Annexes IV, VI and VII and in paragraph 6 of Annex III

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

4. It shall be prohibited to place marks or inscriptions which may induce third parties to misinterpretation in relation to the meaning or graphics of the CE marking or which detract from the significance of the CE marking. The product, package or package leaflet accompanying the product may be placed on the product, provided that the visibility and legibility of the CE marking is not thereby reduced.

5. The CE conformity marking may also not be affixed, as provided for in this Royal Decree, in products not covered by the Royal Decree. In case of detection, such assumptions shall be treated, for all purposes, as "non-compliant products", the procedures provided for in this Royal Decree apply.

6. Where products are subject to other Community Directives or national provisions which have transposed them, in respect of other aspects which also provide for the affixing of the CE marking, the latter shall indicate that the products comply also the provisions of the other national Directives or provisions.

However, if one or more of these Directives or national provisions transposing them allow the manufacturer, during a transitional period, to choose which measures to apply, the CE marking shall indicate that the products comply with the only the provisions of the national Directives or provisions applied by the manufacturer. In this case, the references to these Directives, as published in the Official Journal of the European Communities, must be indicated in the documents, leaflets or instructions required by the Directives accompanying the Directives. such products.

Article 7. Conditions for affixing the CE marking.

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

The manufacturer may instruct his authorised representative to initiate the procedures provided for in Annexes III, V, VI and VIII. Both the manufacturer and the authorised representative, in the course of such procedures, are subject to the obligations laid down in the relevant Annexes.

1. For the products listed in Annex II A-list other than those intended for performance evaluation, the manufacturer, in order to affix the CE marking, may choose between:

(a) Follow the procedure relating to the EC declaration of conformity set out in Annex IV (total quality assurance system) or

(b) Follow the procedure concerning the EC type-examination set out in Annex V, together with the procedure concerning the EC declaration of conformity set out in Annex VII (quality assurance system for the production).

2. For the products listed in Annex II, list B, other than those intended for performance evaluation, the manufacturer, in order to affix the CE marking, may choose between:

(a) Follow the procedure relating to the EC declaration of conformity set out in Annex IV (total quality assurance system) or

(b) Follow the procedure relating to the EC type-examination set out in Annex V, together with: The procedure concerning the EC verification set out in Annex VI or the procedure relating to the EC declaration of conformity set out in Annex VII (production quality assurance system).

3. For self-diagnostic products, other than those referred to in Annex II and which are not intended for performance evaluation, the manufacturer shall comply with the additional requirements laid down in Annex III (6) and draw up the declaration of conformity referred to in this Annex. Instead of applying this procedure, the manufacturer may follow the procedures referred to in paragraph 1.1 and in paragraph 1.2 of this Article.

4. In the case of products for performance evaluation, the manufacturer shall follow the procedure referred to in Annex VIII and draw up the declaration set out in that Annex before supplying such products. It shall also comply with Article 9.

5. For products other than: Those covered by Annex II; products for performance evaluation and self-diagnostic products, the manufacturer, in order to affix the CE marking, shall follow the procedure referred to in Annex III and draw up the EC declaration of conformity required before the products are placed on the market. The Directorate-General for Pharmacy and Health Products shall, where appropriate, assess the documentation referred to in Annex III for the purpose of establishing the conformity of the products after they have been placed on the market and/or put into service.

2. During the procedure for assessing the conformity of a product, the manufacturer and, in the case of intervention, the notified body, shall take into account the results of any evaluation and verification operations carried out, in their case, in accordance with this Royal Decree at an intermediate stage of manufacture.

3. The manufacturer shall keep the declaration of conformity and the technical documentation referred to in Annexes III to VIII, as well as the decisions, reports and certificates from the notified bodies, and make them available to the competent authorities for control purposes over a period of five years from the manufacture of the last product. Where the manufacturer is not established in the European Union, the obligation to submit the said documentation when requested shall apply to his authorised representative.

4. Where the conformity assessment procedure involves the intervention of a notified body, the manufacturer or his authorised representative may address a body of his/her choice in the framework of the tasks for which the body has been notified.

5. Any natural or legal person who manufactures products falling within the scope of this Royal Decree and who, without being placed on the market, puts them into service and uses them in the context of their professional activity, must affix the marking EC to its products after having applied the conformity assessment procedures laid down in this Article which are applicable to them.

Article 8. 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 7 shall be considered to be in conformity with the essential requirements, with the exception of prima facie evidence.

2. Where the products comply with the relevant national rules adopted pursuant to 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. Products designed and manufactured in accordance with the common technical specifications drawn up for the products listed in Annex II, List A, and, where necessary, for the products listed in Annex II, list B, shall be presumed to comply with the requirements of Annex II. the essential requirements referred to in Article 5.

5. The specifications referred to above shall, in an appropriate manner, establish the criteria for the assessment and evaluation of the operation, the approval of lots, the reference methods and the reference materials.

6. In general terms, manufacturers must comply with the common technical specifications; if, for duly justified reasons, manufacturers do not comply with these specifications, they must adopt solutions of at least equivalent level. to these.

7. Where reference is made in this Royal Decree to harmonised standards, they shall also be considered as referring to the common technical specifications.

CHAPTER III

Marketing and commissioning

Article 9. Registration of responsible for marketing.

1. Any manufacturer established in Spain which markets products on its own behalf shall be included in the register of persons responsible for placing on the market, which shall exist in the General Directorate of Pharmacy and Sanitary Products. To this end, the interested parties shall make a communication to the Autonomous Community where the undertaking has its registered office, at the time when the first marketing of the product is effective. The Autonomous Community shall immediately forward the documentation to the Directorate-General for Pharmacy and Health Products.

Communications may be filed in any of the places provided for in Article 38.4 of Law 30/1992, of November 26, of the Legal Regime of Public Administrations and of the Common Administrative Procedure.

2. The communication shall contain, at least in the official Spanish language of the State, the following data:

a) Identification data of the person making the communication.

b) Manufacturer's name and social reason.

c) Address of the manufacturer's registered office.

d) 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.

e) Product type.

f) Technology features.

g) Expected product finality.

h) Indication of whether this is a new product under the terms of Article 3, k).

3. Where a manufacturer placing products on his own behalf has no registered office in a Member State of the European Union, he shall designate an authorised representative established in the European Union. Where the authorised representative is a natural or legal person established in Spain, the latter shall follow the procedure referred to in paragraphs 1 and 2 of this Article.

4. In the case of new products under the terms of Article 3 (k) of this Royal Decree, the Directorate-General for Pharmacy and Health Products may request the manufacturer, for two years following the communication to which he is refers to paragraph 1 of this Article and for justified reasons, a report on the experience acquired with the product after it has been placed on the market. That report shall be sent to the authorities of the Member States requesting it.

5. Any changes to the data referred to in paragraph 2 of this Article shall be communicated in accordance with the procedure laid down in this Article. The cessation of the marketing of the products shall also be communicated.

Article 10. Communication of placing on the market and putting into service.

1. Any person placing on the market or putting into service products listed in Annex II to this Royal Decree or products for self-diagnosis shall direct a communication to the Directorate-General for Pharmacy and Health Products at the time of make effective the first marketing or putting into service of the product in Spain.

In the case of "in vitro" diagnostic medical devices referred to in the preceding paragraph, which do not come from third countries, the communication may be made to the register establishing, where appropriate, the competent authority of the the Autonomous Community in which the first placing on the market or putting into service of the medical device is carried out. The competent authority of the Autonomous Community shall immediately forward the documentation to the Directorate-General for Pharmacy and Health Products.

Communications may be filed in any of the places provided for in Article 38.4 of Law 30/1992, of November 26, of the Legal Regime of Public Administrations and of the Common Administrative Procedure.

The General Directorate of Pharmacy and Health Products shall keep an updated record of Annex II products and self-diagnostic products with all communications referred to in the preceding paragraphs.

2. The communication shall contain at least, at least in the official Spanish language of the State, the following data:

a) Identification data of the person making the communication.

b) 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.

c) Product type.

d) Expected finality.

(e) Analytical and/or diagnostic parameters referred to in Article 5 (3) of this Royal Decree.

f) Results of the performance evaluation.

(g) Certificates issued by the notified body/s that have intervened in the conformity assessment for the purposes of affixing the CE marking.

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

i) Labelling and instructions for use presented to/certified by the notified body.

(j) Labelling and instructions for use with which the product is to be marketed in Spain when the version in the official Spanish language of the State is not included in the information referred to in paragraph (i).

In this case, the Spanish language version must be a faithful translation of those presented to/certified by the notified body

k) Date on which the product is marketed or put into service in Spain.

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

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

Article 11. Information to the Autonomous Communities.

The records provided for in Articles 9 and 10 shall be kept at the disposal of the competent authorities of the Autonomous Communities.

Article 12. European database.

The data resulting from the application of Article 9 of this Royal Decree shall be transferred by the Directorate-General for Pharmacy and Health Products, for registration, to the European database described in Article 12 of the Directive 98 /79/EC, using a standardised format for submission.

CHAPTER IV

Distribution and Selling

Article 13. 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) of paragraph 8.4 of Annex I.

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

3. Natural or legal persons engaged in the distribution or sale to the public of products covered by this Royal Decree shall inform the health authorities of the Autonomous Community where they are located. established by writing in which they record:

a) Identification of the distribution premises.

b) Types of products that you distribute.

(c) Identification of the technician provided for in Article 14 (4).

Except for such communication are those distributors who also possess the status of manufacturers or importers of the products, as well as the pharmacy offices.

4. The sale to the public of the products for self-diagnosis will be made exclusively through the pharmacy offices.

5. The street sale of "in vitro" diagnostic medical devices is prohibited.

Article 14. 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: Commercial name of the product, model, series and/or batch number, date of acquisition, date of shipment or supply and identification of the customer.

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 the procedures set out in Articles 10 and 20 of this Royal Decree, where applicable.

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

CHAPTER V

Community Transactions and Foreign Trade

Article 15. Community circulation and import.

