CA Process
Class I:
Annex VII (EC Declaration of Conformity)
Class I (sterile or with measuring function):
Annex VII (EC Declaration of Conformity) coupled with either
- Anex II (Full Quality Assurance), or
- Annex V (Production Quality Assurance).
The application of these Annexes and Notified Body intervention being limited to those aspects of manufacture concerned with securing and maintaining sterile conditions, respectively conformity of products with metrological requirements.
Class IIa:
Annex VII (EC Declaration of Conformity) coupled with either
- Annex IV (EC Verification), or
- Annex V (Production Quality Assurance), or
- Annex VI (Product Quality Assurance);
alternately, SOLELY Annex II (Full Quality Assurance System) may be applied without application of Section 4.
Class IIb:
Annex III (EC Type Examination) coupled with either
- Annex IV (EC Verification), or
- Annex V (Production Quality Assurance), or
- Annex VI (Product Quality Assurance);
alternately, SOLELY Annex II (Full Quality Assurance System) may be applied without application of Section 4.
Class III:
Annex III (EC Type Examination) coupled with either
- Annex IV (EC Verification), or
- Annex V (Production Quality Assurance);
alternately SOLELY Annex II (Full Quality Assurance System) may be fully applied.
(5 September 2007)
Article 11
Conformity assessment procedures
1. In the case of devices falling within Class III, other than devices which are custom-made or intended for clinical investigations, the manufacturer shall, in order to affix the CE marking, either:
- follow the procedure relating to the EC declaration of conformity set out in Annex II (full quality assurance); or
- follow the procedure relating to the EC type-examination set out in Annex III, coupled with:
- the procedure relating to the EC verification set out in AnnexIV or
- the procedure relating to the EC declaration of conformity set out in Annex V (production quality assurance).
2. In the case of devices falling within Class IIa, other than devices which are custom-made or intended for clinical investigations, the manufacturer shall, in order to affix the CE marking, follow the procedure relating to the EC declaration of conformity set out in Annex VII, coupled with either:
- the procedure relating to the EC verification set out in Annex IV; or
- the procedure relating to the EC declaration of conformity set out in Annex V (production quality assurance); or
- the procedure relating to the EC declaration of conformity set out in Annex VI (product quality assurance).
Instead of applying these procedures, the manufacturer may also follow the procedure referred to in paragraph 3 (a).
3. In the case of devices falling within Class IIb, other than devices which are custom-made or intended for clinical investigations, the manufacturer shall, in order to affix the CE marking, either:
- follow the procedure relating to the EC declaration of conformity set out in Annex II (full quality assurance); in this case, point 4 of Annex II is not applicable; or
- follow the procedure relating to the EC type-examination set out in Annex III, coupled with:
- the procedure relating to the EC verification set out in Annex IV; or
- the procedure relating to the EC declaration of conformity set out in Annex V (production quality assurance); or
- the procedure relating to the EC declaration of conformity set out in Annex VI (product quality assurance).
4. The Commission shall, no later than five years from the date of implementation of this Directive, submit a report to the Council on the operation of the provisions referred to in Article 10 (1), Article 15 (1), in particular in respect of Class I and Class IIa devices, and on the operation of the provisions referred to in Annex II, Section 4.3 second and third subparagraphs and in Annex III, Section 5 second and third subparagraphs to this Directive, accompanied, if necessary, by appropriate proposals.
5. In the case of devices falling within Class I, other than devices which are custom-made or intended for clinical investigations, the manufacturer shall, in order to affix the CE marking, follow the procedure referred to in Annex VII and draw up the EC declaration of conformity required before placing the device on the market.
6. In the case of custom-made devices, the manufacturer shall follow the procedure referred to in Annex VIII and draw up the statement set out in that Annex before placing each device on the market.
Member States may require that the manufacturer shall submit to the competent authority a list of such devices which have been put into service in their territory.
7. 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.
8. The manufacturer may instruct his authorized representative to initiate the procedures provided for in Annexes III, IV, VII and VIII.
9. Where the conformity assessment procedure involves the intervention of a notified body, the manufacturer, or his authorized representative, may apply to a body of his choice within the framework of the tasks for which the body has been notified.
10. 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.
11. Decisions taken by the notified bodies in accordance with Annexes II, III, V and VI 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.
12. The records and correspondence relating to the procedures referred to in paragraphs 1 to 6 shall be in an official language of the Member State in which the procedures are carried out and/or in another Community language acceptable to the notified body.
13. By derogation from paragraphs 1 to 6, 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 to 6 have not been carried out and the use of which is in the interest of protection of health.
14. The measures designed to amend non-essential elements of this Directive, 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 I Section 13.1 may be set out, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3).
Article 12
Particular procedure for systems and procedure packs
1. By way of derogation from Article 11 this Article shall apply to systems and procedure packs.
2. Any natural or legal person who puts devices bearing the CE marking together within their intended purpose and within the limits of use specified by their manufacturers, in order to place them on the market as a system or procedure pack, shall draw up a declaration by which he states that:
(a) he has verified the mutual compatibility of the devices in accordance with the manufacturers' instructions and has carried out his operations in accordance with these instructions; and
(b) he has packaged the system or procedure pack and supplied relevant information to users incorporating relevant instructions from the manufacturers; and
(c) the whole activity is subjected to appropriate methods of internal control and inspection.
Where the conditions above are not met, as in cases where the system or procedure pack incorporate devices which do not bear a CE marking or where the chosen combination of devices is not compatible in view of their original intended use, the system or procedure pack shall be treated as a device in its own right and as such be subjected to the relevant procedure pursuant to Article 11.
3. Any natural or legal person who sterilized, for the purpose of placing on the market, systems or procedure packs referred to in paragraph 2 or other CE-marked medical devices designed by their manufacturers to be sterilized before use, shall, at his choice, follow one of the procedures referred to in Annex II or V. The application of the abovementioned Annexes and the intervention of the notified body are limited to the aspects of the procedure relating to the obtaining of sterility. The person shall draw up a declaration stating that sterilization has been carried out in accordance with the manufacturer's instructions.
4. The products referred to in paragraphs 2 and 3 themselves shall not bear an additional CE marking. They shall be accompanied by the information referred to in point 13 of Annex I which includes, where appropriate, the information supplied by the manufacturers of the devices which have been put together. The declaration referred to in paragraphs 2 and 3 above shall be kept at the disposal of competent authorities for a period of five years.
Article 13
Decisions with regard to classification, derogation clause
1. Where a Member State considers that:
(a) application of the classification rules set out in Annex IX requires a decision with regard to the classification of a given device or category of devices; or
(b) a given device or family of devices should be classified, by way of derogation from the provisions of Annex IX, in another class; or
(c) the conformity of a device or family of devices should be established, by way of derogation from the provisions of Article 11, by applying solely one of the given procedures chosen from among those referred to in Article 11, it shall submit a duly substantiated request to the Commission and ask it to take the necessary measures. These measures shall be adopted in accordance with the procedure referred to in Article 7 (2).
2. The Commission shall inform the Member States of the measures taken and, where appropriate, publish the relevant parts of these measures in the Official Journal of the European Communities.
