Medical Device Conformity Assessment Options?

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Display: Class I Medical Devices Display: Class I (Sterile or Measuring Function)
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Display: Clinical Investigation & Custom-Made Devices

CA Process
Which strategy should be applied for the Conformity Assessment process? Which Annex(es) apply to my product?

COUNCIL DIRECTIVE 93/42/EEC
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:

(a) follow the procedure relating to the EC declaration of conformity set out in Annex II (full quality assurance); or
(b) follow the procedure relating to the EC type-examination set out in Annex III, coupled with:

(i) the procedure relating to the EC verification set out in Annex IV;or
(ii) 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:

(a) the procedure relating to the EC verification set out in Annex IV; or
(b) the procedure relating to the EC declaration of conformity set out in Annex V (production quality assurance); or
(c) 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:

(a) 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
(b) follow the procedure relating to the EC type-examination set out in Annex III, coupled with:

(i) the procedure relating to the EC verification set out in Annex IV; or
(ii) the procedure relating to the EC declaration of conformity set out in Annex V (production quality assurance); or
(iii) 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 and procedure for sterilisation

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 sterilises, 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 sterilised 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 until the sterile package is opened or damaged. The person shall draw up a declaration stating that sterilisation 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 declarations referred to in paragraphs 2 and 3 shall be kept at the disposal of the competent authorities for a period of five years. 

Article 12a
Reprocessing of medical devices

The Commission shall, no later than 5 September 2010, submit a report to the European Parliament and to the Council on the issue of the reprocessing of medical devices in the Community.

In the light of the findings of this report, the Commission shall submit to the European Parliament and to the Council any additional proposal it may deem appropriate in order to ensure a high level of health protection.

Article 13
Decisions with regard to classification and derogation clause

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:

(a) that Member State considers that the 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;
(b) that Member State considers that a given device or family of devices should, by way of derogation from the provisions of Annex IX, be classified in another class;
(c) that Member State considers that the conformity of a device or family of devices should, by way of derogation from Article 11, be established by applying solely one of the given procedures chosen from among those referred to in Article 11;
(d) that Member State considers that a decision is required as to whether a particular product or product group falls within one of the definitions in Article 1(2)(a) to (e).

1.  The measures referred to in the first subparagraph of this paragraph shall, as appropriate, 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.