Can medical devices that have undergone a positive Conformity Assessment be removed from the market by the Competent Authorities? Role of the Authorized Representative before the Member State Competent Authorities and before the European Commission.
Council Directive 90/385/EEC
(5 September 2007)
1. Where a Member State finds that the devices referred to in Article 1 (2) (c) and (d), correctly put into service and used in accordance with their intended purpose, may compromise the health and/or safety of patients, users or, where applicable, other persons, it shall take all appropriate measures to withdraw such devices from the market or prohibit or restrict their being placed on the market or their being put into service.
The Member State shall immediately inform the Commission of any such measure, indicating the reasons for its decision and, in particular, whether non-compliance with this Directive is due to:
(a) failure to meet the essential requirements referred to in Article 3, where the device does not meet in full or in part the standards referred to in Article 5;
(b) incorrect application of those standards;
(c) shortcomings in the standards themselves.
2. The Commission shall enter into consultation with the parties concerned as soon as possible. Where, after such consultation, the Commission finds that:
- the measures are justified, it shall immediately so inform the Member State which took the initiative and the other Member States; where the decision referred to in paragraph 1 is attributed to shortcomings in the standards, the Commission shall, after consulting the parties concerned, bring the matter before the Committee referred to in Article 6 (1) within two months if the Member State which has taken the decision intends to maintain it and shall initiate the procedures referred to in Article 6 (1),
- the measures are unjustified, it shall immediately so inform the Member State which took the initiative and the manufacturer or his authorized representative established within the Community.
3. Where a device which does not comply bears the CE marking, the competent Member State shall take appropriate action against whomsoever has affixed the mark and shall inform the Commission and the other Member States thereof.
4. The Commission shall ensure that the Member States are kept informed of the progress and outcome of this procedure.
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, such products should be withdrawn from the market, or their placing on the market and putting into service should be prohibited, restricted or subjected to particular requirements, it may take any necessary and justified transitional measures.
The Member State shall then inform the Commission and all the other Member States of the transitional measures, giving the reasons for its decision.
The Commission shall, whenever possible, consult the interested Parties and the Member States. The Commission shall adopt its opinion, indicating whether the national measures are justified or not. The Commission shall inform all the Member States and the consulted interested Parties.
When appropriate, the necessary measures designed to amend non-essential elements of this Directive, by supplementing it, relating to withdrawal from the market, prohibition of placing on the market and putting into service of a certain product or group of products or to restrictions or introduction of particular requirements therefor, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 6(4). On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 6(5).
Any decision taken pursuant to this Directive
(a) to refuse or restrict the placing on the market or the putting into service of a device or the carrying out of clinical investigations; or
(b) to withdraw devices from the market
shall state the exact grounds on which it is based. Such a decision shall be notified without delay to the party concerned, who shall at the same time be informed of the remedies available to him under the laws in force in the Member State in question and of the time limits to which such remedies are subject.
In the event of a decision as referred to in the previous paragraph the manufacturer, or his authorized representative, 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.