Article 9
Directive 90/385/EEC is hereby amended as follows: 1. throughout the text, the term 'EC mark' is replaced by 'CE marking'; 2. in Article 4 the first paragraph is replaced by the following text: '1. Member States shall not prevent the placing on the market or the putting into service within their territory of devices complying with the provisions of this Directive and bearing the CE marking provided for in Article 12 which indicate that they have been the subject of an evaluation of their conformity in accordance with Article 9.'; 3. the following paragraph is added to Article 4: '5. (a) Where the devices are subject to other Directives concerning other aspects and which also provide for the affixing of the CE marking, the latter shall indicate that the devices are also presumed to conform to the provisions of the other Directives. (b) However, where one or more of these Directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the CE marking shall indicate conformity to the provisions only of those Directives applied by the manufacturer. In this case, particulars of the Directives applied, as published in the Official Journal of the European Communities, must be given in the documents, notices or instructions required by the Directives and accompanying such devices; these documents, notices or instructions shall be accessible without it being necessary to destroy the packaging which keeps the device sterile.'; 4. in Article 11 the first paragraph is replaced by the following text: '1. Member States shall notify the Commission and the other Member State of the bodies which they have appointed to carry out the procedures referred to in Article 9 together with the specific tasks which these bodies have been appointed to carry out and the identification numbers assigned to them beforehand by the Commission. The Commission shall publish in the Official Journal of the European Communities a list of the notified bodies and their identification numbers and the tasks for which they have been notified. The Commission shall ensure that this list is kept up to date.'; 5. in Article 12 (2) the second subparagraph is replaced by the following text: 'It must be followed by the identification number of the notified body responsible for implementation of the procedures set out in Annexes 2, 4 and 5.'; 6. in Article 12 the third paragraph is replaced by the following text: '3. The affixing of markings on the devices which are likely to deceive third parties as to the meaning and form of the CE marking shall be prohibited. Any other marking may be affixed to the packaging or to the instruction leaflet accompanying the device provided that the visibility and legibility of the CE marking is not hereby reduced.'; 7. Article 13 is replaced by the following text: 'Article 13 Without prejudice to Article 7 (a) where a Member State establishes that the CE marking has been affixed unduly, the manufacturer or his authorized representative established within the Community shall be obliged to end the infringement under conditions imposed by the Member State; (b) where non-compliance continues, the Member State must take all appropriate measures to restrict or prohibit the placing on the market of the device in question or to ensure that it is withdrawn from the market in accordance with the procedures laid down in Article 7.'; 8. Annex II is amended as follows: (a) in section 2 the second paragraph is replaced by the following text: 'The manufacturer or his authorized representative established within the Community shall affix the CE marking in accordance with Article 12 and shall draw up a written declaration of conformity. This declaration shall cover one or more identified examples of the product and shall be kept by the manufacturer or his authorized representative established within the Community. The CE marking shall be accompanied by the identification number of the notified body responsible.'; (b) section 6 is replaced by the following text: '6. Administrative provisions 6.1. For at least five years from last date of manufacture of the product, the manufacturer shall keep available for the national authorities: - the declaration of conformity, - the documentation referred to in the second indent of section 3.1, - the amendments referred to in section 3.4, - the documentation referred to in section 4.2, - the decisions and reports of the notified body referred to in sections 3.4, 4.3, 5.3 and 5.4. 6.2. On request, the notified body shall make available to the other notified bodies and the competent authority all relevant information on approvals of quality systems issued, refused or withdrawn. 6.3. Where neither the manufacturer nor his authorized representative are established in the Community, the task of keeping available for the authorities the technical documentation referred to in Article 4 (2) shall fall to the person responsible for placing the appliance on the Community market.'; 9. in Annex III sections 7 and 8 are replaced by the following text: '7. Administrative provisions 7.1. On request, each notified body shall make available to the other notified bodies and the competent authority, all relevant information on EC type-examination certificates and addenda issued, refused or withdrawn. 7.2. Other notified bodies may obtain a copy of the EC type-examination certificates and/or the addenda to them. The annexes to the certificates shall be made available to the other notified bodies when a reasoned application is made and after the manufacturer has been informed. 