Which strategy should be applied for the Conformity Assessment process? Which Annex(es) apply to my product?
Council Directive 90/385/EEC
(5 September 2007)
1. In the case of devices other than those which are custom-made or intended for clinical investigations, the manufacturer must, in order to affix the CE marking at his own choice:
(a) follow the procedure relating to the EC declaration of conformity set out in Annex 2; or
(b) follow the procedure relating to EC type-examination set out in Annex 3, coupled with:
(i) the procedure relating to EC verification set out in Annex 4, or
(ii) the procedure relating to the EC declaration of conformity to type set out in Annex 5.
2. In the case of custom-made devices, the manufacturer must draw up the declaration provided for in Annex 6 before placing each device on the market.
3. Where appropriate, the procedures provided for in Annexes 3, 4 and 6 may be discharged by the manufacturer’s authorized representative established in the Community.
4. The records and correspondence relating to the procedures referred to in paragraphs 1, 2 and 3 shall be in an official language of the Member State in which the said procedures will be carried out and/or in a language acceptable to the notified body defined in Article 11.
5. During the conformity assessment procedure for a device, the manufacturer and/or the notified body shall take account of the results of any assessment and verification operations which, where appropriate, have been carried out in accordance with this Directive at an intermediate stage of manufacture.
6. Where the conformity assessment procedure involves the intervention of a notified body, the manufacturer, or his authorized representative established in the Community, may apply to a body of his choice within the framework of the tasks for which the body has been notified.
7. The notified body may require, where duly justified, any information or data which is necessary for establishing and maintaining the attestation of conformity in view of the chosen procedure.
8. Decisions taken by the notified bodies in accordance with Annexes 2, 3 and 5 shall be valid for a maximum of five years and may be extended on application, made at a time agreed in the contract signed by both Parties, for further periods of a maximum length of five years.
9. By derogation from paragraphs 1 and 2 the competent authorities may authorize, on duly justified request, the placing on the market and putting into service, within the territory of the Member State concerned, of individual devices for which the procedures referred to in paragraphs 1 and 2 have not been carried out and the use of which is in the interest of protection of health.
10. The measures designed to amend non-essential elements of this Directive, inter alia by supplementing it, relating to the means by which, in the light of technical progress and considering the intended users of the devices concerned, the information laid down in Annex 1 Section 15 may be set out shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 6(4).
1. A Member State shall submit a duly substantiated request to the Commission and ask it to take the necessary measures in the following situations:
- that Member State considers that the conformity of a device or family of devices should be established, by way of derogation from the provisions of Article 9, by applying solely one of the given procedures chosen from among those referred to in Article 9,
- that Member State considers that a decision is required as to whether a particular product or product group falls within the definition of Article 1(2)(a), (c), (d) or (e).
1. Where measures are deemed necessary pursuant to the first subparagraph of this paragraph they shall be adopted in accordance with the regulatory procedure referred to in Article 6(3).
2. The Commission shall inform the Member States of the measures taken.