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

Article 16. 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, in order to avoid its use in the Community market.

CHAPTER VI

Performances of public administrations

Article 17. Notified bodies.

1. The Ministry of Health and Consumer Affairs shall designate the bodies which shall carry out the procedures referred to in Article 7 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 State Gazette", together with the identification number assigned by the European 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 to be designated and carry out continuous monitoring to verify the maintenance of these skills in the the designated bodies.

2. Notified bodies shall comply with the requirements set out in Annex IX. It shall be presumed that the bodies which meet the criteria laid down in the national rules transposing the relevant harmonised standards 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 IX, the Ministry of Health and Consumer Affairs shall withdraw the authorisation or limit its scope, subject to the appropriate procedure. (a) administrative, with a hearing of the person concerned, and shall inform the European Commission and the other Member States thereof.

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 18. 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 European Union shall establish by common agreement the time limits for the completion of the procedures for the assessment and verification of compliance with the products.

The documentation for these evaluation procedures will be written, at least in the official Spanish language of the State. However, the notified body may accept the submission in another language of scientific or specialised documentation which supports part of the conformity assessment.

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

3. In the assessment of the conformity of a product, the notified body shall take into account any relevant information concerning the characteristics and operation of the products, including in particular the results of all tests and appropriate verifications already carried out in accordance with the national legislation in force on 7 December 1998, in any country of the European Union.

4. Decisions taken by the notified bodies in accordance with Annexes III, IV and V shall be valid for a maximum of five years and may be extended, upon request made at the time agreed in the contract signed by both parties, by successive periods of up to five years.

5. Where a notified body finds that the manufacturer does not comply with or no longer complies with the relevant requirements of this Royal Decree, or that a certificate has not been issued, it shall suspend or withdraw the certificate issued, bearing in mind the principle of proportionality, unless the manufacturer ensures compliance with those requirements by implementing effective corrective measures. In cases of suspension or withdrawal of the certificate, or in cases where restrictions are placed, or where the intervention of the competent authority may be required, the notified body shall inform the Directorate-General of the facts. General of Pharmacy and Sanitary Products moving a copy of the corresponding decision. The Directorate-General for Pharmacy and Health Products shall inform the other Member States and the Commission and keep the Autonomous Communities informed of the suspended or withdrawn certificates.

6. The notified body shall inform the other notified bodies and the competent authorities of all the suspended or withdrawn certificates, as well as of the certificates issued or refused, on request. In addition, upon request, all relevant additional information shall be made available to you.

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

8. Against the decisions taken by the notified body, in accordance with paragraph 5 of this Article, the person concerned may express his disagreement with the body itself and, in the event of the disagreement, before 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. Such a decision may be brought directly to the administrative or administrative proceedings or, as provided for in Articles 116 and 117 of Law No 30/1992 of 26 November 1992, to be brought before the Court of Justice for a period of one month. Legal status of public administrations and the common administrative procedure.

Article 19. 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, by itself or through the inspection services of the General Administration of the State authorized for these purposes, may carry out inspection and control activities in respect of the products referred to in Chapter V and the establishments in which they are manufactured, imported or exported, provided that they are located on national territory.

3. The staff at the service of the public administrations carrying out inspection duties shall proceed as provided for in Article 105 (3) of Law 25/1990 of 20 December of the Medicament, 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 subject to performance evaluation.

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 20. Surveillance system.

1. Where, on the occasion of their activity, the health professionals, the inspection authorities, the manufacturers, the officials of the products or the centres which carry out programmes of external quality assessment, warn of any dysfunction, alteration of the characteristics or performance of a product, as well as any inadequacy of the labelling or instructions for use which, directly or indirectly, may or may have resulted in the death or serious deterioration of the state The health of a patient, a user or other persons, must be communicated to the General 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 or his authorised representative shall be informed of the 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 medical reasons in relation to the characteristics or operation of a product related to any of the circumstances mentioned in the previous paragraph.

3. After having carried out their assessment, the Directorate-General for Pharmacy and Health Products shall, if possible jointly with the manufacturer, inform the European Commission and the other Member States of the facts in respect of which they have been the possibility of taking appropriate action is considered or considered.

Article 21. Health protection measures.

1. If there are prima facie evidence concerning the non-conformity of a product, the health authorities may require the manufacturer or the authorised person in the European Union to submit the presentation in the official Spanish language of the State, of any information deemed necessary to judge on such compliance.

The refusal to provide the indicated documentation may be considered as a presumption of non-compliance.

2. As a guarantee of the health and safety of persons, the competent health authorities, when they consider that a product correctly put into service, installed, maintained and used in accordance with its intended purpose, may compromise the health and/or safety of patients, users or third persons or the safety of the goods, shall take the appropriate measures provided for in Chapter V of Title I of Law 14/1986 of 25 April, General of Health, and in the Chapter I of Title IX and Article 110 of Law 25/1990 of 20 December of the Medication.

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

3. 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 measure.

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

5. Where a non-compliant product has the CE marking, the competent health authorities shall take appropriate measures against those who have affixed the marking and shall inform the Directorate-General of Pharmacy and Health Products thereof. That management centre shall act accordingly and shall communicate it to the European Commission and the competent authorities of the other Member States.

6. 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 4.1, 4.4, 9 and 10 of this Royal Decree.

7. When, on the initiative of the manufacturer or distributor of the products, measures are agreed on prevention, warning or withdrawal of products from the market, as well as the dissemination of warnings related to diagnostic medical devices " in In vitro, they shall be brought to the attention of the competent health authorities prior to their commencement. Those authorities may suspend the implementation of the proposed measures, prevent them or amend them for justified reasons of public health.

8. 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.

9. Where the verification of the conformity of a product requires the performance of evaluations or tests on the product or its technical documentation, the costs resulting from such verification shall be satisfied by the manufacturer or his/her responsible, who also provide the necessary samples to perform such a check.

10. Where, by application of this Royal Decree, the placing on the market and/or putting into service of a product is rejected or restricted, and where the withdrawal of a product from the market takes place, the person concerned may express his disagreement. to the hierarchical superior body of which the decision was made, by means of the appropriate appeal within one month, in accordance with Articles 114 and 115 of the Law on the Legal Regime of the General Administration and the Common Administrative Procedure.

Article 22. Particular measures for health monitoring.

When the Directorate General of Pharmacy and Healthcare products considers, in respect of a particular product or group of products, that to ensure the protection of the health of the persons, the safety or the compliance of the public health rules within the meaning of Article 30 of the EC Treaty, the availability of such products must be prohibited, restricted or subject to special requirements, and all necessary transitional measures may be adopted; The Commission and the other Member States shall inform the Commission and the other Member States of the reasons for their decision.

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

Article 23. Express authorizations.

Upon justified request, the General Directorate of Pharmacy and Health Products may expressly and individually authorize, in the interest of health protection, the placing on the market, putting into service and use of products for which the conformity assessment procedures referred to in Article 7 of this Royal Decree have not been satisfied.

Article 24. 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 competent authorities and the notified bodies in respect of reciprocal information, the dissemination of warnings or the reporting obligations of the persons concerned, both before the authorities and before the courts.

CHAPTER VII

Advertising and exhibitions

Article 25. 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 healthcare 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 'in vitro' diagnostic medical device.

4. Where, by reason of the nature of the product, direct advertising is made to the public, account shall be taken, in particular, of the provisions of Article 4 (5) of this Royal Decree. Advertising and/or promotional messages addressed to the public of the products referred to in this Royal Decree shall be subject to prior authorisation by the health authorities of the Autonomous Communities.

5. In particular, the advertising or promotional texts shall reflect the accuracy of the data obtained with the use of the product, as well as the limitations, restrictions or warnings necessary for the products to achieve their purpose. expected.

6. The advertising of products addressed to the public and carried out by private individuals shall be prohibited any mention referring to a health authority or to recommendations made by scientists, health professionals or other persons. which may, due to their notoriety, incite their use.

7. In accordance with Article 27 of Law 14/1986, of 25 April, General of Health, advertising of any product which, without complying with the provisions of this Royal Decree, intends to carry out any of the intended purposes in the Article 3 (b) or 3 (c) of this Royal Decree.

Article 26. Incentives.

1. In the framework of the promotion of "in vitro" diagnostic medical devices, it is prohibited to grant, offer or promise premiums, pecuniary advantages or benefits in kind to healthcare professionals or any other person related to the health use, prescription or dispensing of products as well as their relatives and persons with whom they live.

2. Persons referred to in the previous paragraph may not request or accept any of the prohibited incentives.

Article 27. 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 clinical practitioners or the entities in which they are associated.

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

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

Article 28. 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 these products on samples from the participants.

CHAPTER VIII

Violations and penalties

Article 29. Violations.

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 marketing and/or service.

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

3. Failure to comply with the requirements, obligations or prohibitions set out in this Royal Decree which, by reason of the criteria referred to in this Article, merit the rating of minor or does not carry out its qualification as serious or very serious faults.

2. Serious breaches:

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

2. The failure to comply with a technical officer in accordance with Articles 4.1 and 14.4.

3. The use of any other marking which may lead to confusion with the CE marking or which detracts from its significance.

4. The failure to comply with the obligation to communicate the placing on the market or putting into service of the products, as well as the amendments to those communications, as set out in Article 10.

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 Article 7.3.

7. Do not carry out the communication set out in Article 9 of this provision.

8. ª Distribute and/or sell to the public health products for "in vitro" diagnosis in establishments that have not been properly communicated in accordance with Article 13.3.

9. Distribute, Install, Maintain And Use "in vitro" diagnostic medical devices without observing the required conditions, as well as to put on sale altered sanitary products, in poor conditions or when exceeded the validity period.

10. Prevent the performance of duly accredited inspectors in the centres where they are manufactured, stored, distributed or sold for "in vitro" diagnostic medical devices.

11. Failure to fulfil the obligation of communication provided for in Article 20 of this Royal Decree.

12. Failure to comply with the requirements relating to the advertising and promotion of medical devices, as well as the conditions laid down in Article 25.

