S.L. 427.44 Art. 6Conformity assessment procedures.

(1) In the case of devices falling within Class III, other than devices which are custom-made or intended for clinical investigations, the manufacturer shall, in order to affix the CE

marking, either:

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

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

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

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

(2) In the case of devices falling within Class IIa, other than devices which are custom-made or intended for clinical investigations, the manufacturer shall, in order to affix the CE marking, follow the procedure relating to the EC declaration of conformity set out in Schedule VII, coupled with either:

(a) the procedure relating to the EC verification set out in Schedule IV; or

(b) the procedure relating to the EC declaration of conformity set out in Schedule V relating to production quality assurance;

(c) the procedure relating to the EC declaration of conformity set out in Schedule VI relating to product quality assurance. Instead of applying these procedures, the manufacturer may also follow the procedure referred to in sub-regulation (3)(a).

(3) In the case of devices falling within Class IIb, other than devices which are custom-made or intended for clinical investigations, the manufacturer shall, in order to affix the CE marking, either:

(a) follow the procedure relating to the EC declaration of conformity set out in Schedule II relating to full quality assurance; in this case, section 4 of Schedule II is not applicable; or

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

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

(ii) the procedure relating to the EC declaration of conformity set out in Schedule V relating to production quality assurance; or

(iii) the procedure relating to the EC declaration of conformity set out in Schedule VI relating to product quality assurance.

(4) In the case of devices falling within Class I, other than devices which are custom-made or intended for clinical investigations, the manufacturer shall, in order to affix the CE marking, follow the procedure referred to in Schedule VII and draw up the EC declaration of conformity required before placing the device on the market.

(5) In the case of custom-made devices, the manufacturer shall follow the procedure referred to in Schedule VIII and draw up the statement set out in that Schedule before placing each device on the market. The manufacturer of such devices may be requested to submit a list of devices which have been into service in Malta to the Medicines Authority.

(6) 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.

(7) The manufacturer may instruct his authorised representative to initiate the procedures provided for in Schedules III, IV, VII and VIII.

(8) 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.

(9) 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.

(10) Decisions taken by the notified bodies in accordance with Schedules II, III, V and VI 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.

(11) The records and correspondence relating to the procedures referred to in sub-regulations (1) to (5) shall be in the Maltese or English language or in another Community language acceptable to the notified body.

(12) By derogation from sub-regulations (1) to (5), the Medicines Authority, after consulting 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) to (5) have not been carried out and the use of which is in the interest of protection of health.