S.L. 427.10 Art. 6Conformity assessment procedures.

(1) In the case of devices other than those which are custom-made or intended for clinical investigations, the manufacturer must, in order to affix the CE marking, at his own choice:

(a) follow the procedure relating to the EC declaration of conformity set out in Schedule II; or

(b) follow the procedure relating to the EC type-examination set out in Schedule III, coupled with:

(i) the procedure relating to EC verification set out in Schedule IV, or

(ii) the procedure relating to the EC declaration of conformity to type set out in Schedule V.

(2) In the case of custom-made devices, the manufacturer must draw up the declaration provided for in Schedule VI before placing each device on the market.

(3) Where appropriate, the procedures provided for in Schedule III, IV and VI may be discharged by the manufacturer’s authorised representative.

(4) The records and correspondence relating to the procedures referred to in sub-regulations (1), (2) and (3) shall be in, at least, Maltese and, or English, and, or in a language acceptable to the notified body defined in regulation 11(1) to (7).

(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 these regulations at an intermediate stage of manufacture.

(6) Where the conformity assessment procedure involves the intervention of a notified body, the manufacturer, or his authorised representative, 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 Schedules II, III and V 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 a maximum length of five years.

(9) By derogation from sub-regulations (1) and (2), the Medicines Authority, after consultation with the Superintendent of Public Health, may authorise, on duly justified request, the placing on the market and putting into service, within the Maltese territory, of individual devices for which the procedures referred to in sub-regulations (1) and (2) have not been carried out and the use of which is in the interest of protection of health.

(10) The Medicines Authority shall submit a duly substantiated request to the Commission and ask it to take the necessary measures in the following situations:

(a) the Maltese authorities consider that the conformity of a device or family of devices should be established, by way of derogation from the provisions of sub-regulations (1) to (9), by applying solely one of the given procedures chosen from among those referred to in sub-regulations (1) to (9);

(b) the Maltese authorities consider that a decision is required as to whether a particular product or product group falls within the definition of "active implantable medical device", "custom-made device", "device intended for clinical investigation" or "medical device".