13. The provision, grant or promise of premiums, pecuniary advantages or benefits in kind to healthcare professionals or any other qualified person, relating to the use, prescription or dispensing of products, as well as to their relatives and people with whom they live. Also requesting or accepting them.

14. The use by a professional of medical devices for "in vitro" diagnosis under conditions and for uses other than those indicated by the manufacturer, or by non-qualified or duly trained personnel, with a risk to the health and safety of people.

15. The putting into service in Spain of "in vitro" diagnostic medical devices without having provided the data contained in paragraphs 5.3, 7 and 8 of Annex I, at least in the official Spanish language of the State.

16. The misuse of the CE marking on non-conforming products or on the products referred to in Article 6 (5).

17. The sale to the public of self-diagnosis products in establishments other than pharmacy offices.

3. Very serious breaches:

1. The placing on the market and/or in service of "in vitro" diagnostic medical devices that compromise the health or safety of patients, users or, where appropriate, third parties.

2. The placing on the market and/or in service of the "in vitro" diagnostic medical devices that do not meet the essential requirements that apply to them, according to this Royal Decree.

3. The placing on the market and/or in service of "in vitro" diagnostic medical devices which have not satisfied the conformity assessment procedures or which have not made the declarations which, if necessary, application results.

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

5. Failure to comply with the obligation to implement the measures and actions provided for in Articles 14.3, 20, 21 and 22 of this Royal Decree.

6. The incorrect execution, by the notified body, of the actions entrusted to it in Article 18 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 24 of this Royal Decree.

Article 30. Penalties.

1. The actions and omissions constituting infringements, as provided for in Article 29 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 the imposition of penalties 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 and Royal Decree 1398/1993 of 4 August, for which the Regulation is adopted for the exercise of sanctioning powers.

2. The offences referred to in Article 29 of this Royal Decree shall be punishable by a fine in accordance with the graduation laid down in Article 36 of Law 14/1986 of 25 April 1986, 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 installations which do not have the necessary prior authorisations or health records, or the suspension of their operation until the defects are remedied, shall not be of a sanction. meet the requirements for health, hygiene or safety reasons.

Additional disposition first. Basic character.

1. They have the status of basic health standard, as set out in Articles 149.1. 16. of the Constitution, 1.3, 2.2 and 8.12 and additional provision third of Law 25/1990, of 20 December, of the Medicamento, and 40.5 and 6, 95, 100 and 110 of Law 14/1986, of 25 April, General of Health, all articles, provisions and annexes of this Royal Decree.

2. Article 15 on the import of products and Article 16 of this Royal Decree are issued under the terms of Article 149.1.10. and 16. of the Constitution.

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

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

Additional provision third. Tissues, cells and substances of human origin.

For the purposes of this Royal Decree, the taking, obtaining and use of tissues, cells and substances of human origin shall be governed by the principles laid down in the Council of Europe Convention. for the protection of human rights and the dignity of the human being with respect to the applications of biology and medicine and the legislation in force in this field. As for the diagnosis, the protection of the confidentiality of information concerning private life is paramount, as is the principle of non-discrimination based on the genetic characteristics of men and women. women.

Additional provision fourth. Procedures for the assessment of conformity.

The implementation of the conformity assessment procedures, as set out in Article 7 of this provision, will be independent of the certification which, in the field of industrial quality, is indicated in Law 21/1992, 16 of July, Industry.

Additional provision fifth. Application of fees.

The procedures referred to in Articles 4.1, 7.1, 10 and 18.1 shall apply to them the corresponding fees set out in Article 117 of Title X of Law 25/1990 of 20 December of the Medicament.

Additional provision sixth. Application of the electromagnetic compatibility legislation.

In vitro diagnostic medical devices, the conformity of which has been determined in accordance with this Royal Decree, does not apply to the Royal Decree 444/1994 of 11 March, establishing the procedures for the assessment of conformity and the protection requirements relating to the electromagnetic compatibility of equipment, systems and installations transposing Directive 89 /336/EEC.

Additional provision seventh. Amendments to Royal Decree 414/1996 of 1 March.

1. In accordance with Article 21 of Directive 98 /79/EC of 27 October, the following amendments are made to Royal Decree 414/1996 of 1 March for the regulation of medical devices:

A) Article 3. Definitions:

a) The text of paragraph (c) is replaced by:

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

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

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

(b) The text in paragraph (i) is replaced by:

"In service: the phase in which a product, which is ready to be used on the Community market according to its intended purpose, is made available to the end user for the first time."

c) The following paragraph is added:

" (k) authorised representative: any natural or legal person established in the European Union, expressly designated by the manufacturer, acting in his place and to whom the authorities and bodies in the Union may address European rather than the manufacturer as regards the obligations of the manufacturer under this Royal Decree. '

B) Article 5. General conditions:

The text in paragraph 2 is replaced by:

" Health products and bespoke products may only be placed on the market and/or put into service if they comply with the requirements laid down in this provision when they have been duly supplied, correctly installed and maintained and used in accordance with its intended purpose, without compromising the safety or health of patients, users or, where appropriate, third parties. "

C) The following items are added:

" (a) Article 15a. European database.

Regulatory data resulting from the application of Article 14 of this Royal Decree will be transferred by the Directorate General of Pharmacy and Health Products to the European database described in the Article 12 of Directive 98 /79/EC, using a standardised format for its submission. "

" (b) Article 26a. Particular measures for health monitoring.

When the Directorate General of Pharmacy and Healthcare products considers, with respect to a particular product or group of products, that to ensure the protection of human health, safety or compliance with public health rules within the meaning of Article 30 of the EC Treaty, the availability of such products must be prohibited, restricted or subject to special requirements, the necessary transitional measures may be adopted The Commission and the other Member States are required to inform the Commission and the other Member States of the reasons for your decision.

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

D) Article 23. Actions of the notified body:

(a) The text in paragraph 5 is replaced by:

" The notified body shall inform the other notified bodies and the competent authorities of all the suspended or withdrawn certificates and, on request, of the certificates issued or refused. In addition, upon request, all relevant additional information shall be made available to it. "

(b) The text in paragraph 6 is replaced by:

" In the event that a notified body finds that the manufacturer does not comply with or no longer complies with the relevant requirements of this Royal Decree, or that a certificate has not been issued, it shall suspend or withdraw the certificate issued, bearing in mind the principle of proportionality, unless the manufacturer ensures compliance with those requirements by implementing effective corrective measures. In cases of suspension or withdrawal of the certificate, or in cases where restrictions are placed, or where the intervention of the competent authority may be required, the notified body shall inform the Directorate-General of the facts. General of Pharmacy and Sanitary Products moving a copy of the corresponding decision. The Directorate-General for Pharmacy and Health Products shall inform the other Member States and the Commission. The Directorate-General for Pharmacy and Health Products shall keep the Autonomous Communities informed of suspended or withdrawn certificates. "

c) A new paragraph 6a is added:

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

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

The text of the first transient disposition is replaced by:

" 1. Until 14 June 1998, it will be permitted:

(a) The placing on the market of medical devices complying with the regulations in force in Spain on 31 December 1994.

(b) Free marketing of medical devices which were not subject to any national legislation on 31 December 1994.

2. Until 30 June 2001, the placing in service of the products referred to in the preceding paragraph shall be permitted. "

F) Annex II.

Paragraph 6.2 is deleted.

G) Annex III.

Paragraph 7.1 is deleted.

H) Annex V.

Paragraph 5.2 is deleted.

I) Annex VI.

Paragraph 5.2 is deleted.

J) Annex XI.

The following paragraph is added after the second sentence of paragraph 3:

" This presupposes the availability of sufficient scientific staff within the organisation, which has the appropriate expertise and knowledge to assess, from a medical point of view, functionality and the performance of the products which have been notified to it, in relation to the requirements of this Royal Decree, and in particular the requirements of Annex I. '

2. In addition, the same Royal Decree 414/1996 of 1 March, for which medical devices are regulated, is amended as follows:

A) Article 5 is amended as follows:

a) In paragraph 1, the following paragraphs are included between the first and the second.

" To obtain these authorizations, the companies that develop such activities will request them from the Directorate General of Pharmacy and Health Products, which will study the documentation presented and will notify their a decision within three months from the date on which the application and the accompanying documentation have entered into any of the records of the Ministry of Health and Consumer Affairs.

The Directorate-General for Pharmacy and Health Products will ask the health areas of the Government Delegations to report on the conditions under which companies develop the related activities in this section, (a) to provide for inspections of the facilities of such undertakings which are necessary. Since the requested report is a determining factor in the content of the decision to be taken, it shall suspend the period of the maximum period of three months of the procedure, for as long as the request for the report is concerned, the undertaking concerned, and its receipt, which shall also be communicated to it, and without the period of suspension being allowed to exceed in any case of three months, all in accordance with the provisions of Article 42.5.c) of Law No 30/1992, of 26 May November, the Legal Regime of Public Administrations and the Common Administrative Procedure, in the the wording given by Law 4/1999, of 13 January, of amendment of that Law.

The report referred to in the preceding paragraph shall not be requested when companies develop manufacturing, grouping, sterilisation and storage activities in installations established outside the Spanish territory. "

(b) The following sentence is added to paragraph 5:

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

B) Article 7 (4) is replaced by the following:

" It shall be prohibited to place marks or inscriptions which may induce third parties to misinterpretation in relation to the meaning or graphics of the CE marking or which detract from the significance of the CE marking. The product, package or package leaflet accompanying the product may be placed on the product, provided that the visibility and legibility of the CE marking is not thereby reduced. '

C) The following sentence is added to Article 8 (1.4

:

" The Directorate-General for Pharmacy and Health Products shall, where appropriate, assess the documentation referred to in that Annex for the purposes of establishing the conformity of the products after they have been placed on the market and/or posts in service. "

D) The text of the first paragraph of Article 14 is replaced by:

" Every manufacturer established in Spain which places products of classes I and IIa on the market, as well as tailor-made products, shall be included in the register of marketing officers operating in the Directorate-General for Pharmacy and Sanitary Products, where it will consist of its social name and the relation of the products that it commercializes or puts into service, specifying type of product, manufacturer, class and commercial name. This obligation shall be extended to the authorised representative in the European Union, responsible for the placing on the market or importer of products manufactured outside the European Union when they are established in Spain. "

E) Article 16 is amended as follows:

(a) The text in paragraph 2 is replaced by:

" The distribution and sale to the public shall be subject to the supervision and inspection of the health authorities of the corresponding Autonomous Community, who may establish the procedure required for the authorization of such activities. "

(b) The text of the last paragraph of paragraph 3 is replaced by:

"With the exception of such a declaration of activity, the pharmacy offices shall be exempt from the activities referred to in Article 18 (1)."