7.3. The manufacturer or his authorized representative shall keep with the technical documentation a copy of the EC type-examination certificates and the supplements to them for a period of at least five years from the manufacture of the last appliance. 7.4. Where neither the manufacturer nor his authorized representative are established in the Community, the task of keeping the technical documentation available for the authorities shall fall to the person responsible for placing the appliance concerned on the Community market.'; 10. Annex IV is replaced by the following text: 'ANNEX IV EC VERIFICATION 1. EC verification is the procedure whereby the manufacturer or his authorized representative established within the Community ensures and declares that the products subject to the provisions of section 3 are in conformity with the type as described in the EC type-examination certification and satisfy the requirements of this Directive that apply to them. 2. The manufacturer or his authorized representative established within the Community shall take all measures necessary in order that the manufacturing process ensures conformity of the products to the type as described in the EC type-examination certification and to the requirements of this Directive that apply to them. The manufacturer or his authorized representative established within the Community shall affix the CE marking to each product and draw up a written declaration of conformity. 3. The manufacturer shall, before the start of manufacture, prepare documents defining the manufacturing processes, in particular as regards sterilization, together with all the routine, pre-established provisions to be implemented to ensure uniformity of production and conformity of the products with the type as described in the EC type-examination certificate as well as with the relevant requirements of this Directive. 4. The manufacturer shall undertake to institute and keep updated a post-marketing surveillance system. This undertaking shall include the obligation on the part of the manufacturer to notify the competent authorities of the following events immediately on learning of them: (i) any change in the characteristics or performances and any inaccuracies in the instruction leaflet for a device which might lead to or have led to the death of a patient or deterioration in his state of health; (ii) any technical or medical reason resulting in the withdrawal of a device from the market by a manufacturer. 5. The notified body shall carry out the appropriate examinations and tests in order to check the conformity of the product to the requirements of this Directive by examination and testing of products on a statistical basis, as specified in section 6. The manufacturer must authorize the notified body to evaluate the efficiency of the measures taken pursuant to section 3, by audit where appropriate. 6. Statistical verification 6.1. Manufacturers shall present the products manufactured in the form of uniform batches and shall take all necessary measures in order that the manufacturing process ensures the uniformity of each batch produced. 6.2. A random sample shall be taken from each batch. Products in a sample shall be individually examined and appropriate tests, as set out in the standard(s) referred to in Article 5, or equivalent tests shall be carried out to verify their conformity to the type as described in the EC type-examination certificate and thereby determine whether a batch is to be accepted or rejected. 6.3. Statistical control of products shall be based on attributes, entailing a sampling system with the following characteristics: - a level of quality corresponding to a probability of acceptance of 95 %, with a non-conformity percentage of between 0,29 and 1 %, - a limit quality corresponding to a probability of acceptance of 5 %, with a percentage of non-conformity of between 3 and 7 %. 6.4. Where batches are accepted, the notified body shall affix, or cause to be affixed, its identification number to each product and draw up a written certificate of conformity relating to the tests carried out. All products in the batch may be placed on the market except for those products from the sample which were found not to be in conformity. Where a batch is rejected, the notified body shall take appropriate measures to prevent the placing on the market of that batch. In the event of frequent rejection of batches the notified body may suspend the statistical verification. The manufacturer may, under the responsibility of the notified body, affix the latter's identification number during the manufacturing process. 6.5. The manufacturer or his authorized representative shall ensure that he is able to supply the notified body's certificates of conformity on request.'; 11. the second subparagraph of section 2 of Annex V is replaced by the following text: 'The manufacturer or his authorized representative established within the Community shall affix the CE marking in accordance with Article 12 and draw up a written declaration of conformity. This declaration shall cover one or more identified specimens of the product and shall be kept by the manufacturer. The CE marking shall be accompanied by the identification number of the notified body responsible.'; 12. Annex IX is replaced by the following text: 'ANNEX IX CE CONFORMITY MARKING - The CE conformity marking shall consist of the initials "CE " taking the following form: - If the CE marking is reduced or enlarged the proportions given in the above graduated drawing must be respected. - The various components of the CE marking must have substantially the same vertical dimension, which may not be less than 5 mm. This minimum dimension may be waived for small-scale devices.'