Council Directive 93/42/EECDangos y teitl llawn

Article 21 U.K. Repeal and amendment of Directives

1. Directive 76/764/EEC is hereby repealed with effect from 1 January 1995.

2. In the title and Article 1 of Directive 84/539/EEC, ‘human or’ is deleted.

In Article 2 of Directive 84/539/EEC, the following subparagraph is added to paragraph 1:

‘If the appliance is at the same time a medical device within the meaning of Directive 93/42/EEC(1) and if it satisfies the essential requirements laid down therein for that device, the device shall be deemed to be in conformity with the requirements of this Directive.’

3. Directive 90/385/EEC is hereby amended as follows:

1.

in Article 1 (2) the following two subparagraphs are added:

‘(h)

“placing on the market” means the first making available in return for payment or free of charge of a device other than a device intended for clinical investigation, with a view to distribution and/or use on the Community market, regardless of whether it is new or fully refurbished;

(i)

“manufacturer” means the natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party.

The obligations of this Directive to be met by manufacturers also apply to the natural or legal person who assembles, packages, processes, fully refurbishes and/or labels one or more ready-made products and/or assigns to them their intended purpose as a device with a view to their being placed on the market under his own name. This subparagraph does not apply to the person who, while not a manufacturer within the meaning of the first subparagraph, assembles or adapts devices already on the market to their intended purpose for an individual patient;’

2.

in Article 9 the following paragraphs are added:

‘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 II and III 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 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.’;

3.

the following Article 9a is inserted after Article 9:

‘Article 9a

1. Where a 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, 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) of Directive 93/42/EEC(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.’

4.

Article 10 shall be amended as follows:

• the following subparagraph shall be added to paragraph 2:

  ‘Member States may however authorize manufacturers to start the clinical investigations in question before the expiry of the 60-day period, provided that the Ethical Committee concerned has delivered a favourable opinion with respect to the investigation programme in question.’,

• the following paragraph shall be inserted:

  ‘2a. The authorization referred to in the second subparagraph of paragraph 2 may be subject to approval by the competent authority.’;

5.

the following is added to Article 14:

‘In the event of a decision as referred to in the previous paragraph the manufacturer, or his authorized representative established in the Community, shall have an opportunity to put forward his viewpoint in advance, unless such consultation is not possible because of the urgency of the measures to be taken.’

(1)

OJ No L 169, 12.7.1993, p. 1.’

(2)

OJ No L 169, 12.7.1993, p. 1.’