F) Article 19 is amended as follows:

(a) A new paragraph is added to paragraph 1:

" Where clinical investigations are carried out with products bearing the CE marking, paragraphs 3, 4, 5, 6, 7 and 8 of this Article shall not apply to them, unless such investigations have the effect of the purpose of the use of the products in an indication other than that referred to in the relevant conformity assessment procedure. The corresponding provisions of Annex X shall continue to apply, with the exception of paragraph 2.4. '

(b) Paragraph 6 is read as follows:

" 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 of classes IIa or IIb, investigations may be initiated if 15 days from the acknowledgement of receipt by the Directorate-General for Pharmacy and Health Products, the Directorate-General for Pharmacy and Health Products has not acted, and provided that the favourable report of the Ethics Committee for Clinical Research is provided. "

G) The second sentence of Article 23 (7) is replaced by the following:

" Against such a decision, it may be brought directly to the administrative or administrative proceedings or, as provided for in Articles 116 and 117 of Law 30/1992, of 26 May 1992, to be brought directly to the Court of Justice. November, the Legal Regime of Public Administrations and the Common Administrative Procedure. "

H) The text of Article 24 (2) is replaced by:

" The Directorate-General of Pharmacy and Health Products, by itself or through the inspection services of the General Administration of the State authorized for these purposes, may exercise inspection and control activities in respect of the products referred to in Chapter VI and the establishments in which they are manufactured, imported or exported, provided that they are situated in national territory. It may also carry out, without prejudice to the powers of other Sanitary Administrations, the inspection and monitoring of clinical investigations of products which do not bear the CE marking. '

I) Article 25 is amended as follows:

(a) The text in paragraph 3 is replaced by:

" After having carried out its assessment, if possible jointly with the manufacturer, the Directorate-General for Pharmacy and Health Products shall inform the European Commission and the other Member States of the facts in respect of which have been taken or are considered to be able to take appropriate action. "

(b) The text of the first indent of paragraph 4 is replaced by:

"Heart implants and vascular implants of the central circulatory system."

(c) The third and fifth indents of paragraph 4 are deleted.

J) Article 26 is amended as follows:

(a) The text in the first paragraph of paragraph 1 is replaced by:

" If there are prima facie evidence on the conformity of a product, the health authorities may require the manufacturer, importer or person responsible for placing on the market in the European Union to submit the the official Spanish language of the State of any information deemed necessary to judge on that conformity.

The refusal to provide the indicated documentation may be considered as a presumption of non-compliance. "

(b) The text of the first subparagraph of paragraph 3 is replaced by:

" As a guarantee of the health and safety of persons, the competent health authorities, when they consider that a product correctly put into service, installed, maintained and used in accordance with its purpose It may compromise the health and/or safety of patients, users or third persons shall take the appropriate measures provided for in Chapter V of Title I of Law 14/1986 of 25 April, General Health, and in the Chapter I of Title IX and Article 110 of Law 25/1990 of 20 December of the Medication. "

c) The text in paragraph 6 is replaced by:

" Where a non-compliant product has the CE marking, the competent health authorities shall take appropriate measures against those who have affixed the marking and shall inform the Directorate-General of Pharmacy and Products thereof. Sanitary. That management centre shall act accordingly and shall communicate it to the European Commission and the competent authorities of the other Member States. '

d) The text in paragraph 10 is replaced by:

" When verification of the conformity of a product requires the performance of evaluations or tests on the product or its technical documentation, the costs resulting from the verification shall be satisfied by the manufacturer or its controller, who shall also provide the necessary samples to carry out such verification. '

e) The text in paragraph 11 is replaced by:

" Where the placing on the market and/or putting into service of a product is rejected or restricted by the application of this Royal Decree, as well as when the withdrawal of a product from the market takes place, the person concerned may express their disagreement with the hierarchical superior body of the decision, by means of the appropriate appeal within one month, in accordance with the provisions of Articles 114 and 115 of the Law on the Legal Regime of the Public administrations and the Common Administrative Procedure. '

K) In Article 27, the second paragraph is deleted.

L) The text of Article 28 is replaced by:

" 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 the confidentiality of any information obtained in the exercise of its function. This shall not affect the obligations of the competent authorities and the notified bodies in respect of reciprocal information, the dissemination of warnings or the reporting obligations of the persons concerned, both before the authorities and before the courts. "

M) Article 29 is amended as follows:

(a) The second sentence of paragraph 4 is replaced by:

"Advertising messages that are inserted in any of the general media shall be the subject of prior authorisation by the health authorities of the Autonomous Communities."

(b) The text in paragraph 6 is replaced by:

" In the advertising of products addressed to the public and carried out by individuals, any mention referring to a health authority or to recommendations that have been formulated by scientists, professionals of the health or other persons who may, due to their notoriety, incite their use. "

N) In Article 32 the last sentence is replaced by:

"Such demonstrations may never involve the use of such products in patients."

N) Article 33 is amended as follows:

(a) In paragraph 2, Serious infractions, two new paragraphs are added:

" 16. The putting into service in Spain of medical devices which do not include the data contained in paragraphs 2.7, 5.4 and 7 of Annex I at least in the official Spanish language of the State.

17. The misuse of the CE marking on non-conforming products or on the products referred to in Article 7 (5). "

b) The text in paragraph 2.9 is replaced by:

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

c) In paragraph 3, very serious infractions, two new paragraphs are added:

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

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

O) The text of the fourth additional disposition, application of rates, is replaced by:

"The procedures referred to in Articles 8.1, 12 and 19.3 shall apply to them the corresponding fees set out in Article 117 of Title X of Law 25/1990 of 20 December of the Medication."

P) In the fifth additional provision, Extension, the second indent of the first paragraph is replaced by:

"Appliances and instruments used in permanent, semi-permanent or skin tattoo makeup using invasive techniques."

Q) Second transitional provision, adaptation of the obligations on marketing communication.

The second paragraph text of the second transient disposition is replaced by:

"For the communications of the products referred to in paragraph 1.a) of the first transitional provision, the fee set out in the fourth additional provision shall not apply to them."

R) First Repeal Disposition.

The text of the last paragraph of paragraph 2 of the first paragraph of the derogation is amended as follows:

"All in the time they object to this Royal Decree and in the field of the products included in their field of application."

Additional disposition octave. Amendments to Royal Decree 634/1993 of 3 May.

Royal Decree 634/1993 of 3 May on active implantable medical devices is amended as follows:

1. In Article 7, the text of paragraph 4 is replaced by:

" 4. Active implantable medical devices for clinical investigations:

(a) The conduct of clinical investigations with active implantable 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 establishing the requirements for the conduct of clinical trials with medicinal products, as set out in the first provision of the said Royal Decree.

(b) Where clinical investigations are carried out with products bearing the CE marking, paragraphs 5, 6, 7, 8 and 9 of this Article shall not apply to them, unless such investigations have the effect of the purpose of the use of the products in an indication other than that referred to in the relevant conformity assessment procedure. The corresponding provisions of Annex X shall remain applicable.

c) Products intended for clinical research may be made available to medical practitioners only if this research has the favourable opinion of the Ethical Committee referred to in Article 64 of Law 25/1990, December 20, of the Medication, and its development provisions. This forecast will be extended to changes in ongoing clinical investigations that may lead to increased risk to the subjects involved in the trial. "

2. Article 19 is amended as follows:

(a) The text in paragraph 3 is replaced by:

" After having carried out its assessment, if possible jointly with the manufacturer, the Directorate-General for Pharmacy and Health Products shall inform the European Commission and the other Member States of the facts in respect of which have been taken or are considered to be able to take appropriate action. "

b) A new section is added:

" 4. The active implants that are distributed in Spain must be accompanied by an implantation card. This card will not be required for the "software" required for the proper functioning of the products.

The implantation card, in triplicate, shall include at least the name and model of the product, the batch number or serial number, the name and address of the manufacturer, the name of the health centre where the implementation and date of 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. '

3. The text of Article 21 is replaced by:

" The health authorities, without prejudice to the existing provisions on professional secrecy, shall ensure that all the 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 competent authorities and the notified bodies with regard to reciprocal information and the dissemination of warnings, or to the reporting obligations of the persons concerned, either before the health authority as before the courts. "

4. The following items are included:

" Article 22a. Incentives.

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 health use, prescription or dispensing of products as well as their relatives or persons with whom they live.

Persons listed in the previous section may not request or accept any of the prohibited incentives.

Article 22b. 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 clinical practitioners or the entities in which they are associated.

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

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 of the products. "

5. In Article 23 (2), serious infringements, a new paragraph is added:

"11. The putting into service in Spain of active implantable medical devices that do not include the data contained in paragraphs 3 and 4 of Annex I at least in the official Spanish language of the State."

6. In Annex VII, paragraph 2, a new paragraph 4 is

:

" 4. Samples.

(a) Samples of implantable medical devices active for use 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 shall 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 shall monitor the supply of the samples to be used in the clinical trial. "

7. The text of the additional provision fourth. Rate Application, is replaced by:

"The procedures referred to in Articles 6, 7.5 and 9 of this Royal Decree shall apply to them the fees set out in Article 117 of Title X of Law 25/1990 of 20 December of the Medication."

Additional provision ninth. Publication of the 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 Directive 98 /79/EC, published in the Official Journal of the European Communities (OJ).

