S.L. 427.30 Art. 16Notification of notified bodies procedure. S.L. 427.45 S.L. 427.45 S.L. 427.45

(1) The Technical Regulations Division shall be responsible for setting up and carrying out the necessary procedures for the assessment, notification and subsequent monitoring of notified bodies.

(2) The assessment and monitoring referred to in sub-regulation (1) shall be carried out by the National Accreditation Board (Malta).

(3) The Technical Regulations Division shall inform the Commission of its procedures for the assessment, notification and monitoring of notified bodies, and of any changes to that information.

(4) For the purposes of notification under these regulations, an inspection body shall submit an application for notification to the Technical Regulations Division. The application shall be accompanied by a description of:

(a) the activities relating to conformity assessment, periodic inspection, intermediate inspection, exceptional checks and reassessment of conformity;

(b) the procedures relating to such activities;

(c) the transportable pressure equipment for which the body claims to be competent;

(d) an accreditation certificate issued by the National Accreditation Board (Malta) attesting that the inspection body fulfils the requirements laid down in regulation 15 and the Method for Designating

Conformity Assessment Bodies Regulations, 2003.

(5) The Technical Regulations Division shall notify only those bodies which have satisfied the requirements set out in regulation 15 and the Method for Designating Conformity Assessment Bodies Regulations.

(6) The Technical Regulations Division shall notify to the Commission and the other Member States using the electronic notification tool developed and managed by the Commission. The notification shall include the information required in sub-regulation (4).

(7) The body concerned may perform the activities of a notified body only where no objections are raised by the Commission or the other Member States within two weeks of a notification. Only such a body shall be considered a notified body for the purposes of these regulations.

(8) The Technical Regulations Division shall notify the Commission and the other Member States of any subsequent relevant changes to the notification.

(9) In-house inspection services of the applicant as defined in the Annexes to Directive 2008/68/EC shall not be notified.

(10) Where the Technical Regulations Division has ascertained or has been informed that a notified body no longer meets the requirements laid down in regulation 15 or the Method for Designating Conformity Assessment Bodies Regulations, 2003, or that it is failing to fulfil its obligations, the Technical Regulations Division shall restrict, suspend or withdraw notification as appropriate, depending on the seriousness of the failure to meet those requirements or fulfil those obligations. It shall immediately inform the Commission and the other Member States accordingly.

(11) In the event of withdrawal, restriction or suspension of notification or where the notified body has ceased its activity, the Technical Regulations Division shall take the appropriate steps to ensure that the files of that body are either processed by another notified body or kept available for the responsible notifying and market surveillance authorities on request.

(12) The Technical Regulations Division shall provide the Commission, on request, with all information relating to the basis for the notification or the maintenance of the competence of the body concerned.

(13) Notified bodies notified by the Technical Regulations Division shall be authorised to work in all Member States. The Technical Regulations Division, having carried out the initial assessment and notification, retains the responsibility for monitoring the ongoing activities of the notified body.