S.L. 427.44 Art. 2Scope and classification.

(1) These regulations shall apply to medical devices and their accessories as follows:

(a) for the purposes of these regulations, accessories shall be treated as medical devices in their own right; and

(b) both medical devices and accessories shall hereinafter be termed "devices".

(2) (a) Devices shall be divided into Classes I, IIa, IIb and III. Classification shall be carried out in accordance with Schedule IX. In the event of a dispute between the manufacturer and the notified body concerned, resulting from the application of the classification rules, the matter shall be referred for decision to the Medicines Authority if the notified body is designated in Malta.

(b) By way of derogation from the rules set out in Schedule IX, breast implants shall be reclassified as medical devices falling within Class III. By way of derogation from the rules set out in Schedule IX, hip, knee and shoulder replacements shall be reclassified as medical devices falling within Class III.

(c) When it is considered that -

(i) application of the classification rules set out in Schedule IX requires a decision with regard to the classification of a given device or category of devices; or

(ii) a given device or family of devices should be classified, by way of derogation from the provisions of Schedule IX, in another class; or

(iii) the conformity of a device or family of devices should, by way of derogation from article 6, be established by applying solely one of the given procedures chosen from among those referred to in article 6 of these regulations; or

(iv) a decision is required as to whether a particular product or product group falls within one of the definitions for "accessory", "custom-made device", "device intended for clinical investigations", "in diagnostic medical vitro device" or "medical device" in article 3, the Medicines Authority shall submit a duly substantiated request to the Commission and ask it to take the necessary measures.

(3) (a) For the purposes of these regulations, the Medicines Authority will act as Malta’s national competent authority in terms of the Committee referred to in Article 6 of Directive 93/42/EEC and with respect to the exchange of information, necessary to enable these regulations to be applied uniformly, with other Member States and the Commission.

(b) For the purposes of these regulations, the Medicines Authority will act as Malta’s national competent authority with respect to exchange of experience organised by the Commission in order to coordinate the uniform application of these regulations.