Additional provision 10th. 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 "in vitro" diagnostic medical devices.

1. Until 7 December 2003, it will be permitted:

(a) The placing on the market of "in vitro" diagnostic medical devices complying with the regulations in force in Spain at 7 December 1998.

(b) The free marketing of "in vitro" diagnostic medical devices which were not subject to any national legislation on 7 December 1998.

2. Until 7 December 2005, the placing in service of the products referred to in the preceding paragraph shall be permitted.

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

The companies responsible for products that have health authorization to place on the market and are marketed in Spain at the entry into force of this Royal Decree, must comply with the article 10 at the time of commencement of CE marked marketing.

For the communications of the products referred to in paragraph 1 (a) of the first transitional provision, the fee set out in the fifth additional provision shall not apply to them.

Transitional provision third. Adaptation of manufacturing and import activities.

Until 7 December 2003, the manufacture and import of medical devices for "in vitro" diagnosis will be permitted under the conditions laid down by the regulations in force in Spain on 7 December 1998. Until the same date, the free manufacture and import of medical devices will be permitted until the same date, which, on 7 December 1998, would not be subject to conditions for such activities.

Transitional disposition fourth. Adaptation of the distribution activities.

It is fixed on 1 January 2002 as the deadline for distribution establishments to carry out the communication referred to in Article 14 (1).

Single repeal provision. Regulatory repeal.

1. Article 1 (b) of Royal Decree 908/1978 of 14 April 1978 on sanitary control and approval of medical, therapeutic and corrective equipment and instruments is hereby repealed.

2. The following provisions are hereby repealed with effect from 7 December 2003:

(a) Resolution of 20 March 1987, of the Subsecretariat, establishing the procedure and documentation necessary to obtain the authorization of reagents for the testing of the detection of markers human virus infection of the family "retroviridae", including tests for the detection of antibodies against viruses associated with Acquired Immune Deficiency Syndrome (AIDS) and the detection of antigens corresponding to them.

b) Resolution of 11 September 1989, of the Secretariat, which regulates the carrying out of processes for the controlled investigation of reagents for the detection of markers of human virus infection of the family "retroviridae", including those associated with Acquired Immune Deficiency Syndrome (AIDS).

c) Order of the Minister of Health and Consumer Affairs of 13 June 1983 regulating the sterile medical-surgical material and instruments to be used only once.

All as long as they object to this Royal Decree and in the area of the products included in its field of application.

Final disposition first. Faculty of development.

The Minister of Health and Consumer Affairs is empowered to make any provisions necessary for the implementation and development of this Royal Decree.

Final disposition second. Entry into force.

This Royal Decree shall enter into force on the day following that of its publication in the "Official Gazette of the State".

Given in Madrid on September 29, 2000.

JOHN CARLOS R.

The Minister of Health and Consumer Affairs,

CELIA VILLALOBOS TALERO

ANNEX I

Essential design and manufacturing requirements

1. Physical and chemical properties.

1.1 Products must be designed and manufactured in such a way as to present the characteristics and benefits referred to in Article 5 "General requirements" of this Royal Decree. Particular account shall be taken of the possibility of deterioration of the analytical performance due to the incompatibility between the materials used and the samples (such as biological tissues, cells, body fluids and micro-organisms). are to be used with that product, having regard to its intended purpose.

1.2 Products must be designed, manufactured and packaged in such a way as to reduce as far as possible the risks arising from possible leakage, contaminants and residues for persons responsible for transport, storage and use. of the products, having regard to their intended purpose.

2 Infection and microbial contamination.

2.1 Products and manufacturing processes must be designed in such a way as to eliminate or minimise the risk of infection of the user or other persons. The design shall allow for easy handling and, where necessary, to minimise contamination and leakage from the product during use, as well as, in the case of sample containers, the risk of contamination of the product. shows. Manufacturing processes shall be appropriate for these purposes.

2.2 When a product contains biological substances, the risks of infection shall be minimised by selecting appropriate donors and substances and applying appropriate inactivation, conservation, testing and control procedures. and validated.

2.3 Products labelled "STERILE" or those indicated to have a special microbiological status must be designed, manufactured and conditioned in appropriate packaging, in accordance with appropriate procedures. ensure that the products are kept in the appropriate microbiological state indicated on the label when placed on the market and under the storage and transport conditions laid down by the manufacturer, until the opening or deterioration of the protective package.

2.4 Products labelled "STERILE" or those indicated to have a special microbiological status must have been developed by an appropriate validated method.

2.5 The packaging systems for products other than those referred to in paragraph 2.3 shall keep the product, without deterioration, at the level of cleanliness indicated by the manufacturer and, if it is to be sterilised prior to their use, minimize the risk of microbial contamination.

Measures should be taken to reduce as much as possible microbial contamination in the selection and handling of raw materials, manufacturing, storage and distribution in the event that such contamination could alter the operation of the product.

2.6 Products that need to be sterilized must be manufactured in adequately controlled conditions (e.g. environment).

2.7 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 be minimise the risk of microbial contamination; the packaging system shall be appropriate, depending on the sterilisation method indicated by the manufacturer.

3. Properties related to manufacturing and the environment.

3.1 If the product is intended to be used in association with other products or equipment, the whole package, including the system of connection, must be safe and not alter the indicated performance of the products. Any restrictions on their use shall be indicated on the label or on the instructions for use.

3.2 Products must be designed and manufactured in such a way as to minimise risks related to their use in conjunction with materials, substances and gases with which they may come into contact during their use. normal.

3.3 Products must be designed and manufactured in such a way as to be removed or reduced to a minimum:

-The risks of injuries arising from their physical characteristics (in particular the pressure volume, dimensional and, where appropriate, ergonomic aspects),

-Risks related to reasonably foreseeable external influences such as magnetic fields, external electrical influences, electrostatic discharges, pressure, humidity, temperature or pressure or pressure variations acceleration, or accidental entry of substances into the product.

Products must be designed and manufactured in such a way as to present an adequate level of intrinsic immunity against electromagnetic disturbances which will enable them to function according to the purpose for which they have been intended.

3.4 Products must be designed and constructed in such a way as to minimise the risks of fire or explosion during normal use and under conditions of first defect. Special attention shall be given to products whose intended purpose includes exposure to flammable substances or which may lead to combustion, or joint use with such substances.

3.5 Products should be designed and manufactured in such a way as to facilitate the management of safe disposal of waste.

3.6 The measurement, control or display scale (including colour change and other visual indicators) shall be designed and constructed in accordance with ergonomic principles, taking into account the intended purpose of the product.

4 Products that are instruments or apparatus with measurement function.

4.1 Products that are instruments or apparatus with a primary analytical measurement function shall be designed and constructed in such a way as to provide adequate stability and accuracy of measurement within a range of margins. accuracy, taking into account the intended purpose of the product and the available and appropriate reference measurement methods and materials. The manufacturer shall specify the accuracy margins.

4.2 Where the values are expressed in numerical form, they shall be given in units of legal measure 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 legislation of the Member States on units of measurement.

5 Radiation Protection.

5.1 Products must be designed, manufactured and packaged in such a way that the exposure of users and other persons to radiation emissions is minimised.

5.2 When products are intended to emit potentially hazardous, visible or invisible radiation, as far as possible,

-Must be designed and constructed in such a way that its characteristics and the quantity of radiation emitted are controllable or adjustable,

-To be equipped with visual indicators or sound alarms of such emissions.

5.3 Instructions for the use of radiation-emitting products will give detailed information on the nature of the radiation emitted, the means of protection of the user and ways to prevent incorrect and eliminate the risks arising from the installation.

6 Requirements for sanitary products connected to or equipped with a power source.

6.1 Products carrying programmable electronic systems, including computer programs, should be designed in such a way as to ensure the repeatability, reliability and operation of these systems according to the intended purpose.

6.2 Products must be designed and constructed in such a way as to minimise the risk of creating electromagnetic disturbances which may damage the operation of other products or equipment in the usual environment.

6.3 Products shall be designed and constructed in such a way as to avoid as far as possible the risk of accidental electrical discharges during normal use and under conditions of first defect, provided that the products are installed and maintained correctly.

6.4 Protection from mechanical and thermal hazards.

6.4.1 Products must be designed and manufactured in such a way that the user is protected against mechanical hazards. The products shall have sufficient stability under the intended operating conditions. They shall be capable of resisting the efforts inherent in the intended field of operation, and shall maintain such resistance during the period of the intended duration of the products, provided that the maintenance and maintenance requirements are respected. inspection indicated by the manufacturer.

Where there are risks due to the presence of movable elements, risks due to breakage or detachment or leakage of substances, appropriate protective measures shall be incorporated.

Any safeguard or other means included in the product to ensure protection, in particular against mobile elements, must be safe and not hinder access to the normal use of the product, or restrict the use of normal maintenance of the product indicated by the manufacturer.

6.4.2 Products must be designed and manufactured in such a way as to reduce the risks arising from the vibrations generated by the products at the lowest possible level, taking into account the technical progress and the means of have the right to limit vibrations, in particular at their origin, unless the vibrations are part of the specified performance.

6.4.3 Products must be designed and constructed in such a way as to reduce the risks arising from the noise emitted at the lowest possible level, taking into account technical progress and the means available to reduce noise, in particular at its origin, unless the noise emitted is part of the specified performance.

6.4.4 The terminals and devices for connection to the source of electricity, gas or hydraulic or pneumatic energy that the user has to manipulate must be designed and constructed in such a way as to minimise all risks possible.

6.4.5 The accessible parts of the products (excluding parts or areas intended to provide heat or to reach certain temperatures) and the surrounding parts must not be capable of potentially reaching temperatures dangerous under normal use circumstances.

7. Requirements for self-diagnostic products.

Self-diagnosis products must be designed and manufactured in such a way that their performance is in line with the intended purpose, given the capacity and means available to the user and the influence they may have. reasonably foreseeable variations of the user's technique and environment. The information and instructions given by the manufacturer shall be easily understood and applied by the user.

