S.L. 427.44 Art. 10Withdrawal and prohibition from market.

(1) Where it is ascertained that the devices referred to in regulation 5(8) and (9)(b), when correctly installed, maintained and used for their intended purpose, may compromise the health and, or safety of patients, users or, where applicable, other persons, all appropriate interim measures shall be taken by the Medicines Authority to withdraw such devices from the market or prohibit or restrict their being placed on the market or put into service.

(2) If a device which is not in conformity with the relevant requirements bears the CE marking, all appropriate measures shall be taken with regard to those responsible for affixing the marking.

(3) The Medicines Authority shall take the necessary steps to ensure that any information brought to his knowledge, in accordance with the provisions of these regulations, regarding the incidents mentioned below involving a Class I, IIa, IIb or III device is recorded and evaluated centrally:

(a) any malfunction or deterioration in the characteristics and, or performance of a device, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;

(b) any technical or medical reason in relation to the characteristics or performance of a device for the reasons referred to in paragraph (a), leading to a systematic recall of devices of the same type by the manufacturer.

(4) The Medicines Authority shall be immediately informed of any such measures taken under sub-regulations (1) to (3), indicating the reasons for such decision and, in particular, whether non-compliance is due to:

(a) failure to satisfy the essential requirements referred to in regulation 5(1);

(b) incorrect application of the standards referred to in regulation 5(6), in so far as it is claimed that the standards have been applied;

(c) shortcomings in the standards themselves.

(5) (a) The necessary steps shall be taken to ensure that the manufacturer of the device concerned, or his authorised representative, is also informed of the incidents referred to in sub-regulation (3).

(b) An assessment of the incidents mentioned in sub-regulation (3) will be carried out by the Medicines Authority, if possible together with the manufacturer or his authorised representative.

(6) Any decision taken pursuant to these regulations -

(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 decisions 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 Maltese law and of the time limits to which such remedies are subject.

(7) In the event of a decision as referred to in sub-regulation (6), the manufacturer shall have an opportunity to put forward his viewpoint in advance, unless such consultation is not possible because of the urgency of the measure to be taken.

(8) Where the Medicines Authority considers, in relation to a given product or group of products, that, in order to ensure the 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, any necessary and justified transitional measures may be taken. The Medicines Authority shall immediately inform the Commission and all other Member States of any measures taken in pursuance of sub-regulations (1) to (10), giving the reasons for such decisions..

(9) Without prejudice to sub-regulations (1), (2) and (4):

(a) where it is established that the CE marking has been affixed unduly or is missing in violation of these regulations, the manufacturer or his authorised representative shall be obliged to end the infringement under conditions imposed by the Medicines Authority; and

(b) where non-compliance continues, all appropriate measures shall be taken by the Medicines Authority to restrict or prohibit the placing on the market of the product in question or to ensure that it is withdrawn from the market, in accordance with the procedure as laid down in sub-regulations (1), (2) and (4).

(10) The provisions of sub-regulation (9) shall also apply where the CE marking has been affixed in accordance with the procedures in these regulations, but inappropriately, on products that are not covered by these regulations.