S.L. 427.40 Art. 17Notification procedure. S.L. 427.45 S.L. 427.45 S.L. 427.45

(1) A conformity assessment body established in Malta shall submit an application for notification under these regulations to the Regulatory Affairs Directorate.

(2) The application referred to in the preceding sub-regulation shall be accompanied by a description of the conformity assessment activities, the conformity assessment module or modules and the toy or toys for which that body claims to be competent, as well as by an accreditation certificate, where one exists, issued by the National Accreditation Board (Malta) attesting that the conformity assessment body fulfils the requirements laid down in regulation 16 and the Method for Designating Conformity Assessment Bodies

Regulations.

(3) Where the conformity assessment body concerned cannot provide an accreditation certificate, it shall provide the Regulatory Affairs Directorate with the documentary evidence necessary for the verification, recognition and regular monitoring of its compliance with the requirements laid down in regulation 16.

(4) The Regulatory Affairs Directorate may only notify conformity assessment bodies which have satisfied the requirements laid down in regulation 16 and the Method for Designating Conformity Assessment Bodies Regulations.

(5) The Regulatory Affairs Directorate shall notify conformity assessment bodies to the Commission and the other Member States using the electronic notification tool developed and managed by the Commission.

(6) The notification shall include full details of the conformity assessment activities, the conformity assessment module or modules, toy or toys concerned and the relevant attestation of competence.

(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 Regulatory Affairs Directorate shall notify the Commission and the other Member States of any subsequent relevant changes to the notification.

(9) Where the Regulatory Affairs Directorate has ascertained or has been informed that a notified body no longer meets the requirements laid down in regulation 16 or the Method for

Designating Conformity Assessment Bodies Regulations, or that it is failing to fulfil its obligations, the Regulatory Affairs Directorate 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.

(10) In the event of restriction, suspension or withdrawal of notification, or where the notified body has ceased its activity, the Regulatory Affairs Directorate shall take appropriate steps to ensure that the files of that body are either processed by another notified body or kept available to the responsible notifying and market surveillance authorities, at their request.

(11) The Regulatory Affairs Directorate 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.