7.1 Self-diagnostic products must be designed and manufactured in such a way that:

-It is ensured that the product is easily used, at all stages of its handling, by the non-professional user to whom it is intended, and

-Reduce all possible risk of error by the user in handling the product and interpreting the results.

7.2 Self-diagnosis products must include, where reasonably possible, a user control, that is, a procedure that allows the user to verify that, at the time he/she will use it, the product will work as it is due.

8. Information provided by the manufacturer.

8.1 Each product must be accompanied by the information necessary to use it correctly and safely, depending on the preparation and knowledge of potential users, and to identify the manufacturer.

This information will consist of the label data and the instructions for use.

To the extent that it is feasible and appropriate, the information necessary to use the product correctly and safely must be on the product itself and/or, where applicable, on the sales package. If it is not possible to fully label each unit, the information shall appear on the packaging or in the instructions for use provided with one or more products.

The instructions for use must accompany the packaging of one or more products, or be included in the package.

In duly justified and exceptional cases, these instructions for use will not be necessary if the product can be used correctly and safely without them.

8.2 Where appropriate, the information to be provided shall be expressed in the form of symbols. The identification symbols and colours used shall comply with the harmonised standards. In sectors where there are no rules, the symbols and colours used in the documentation provided with the product shall be described.

8.3 In the case of products containing a substance or a preparation which can be considered dangerous, taking into account the nature and quantity of its constituents and the way in which they are presented, the requirements shall apply. (a) relevant to the danger and labelling symbols of the Royal Decrees 2216/1985 of 28 October and 1078/1993 of 2 July 1993. Where sufficient space is not available to record all information on the product itself or on its label, the relevant danger symbols shall be placed on the label and the rest of the label shall be collected on the instructions for use. information required by those provisions.

The provisions of the above regulations relating to the safety data sheet shall apply, unless the instructions for use have already adequately provided all relevant information.

8.4 On the label shall contain the following data, which may be in the form of symbols where appropriate:

a) The name or social reason and address of the manufacturer. In the case of products imported into the Community for the purpose of distributing them on the label, the outer packaging or the instructions for use shall also contain the name and address of the authorised representative of the manufacturer.

b) The data strictly necessary for the user to identify the product and contents of the packaging unequivocally.

(c) Where applicable, the word "ESTERIL" or an indication of any special microbiological or cleaning status.

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

e) If necessary, an indication of the date before which the product or part of it must be used for full security, without degradation of the performance, expressed in year, month and, if applicable, day.

f) In the case of products for performance evaluation, the words "only for performance evaluation".

g) Where appropriate, an indication of the "in vitro" use of the product.

h) Specific storage or maintenance conditions.

i) Where appropriate, special handling instructions.

j) Relevant warnings or precautions to be taken.

k) If the product is intended for self-diagnosis, this is clearly indicated.

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

8.6 Whenever it is reasonable and feasible, the products and the separate components shall be identified, in batches where appropriate, in order to allow for all appropriate measures to detect any potential risk posed by the products and the detachable components.

8.7 The instructions for use must contain, as appropriate, the following data:

(a) Those referred to in paragraph 8.4, with the exception of paragraphs (d) and (e).

(b) The composition of the reactive product according to the nature and quantity or concentration of the active substance (s) of the reagent (s) or reagent (s) or case of instruments and materials, as well as a declaration, when The product contains other components that could influence the measurements.

(c) The storage conditions and the period of validity after the first opening of the primary packaging, together with storage conditions and the stability of the work reagents.

(d) The benefits referred to in Article 5 (3).

e) The indication of any special equipment that is needed, including the information necessary for the identification of these special equipment with a view to correct use.

(f) The type of sample to be used, the special collection conditions, the prior treatment and, if necessary, the storage conditions and instructions for the preparation of the patient.

g) The detailed description of the procedure to be followed when using the product.

h) The measurement procedure to be followed with the product, including, where appropriate, the following data:

-The beginning of the method.

-The specific operating characteristics of the analysis (e.g. sensitivity, specificity, accuracy, repeatability, reproducibility, detection limits and measurement margin, including the information required for the analysis). control of the relevant known interference), the limitations of the method and the information about the use, by the user, of the reference measurement procedures and reference materials available.

-Data from any other necessary procedure or manipulation before the product can be used (e.g. reconstitution, incubation, dilution, instrument controls, etc.).

-The indication of the eventual need for special training.

i) The mathematical approach on which the calculation of the analytical result is based.

j) The measures to be taken in case of changes in the analytical operation of the product.

k) The appropriate information for users about:

-Internal quality control, including validation-specific methods.

-The mapping of the product calibration.

l) The reference intervals for the quantities to be determined, including a description of the reference population to be considered.

m) If the product is to be used in association with other medical devices or equipment, or installed or connected with them to operate as required by its intended purpose, sufficient data of its characteristics to be known which are the appropriate products or equipment to be used to obtain an appropriate and secure association.

n) All information necessary to verify if the product is properly installed and can operate correctly and safely, in addition to data on the nature and frequency of maintenance and calibration required for permanently ensure the correct and safe functioning of the product, and information on safe disposal of waste.

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

p) The necessary instructions in case of deterioration of the protective package and data on the appropriate methods of resterilization or decontamination.

q) If the product is reusable, information about the appropriate processes that allow reuse, including cleaning, disinfection, packaging and resterilization or decontamination, as well as any restrictions of the number of reuses.

r) The precautions to be taken as regards exposure, under reasonably foreseeable environmental conditions, to magnetic fields, external electrical influences, electrostatic discharges, pressure or variations of pressure, acceleration, thermal ignition sources, etc.

s) The precautions to be taken against any specific and unusual risk arising from the use or disposal of the product, including special protective measures; where the product includes substances of human origin or animal, its potentially infectious nature shall be noted.

t) Specifications for self-diagnostic products:

-The results must be expressed and presented in such a way as to be easily understandable by a profane; the user must be provided with information on the attitude to be taken (in the event of a positive, negative or indeterminate) and on the possibility of false positive or false negative results.

-Specific data may be omitted provided the other information provided by the manufacturer is sufficient for the user to be able to use the product and interpret the results obtained with it.

-The information provided will include a clear indication that the user should not make any medical importance decisions without consulting with their physician.

-The information should also specify that, when a self-diagnostic product is used to control an existing disease, the patient should only adapt the treatment when he has received the necessary training for this.

u) The most recent publication or review date of the usage instructions.

ANNEX II

List of products referred to in paragraphs 1.1 and 1.2 of Article 7

List A.

-Reactive and reactive products, including associated calibration and control materials, for the determination of the following blood groups: ABO system, Rhesus (C, c, D, E, e) and antiKell.

-Reactive and reactive products, including associated calibration and control materials, for the detection, confirmation and quantification in human samples of markers of HIV infection (HIV 1 and 2), HTLV I and II and hepatitis B, C and D.

List B.

-Reactive and reactive products, including associated calibration and control materials, for the determination of the following blood groups: anti-Duffy and anti-Kidd.

-Reactive and reactive products, including associated calibration and control materials, for the determination of irregular antierythrocytic antibodies.

-Reactive and reactive products, including associated calibration and control materials, for detection and quantification in human samples of the following congenital infections: rubella and toxoplasmosis.

-Reactive and reactive products, including associated calibration and control materials, to diagnose the following hereditary disease: phenylketonuria.

-Reactive and reactive products, including associated calibration and control materials, for the determination of the following human infections: cytomegalovirus and Chlamydia.

-Reactive and reactive products, including associated calibration and control materials, for the determination of the following tissue groups: DR, A, B.

-Reactive and reactive products, including associated calibration and control materials, for the determination of the following tumor marker: PSA.

-Reactive and reactive products, including associated calibration and control materials, as well as software specifically intended for the assessment of the risk of trisomy in the 21st pair.

-The next product for self-diagnosis, including the associated calibration and control materials: equipment for the measurement of blood glucose.

ANNEX III

EC Declaration of Compliance

1. The EC declaration of conformity is the procedure whereby the manufacturer or his authorised representative fulfils the obligations imposed by paragraphs 2 to 5 and, in addition, in the case of products for self-diagnosis, by paragraph 6. ensures and declares that the products in question comply with the provisions of this Royal Decree which are applicable to them. The manufacturer shall affix the CE marking in accordance with Article 6.

2. The manufacturer shall prepare the technical documentation described in paragraph 3 and ensure that the manufacturing process complies with the quality assurance principles set out in paragraph 4.

3. The technical documentation shall enable the conformity of the product to be assessed with the requirements of the Royal Decree. It shall include, in particular:

-A general description of the product, including expected variants.

-The documentation for the quality system.

-Information about the design, including the identification of the characteristics of the base materials, the characteristics and limitations of the operation of the products, methods of manufacture and, in the case of instruments, design plans, component diagrams, subassemblies, circuits, etc.

-In the case of products containing tissues of human origin or substances derived therefrom, information on the origin and on the conditions of collection of such materials.

-The descriptions and explanations necessary for the understanding of the mentioned characteristics, drawings and diagrams, as well as the operation of the product.

-Risk analysis results, where applicable, and list of the standards referred to in Article 8, applied in whole or in part, and description of the solutions adopted to meet the essential requirements of the Royal Decree if the standards referred to in Article 8 have not been fully applied.

-In the case of sterile products or products with a microbiological or special cleaning status, description of the procedures used.

-Results of design calculations and inspections performed, etc.

-If the product must be combined with another or other products to work as intended, evidence is provided that it meets the essential requirements of being combined with any such product that has the characteristics specified by the manufacturer.

-Test reports.

-Appropriate performance assessment data, demonstrating the operation claimed by the manufacturer and supported by a reference measurement system (if available) together with the information on the methods of operation the reference materials, the reference material, the reference values, the accuracy and the units of measurement used; this data must have been obtained from studies in a clinical setting or other appropriate environment or derived from the relevant bibliographic references.

-Labels and instructions for use.

-Stability studies results.

