Regulation (EC) No 596/2009 of the European Parliament and of the CouncilShow full title

1.2. Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (1) U.K.

As regards Directive 98/79/EC, the Commission should be empowered in particular to adopt particular health monitoring measures and to amend Annex II. Since those measures are of general scope and are designed to amend non-essential elements of Directive 98/79/EC, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

When, on imperative grounds of urgency, the normal time-limits for the regulatory procedure with scrutiny cannot be complied with, the Commission should be able to have recourse to the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for the adoption of prohibitions, restrictions or particular requirements for certain products.

Accordingly, Directive 98/79/EC is hereby amended as follows:

1.

Article 7 shall be replaced by the following:

‘Article 7

1. The Commission shall be assisted by the Committee set up by Article 6(2) of Directive 90/385/EEC.

2. Where reference is made to this paragraph, Articles 5 and 7 of Council Decision 1999/468/EC(2) shall apply, having regard to the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

4. Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’;

2.

Article 10(5) shall be replaced by the following:

‘5. Member States shall take all necessary measures to ensure that the notifications referred to in paragraphs 1 and 3 are registered immediately in the databank described in Article 12.

The procedures for implementing this Article and in particular those referring to the notification and the concept of significant change shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).’;

3.

Article 11(5) shall be replaced by the following:

‘5. Member States shall on request inform the other Member States of the details referred to in paragraphs 1 to 4. The procedures implementing this Article shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).’;

4.

Article 12(3) shall be replaced by the following:

‘3. The procedures implementing this Article shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).’;

5.

Article 13 shall be replaced by the following:

‘Article 13

Where a Member State considers, in relation to a given product or group of products, that, in order to ensure protection of health and safety and/or to ensure that public health requirements are observed pursuant to Article 36 of the Treaty, the availability of such products should be prohibited, restricted or made subject to particular requirements, it may take any necessary and justified transitional measures. It shall then inform the Commission and all the other Member States, giving the reasons for its decision. The Commission shall consult the interested parties and the Member States and, where the national measures are justified, adopt necessary Community measures.

Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 7(4).’;

6.

Article 14(1) shall be replaced by the following:

‘1. Where a Member State considers that:

(a) the list of devices in Annex II should be amended or extended; or

(b) the conformity of a device or category of devices should be established, by way of derogation from the provisions of Article 9, by applying one or more given procedures taken from amongst those referred to in Article 9,

it shall submit a duly substantiated request to the Commission and ask it to take the necessary measures.

Where those measures concern matters referred to in point (a), designed to amend non-essential elements of this Directive, they shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3).

Where those measures concern matters referred to in point (b), they shall be adopted in accordance with the regulatory procedure referred to in Article 7(2).’.

(1)

OJ L 331, 7.12.1998, p. 1.

(2)

OJ L 184, 17.7.1999, p. 23.’;