S.L. 427.44 ст. 13Notified bodies.

(1) The Medicines Authority shall notify the Commission and other Member States of the bodies which it has designated for carrying out the tasks pertaining to the procedures referred to in regulation 6(1) to (12) and the specific tasks for which the bodies have been designated.

(2) The Medicines Authority shall apply the criteria set out in Schedule XI for the designation of bodies. Bodies that meet the criteria laid down in the national standards which transpose the relevant harmonised standards shall be presumed to meet the relevant criteria.

(3) The Medicines Authority shall withdraw the notification referred to in sub-regulation (1) if it finds that the body no longer meets the criteria referred to in sub-regulation (2). It shall immediately inform the other Member States and the Commission thereof.

(4) The notified body and the manufacturer, or his authorised representative, shall lay down, by common accord, the time limits for completion of the assessment and verification operations referred to in Schedules II to VI.

(5) (a) The notified body shall inform the Regulatory Affairs Directorate about all certificates issued, modified, supplemented, suspended, withdrawn or refused and the other notified bodies within the scope of these regulations about certificates suspended, withdrawn or refused and, on request, about certificates issued.

(b) The notified body shall also make available, on request, all additional relevant information.

(6) (a) Where a notified body finds that pertinent requirements of these regulations have not been met or are no longer met by the manufacturer or where a certificate should not have been issued, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate issued or place any restrictions on it unless compliance with such requirements is ensured by the implementation of appropriate corrective measures by the manufacturer.

(b) In the case of suspension or withdrawal of the certificate or of any restriction placed on it or in cases where an intervention of the competent authority may become necessary, the notified body shall inform the Regulatory Affairs Directorate thereof. The Regulatory Affairs Directorate shall inform the other Member States and the Commission.

(7) The notified body shall, on request, supply all relevant information and documents including budgetary documents, required to enable the Regulatory Affairs Directorate to verify compliance with the requirements of Schedule XI to these regulations.

(8) All necessary actions shall be taken to ensure that the notified bodies which are responsible pursuant to regulation 6(1) to

(4) for conformity assessment take account of any relevant information regarding the characteristics and performance of such devices, including in particular the results of any relevant tests and verification already carried out under pre-existing Maltese law, regulations or administrative provisions in respect of such devices.