4. The manufacturer shall take the necessary measures to ensure that the manufacturing process complies with the principles of quality assurance in an appropriate manner on the basis of the products manufactured.

The system will cover the following aspects:

-The organizational structure and responsibilities.

-Manufacturing processes and systematic quality control of production.

-The means of controlling the operation of the quality system.

5. The manufacturer shall establish and keep up to date a systematic process of analysis of the experience acquired with the products in the post-production phase, and of putting into practice the appropriate means to implement the measures. necessary corrective action, taking into account the nature and risks inherent in the product. It shall notify the competent authorities of the following facts as soon as they are aware of them:

(i) Any malfunction, failure or deterioration of the characteristics or performance of a product, as well as any deficiencies in the labelling or instructions for use which, directly or indirectly, could or could have resulted in the death of a patient or user or other persons or a serious deterioration of their health status.

(ii) Any technical or health reason linked to the characteristics or operation of a product for the reasons set out in paragraph (i) above which has resulted in the systematic withdrawal of products from the same product type by the manufacturer.

6. In the case of products for self-diagnosis, the manufacturer shall submit to a notified body a request for examination of the design.

6.1 The application must enable the design of the product to be understood and to assess its conformity with the design requirements of the Royal Decree. It will include the following aspects:

-Test reports to include, where appropriate, the results of studies conducted with profane.

-Data showing the adequacy of the product to be manipulated in view of its intended purpose of self-diagnosis.

-The information to be provided along with the product, both on the label and in the instructions for use.

6.2 The notified body shall examine the application and, if the design complies with the relevant provisions of this Royal Decree, it shall issue to the applicant an EC design examination certificate. The notified body may require the completion of the application with other tests or tests to enable the conformity assessment with the requirements of the Royal Decree relating to the design. 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 intended purpose of the product.

6.3 The applicant shall inform the notified body that it has issued the EC design examination certificate of any major modification which has been introduced in the approved design. Modifications to the approved design shall be accompanied by an additional approval of the notified body which has issued the EC design examination certificate, provided that the modifications are likely to affect conformity with the essential requirements of the Royal Decree or with the conditions laid down for the use of the product. This supplementary approval shall be in the form of an appendix to the EC design examination certificate.

ANNEX IV

CE declaration of compliance (total quality assurance system)

1. The manufacturer shall ensure that the approved quality system for the design, manufacture and final inspection of the products concerned is applied, as specified in paragraph 3, and shall be subject to the audit referred to in paragraph 1. paragraph 3.3 and the control specified in paragraph 5. In addition, the manufacturer shall follow the procedures set out in paragraphs 4 and 6

the products listed in Annex II.

2. The declaration of conformity is the procedure whereby the manufacturer who satisfies the requirements imposed by paragraph 1 ensures and declares that the products in question comply with the provisions of this Royal Decree which are applicable.

The manufacturer shall affix the CE marking in accordance with Article 6 and make a written declaration of conformity concerning the products concerned.

3. Quality System:

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

This request must contain:

-The name and address of the manufacturer and any other manufacturing premises within the quality system.

-Appropriate information about the product or category of products that are the object of the procedure.

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

-The documentation for the quality system.

-The manufacturer's commitment to meet the obligations imposed by the approved quality system.

-The manufacturer's commitment to ensuring that the approved quality system maintains its adequacy and effectiveness.

-The manufacturer's commitment to establish and maintain an updated systematic review of the experience acquired with the products in the post-production phase, and the implementation of the appropriate means to implement the necessary corrective measures and to make the notification referred to in paragraph 5 of Annex III.

3.2 The application of the quality system must ensure the conformity of the products with the provisions of this Royal Decree that apply to them in all phases, from the design to the final inspection. 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 plans and procedures, such as quality programmes, quality, quality manuals and quality records.

In particular, this documentation should contain an appropriate description of:

a) The quality objectives of the manufacturer.

b) The organization of the company and in particular:

-The organisational structures, responsibilities of managers and their organisational authority in terms of the quality of the design and manufacture of the products.

-The methods to control the effective functioning of the quality system and, in particular, its ability to achieve the desired quality in design and product, including the control of non-compliant products;

(c) The procedures for the control and verification of the design of the products, in particular:

-A general description of the product, including expected variants.

-All the documentation referred to in the third to thirteenth indents of paragraph 3 of Annex III.

-In the case of products for self-diagnosis, the information referred to in paragraph 6.1 of Annex III.

-The techniques used to control and verify the design and processes, and the systematic measures to be applied in the design phase of the products.

(d) Quality assurance and inspection techniques at the manufacturing stage and in particular:

-The processes and procedures to be used, especially as regards sterilization.

-The procedures regarding purchases.

-The product identification procedures developed and updated from drawings, specifications or other relevant documents at all stages of manufacture.

e) appropriate examinations and tests to be carried out before, during and after manufacture, the frequency with which they are to be carried out and the test equipment used; the correlation of calibration shall be ensured.

The manufacturer shall perform the relevant examinations and tests in accordance with the most advanced technical level. The examinations and tests shall relate to the manufacturing process, including the characterisation of the raw material, as well as to each product or batch of particular products manufactured.

With regard to the products listed in Annex II, List A, the manufacturer shall be aware of the latest knowledge in particular as regards the complexity and biological variability of the samples. which are to be studied with the in vitro diagnostic product in question.

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

The assessment team should have experience in evaluating the technology in question. The assessment procedure shall include an inspection of the manufacturer's premises and, in duly justified cases, of the facilities of the manufacturer's suppliers or subcontractors, in order to inspect the processes of manufacturing.

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

3.4 The manufacturer shall inform the notified body that it has approved the quality system of any major modification of the quality system or the range of products included.

The notified body shall evaluate the proposed amendments and check whether the quality system thus amended continues to comply with the requirements referred to in point 3.2. It shall inform the manufacturer of its decision, including the findings of the inspection and a reasoned assessment.

4. Product design review:

4.1 For the products listed in Annex II, list A, the manufacturer shall, in addition to the obligations relating to it in accordance with paragraph 3, submit to the notified body a request for examination of the design relating to the product to be manufactured and which forms part of the category referred to in paragraph 3.1

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

4.3 The notified body shall examine the application and, if the product complies with the requirements of this Royal Decree which are applicable, it shall issue an EC design examination certificate to the applicant. The notified body may require the application to be completed with additional testing or testing, so that compliance with the requirements of this Royal Decree 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.

4.4 The modifications to the approved design must be approved in addition to the notified body which has issued the EC design examination certificate, where such modifications may affect the design of the design. compliance with the essential requirements of this Royal Decree 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.

4.5 The manufacturer shall inform the notified body without delay when he has been aware of variations of the pathogenic agent and of the markers of the infections which are the subject of the test, and in particular those due to his Complexity or biological variability. In this respect, the manufacturer shall communicate to the notified body whether there is a likelihood of such variation having an impact on the operation of the 'in vitro' diagnostic medical device.

5. Control:

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

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

-The documentation for the quality system.

-The data stipulated in the part of the quality system relative to the design, such as analysis results, calculations, tests, etc.

-The data stipulated in the part of the manufacturing quality system, such as inspection reports and test data, calibration data, personnel qualification reports involved, etc.

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

5.4 In addition, the notified body may visit the manufacturer without notice. On the occasion of such visits, the notified body may, if necessary, carry out or request tests to verify the proper functioning of the quality system. It shall provide the manufacturer with an inspection report and, if any test has been carried out, a report of this.

6. Verification of the processed products listed in List A of Annex II:

6.1 In the case of products listed in Annex II, list A, the manufacturer shall communicate to the notified body, without delay and after completion of the examinations or tests, the relevant protocols on the examinations. of products or lots of manufactured products. In addition, the manufacturer shall make available to the notified body samples of products or batches of products manufactured in accordance with previously agreed terms and conditions.

6.2 The manufacturer may place the products on the market, except where the notified body informs it within the agreed time limit, which in any event shall not exceed 30 days from the receipt of the samples, a different decision, which may include, in particular, conditions for the validity of the certificates issued.

ANNEX V

EC type examination

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

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

The request must include:

-The name and address of the manufacturer, and the name and address of the authorized representative if the request is submitted by the authorized representative.

-The documentation described in paragraph 3 necessary to assess the conformity of the representative sample of the production concerned, hereinafter referred to as 'type', with the requirements of this Royal Decree. The applicant shall make a type available to the notified body. If necessary, the notified body may request further samples.

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

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

-A general description of the type, including expected variants.

-All the documentation referred to in the third to thirteenth indents of paragraph 3 of Annex III.

-In the case of products for self-diagnosis, the information referred to in paragraph 6.1 of Annex III.

4. The notified body:

4.1 Examine and evaluate the documentation and verify that the type has been manufactured in accordance with that documentation; it shall also indicate the elements that have been designed in accordance with the applicable provisions of the rules referred to in Article 5, as well as elements whose design is not based on the relevant provisions of those standards.

4.2 Realize or make appropriate checks and tests necessary to check whether the solutions adopted by the manufacturer meet the essential requirements of this Royal Decree, in case they are not applied the rules referred to in Article 5; where the product is to be combined with another or other products to operate as intended, evidence of compliance with the essential requirements shall be provided when combined with any a product of that type having the characteristics specified by the manufacturer.

4.3 It shall either bring the appropriate checks and the necessary tests to check whether, in case the manufacturer has decided to apply the relevant standards, they have actually been applied.

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

5. If the type is in accordance 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 examination, the conditions of validity and the data necessary for the identification of the approved type. The relevant parts of the documentation shall be attached to the certificate and a copy shall be kept by the notified body.

6. The manufacturer shall inform the notified body without delay when it has been aware of variations of the pathogenic agent and of the markers of the infections which are the subject of the test, in particular due to its complexity or variability. biological. In this respect, the manufacturer shall communicate to the notified body whether there is a likelihood of such variation having an impact on the operation of the 'in vitro' diagnostic medical device.

6.1 The modifications to the approved product must be approved in addition to the notified body which has issued the EC type-examination certificate, provided that the modifications are likely to affect conformity with the essential requirements of the Royal Decree or with the conditions stipulated for the use of the product. The applicant shall inform the notified body which has granted the EC-type examination certificate of any major modification to the approved product. This new approval shall take the form of an appendix to the EC initial type examination certificate.

7. Administrative provisions: The other notified bodies may obtain a copy of the EC type-examination certificates and their supplements. The Annexes to the certificates shall be made available to the other notified bodies, on a reasoned request and after the manufacturer has been informed.

ANNEX VI

CE Verification

1. EC verification is the procedure whereby the manufacturer or his authorised representative ensures and declares that the products subject to the procedure laid down 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 them.

2.1 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 requirements of the Royal Decree are applicable to them. Prior to the start of manufacture, the manufacturer shall prepare a documentation defining the manufacturing process, in particular as regards the sterilisation and suitability of the starting materials, where necessary, and the necessary testing procedures in accordance with the progress in this field. All previously established systematic provisions shall apply 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 requirements of the present Royal Decree that they are applicable to them.

2.2 To the extent that for certain aspects the final control in accordance with paragraph 6.3 does not proceed, the manufacturer, with the approval of the notified body, shall set appropriate test, surveillance and control methods during the process. In such a case, the provisions of paragraph 5 of Annex IV shall apply in accordance with the above mentioned procedures.

3. The manufacturer shall undertake to establish and maintain updated a systematic procedure for reviewing the experience acquired with the products in the post-production phase, and for the implementation of appropriate means of implementation. the necessary corrective measures and the notification referred to in paragraph 5 of Annex III.

4. The notified body shall carry out the appropriate checks and tests taking into account the provisions of paragraph 2.2 in order to verify the conformity of the product with the requirements of the Royal Decree, either by checking and testing each product. as specified in paragraph 5 or by examination and testing of the products in statistical form as specified in paragraph 6, at the choice of the manufacturer. When carrying out the statistical verification in accordance with paragraph 6, the notified body shall decide whether to apply statistical procedures for batch inspection per batch or whether the inspection of an isolated batch is to be carried out. Before taking this decision, the manufacturer shall be consulted.

If the conduct of examinations and tests in statistical form is not appropriate, checks and tests shall be carried out at random, provided that this procedure, together with the measures taken in accordance with paragraph 2.2, ensure an equivalent level of compliance.

5. Verification by examination and testing of each product:

5.1 Each product shall be individually examined and the appropriate tests defined in the relevant standard (s) referred to in Article 5, or equivalent tests, shall be carried out in order to verify the conformity of the products. products with the EC type described in the EC type-examination certificate and with the requirements of the Royal Decree applicable to them.

5.2 The notified body shall affix or affix its identification number to each approved product and issue a written certificate of conformity concerning the tests carried out.

6. Statistical verification:

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

6.2 One or more random samples shall be taken from each batch as necessary. The products consisting of the sample shall be individually examined and the appropriate tests defined in the relevant standard or standards referred to in Article 5, or equivalent tests, shall be carried out in order to verify, where appropriate, the conformity of the products with the type described in the EC type-examination certificate and with the requirements of the Royal Decree applicable to them, in order to determine the acceptance or rejection of the lot.

6.3 Statistical control of products will be based on attributes or variables, which involves sampling systems with operational characteristics that ensure a high level of safety and performance for the products. more modern knowledge. The sampling method shall be determined in accordance with the harmonised standards referred to in Article 5, taking into account the specific nature of the product categories concerned.

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

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

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

ANNEX VII

CE declaration of conformity (production quality assurance system)

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

2. The declaration of conformity is the part of the procedure whereby the manufacturer who fulfils the obligations imposed by paragraph 1 ensures and declares that the products concerned are in conformity with the type described in the examination certificate. EC type and which comply with the provisions of this Royal Decree which are applicable to them.

The manufacturer shall affix the CE marking in accordance with Article 6 and make a written declaration of conformity concerning the products in question.

3. Quality System:

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

This request must contain:

-All documentation and commitments referred to in Section 3.1 of Annex IV, and

-The technical documentation relating to the approved types and a copy of the EC type examination certificates.

3.2 The application of the quality system shall ensure the conformity of the products to 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 plans and procedures. This documentation of the quality system shall allow for a uniform interpretation of quality plans and procedures, such as quality programmes, projects, 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:

-The organizational structures, responsibilities of the managers and their organizational authority as regards the quality of the manufacture of the products.

-The methods to control the effective functioning of the quality system and, in particular, its ability to achieve the desired quality in the product, including the control of non-compliant products.

(c) Quality assurance and inspection techniques at the manufacturing stage and in particular:

-The processes and procedures that will be used in relation, above all, to sterilization.

-Shopping procedures.

-The product identification procedures developed and updated from drawings, specifications or other relevant documents at all stages of manufacture.

(d) The appropriate examinations and tests to be carried out before, during and after manufacture, the frequency with which they are to be carried out and the test equipment used; the correlation of calibration shall be ensured.

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

The assessment team must have prior experience in evaluating the technology in question. The assessment procedure shall include an inspection of the manufacturer's premises and, in duly justified cases, of the facilities of the manufacturer's suppliers or subcontractors, in order to inspect the processes of manufacturing.

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

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

The notified body shall evaluate the proposed amendments and check whether the quality system thus amended continues to comply with the requirements referred to in paragraph 3.2. It shall inform the manufacturer of its decision, including the findings of the inspection and a reasoned assessment.

4. Control: The provisions of paragraph 5 of Annex IV shall apply.

5. Verification of the processed products listed in List A of Annex II:

5.1 In the case of products listed in Annex II, List A, the manufacturer shall communicate to the notified body, without delay and after completion of the examinations or tests, the relevant protocols on the examinations. of products or lots of manufactured products. In addition, the manufacturer shall make available to the notified body the samples of products or batches of products manufactured in accordance with the conditions and modalities previously agreed.

5.2 The manufacturer may place the products on the market, except where the notified body informs it within the agreed time limit, which in any event shall not exceed 30 days from the receipt of the samples, a different decision, which may include, in particular, conditions for the validity of the certificates issued.

ANNEX VIII

Statement and procedures regarding products for performance evaluation

1. In the case of products for performance evaluation, the manufacturer or his authorised representative shall draw up the declaration with the information provided for in paragraph 2 and shall ensure that the relevant provisions of this Regulation are complied with. Royal Decree.

2. The declaration shall contain the following information:

-Data to identify the product in question.

-An assessment plan indicating, in particular, the objective, scientific, technical or medical justification, the scope of the assessment and the number of the products used.

-The relationship of laboratories or other institutions involved in the assessment study.

-The start date and the expected duration of the assessments and, in the case of self-diagnosis products, the place and number of profane involved.

-A declaration stating that the product in question complies with the requirements of this Royal Decree, irrespective of the aspects covered by the assessment and those specifically listed in the statement, and that all precautions have been taken to protect the health and safety of the patient, user or other persons.

3. The manufacturer shall also undertake to have at the disposal of the competent national authorities the documentation enabling the design, manufacture and operation of the product, including the expected operation, to be understood in such a way as to can assess compliance with the requirements of this Royal Decree. This documentation shall be kept for a period of at least five years from the end of the performance assessment.

The manufacturer shall take the necessary steps to ensure that the manufacturing process ensures that the products manufactured are in conformity with the documentation referred to in paragraph 1.

ANNEX IX

Criteria for the designation of notified bodies

1. The notified body, its director and the verification and evaluation staff may not be the designers, manufacturers, suppliers, installers or users of the products which inspect or the authorised representatives of any of the products concerned. persons. They must not intervene directly or as representatives in the design, construction, marketing or maintenance of the products. This does not in any way preclude the possibility of exchange of technical information between the manufacturer and the notified body.

2. The notified body and its staff shall carry out the assessment and verification operations with the highest degree of professional integrity and the necessary competence in the field of medical devices. They shall be free from any pressure and incitements, in particular economic order, which may affect their judgment or the results of the inspection, in particular by persons or groups of persons with interest in the results of the verifications.

In the event that the notified body subcontracts specific tasks related to the observation and verification of facts, it must first ensure that the subcontractor complies with the provisions of the Royal Decree. The notified body shall have at the disposal of the national authorities the documents relating to the assessment of the qualifications of the subcontractor and the work carried out by it in the field of this Royal Decree.

3. The notified body shall be capable of carrying out all the tasks assigned to these bodies by one of the Annexes III to VII and for which it has been notified, either by the body itself or under its responsibility. In particular, it shall have the necessary staff and resources to carry out in an appropriate manner the technical and administrative activities inherent in carrying out the evaluations and verifications. This implies the existence, within the organization, of sufficient scientific personnel who possess the appropriate experience and the necessary knowledge to evaluate the functional and the functional nature from the biological and health point of view. operation of the products for which it has been notified, in relation to the requirements of this Royal Decree and in particular with the requirements of Annex I. It shall also have access to the equipment necessary for the verifications required.

4. The staff responsible for the control must have:

-Strong professional training covering all the assessment and verification operations for which the body has been designated.

-A satisfactory knowledge of the rules regarding inspections that I carry out and a proper experience of these inspections.

-The ability to draw up certificates, minutes and reports to show that the inspections have been carried out.

5. The impartiality of the personnel carrying out the inspections shall be ensured. The remuneration of such staff shall not depend on the number of inspections carried out or on the results of such inspections.

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

7. The staff of the notified body shall be bound by professional secrecy with regard to any information which it has knowledge of in the performance of its tasks (except in relation to the competent administrative authorities of the State (Spanish) in the field of this Royal Decree or any provision of national law adopted pursuant to it.

ANNEX X

CE conformity marking

The CE conformity marking shall consist of the initials "CE" presented as follows:

Imagen: img/disp/2004/262/18571_001.png

-If the marking is reduced or extended, the proportions given in the graduated drawing shown above will be respected.

-The various components of the CE marking must basically have the same vertical dimension, which may not be less than 5 mm. This minimum size requirement may not be required for small products.