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S.L. 427.70 · sl/427.70 (S.L. 427.70)

S.L. 427.70 Art. 21Notification procedures. S.L. 427.45 S.L. 427.45 S.L. 427.45

In KraftAmtlicher Text

(1) A conformity assessment body established in Malta shall submit an application for notification under these regulations to the Technical Regulations Division. National Accreditation Board (Malta) attesting that the conformity assessment body fulfils the requirements laid down in regulation 20 and the Method for Designating Conformity Assessment Bodies

Regulations.

(3) The Technical Regulations Division may only notify conformity assessment bodies which have satisfied the requirements laid down in regulation 20 and the Method for

Designating Conformity Assessment Bodies Regulations.

(4) The Technical Regulations Division shall notify conformity assessment bodies to the European Commission and the other Member States using the electronic notification tool developed and managed by the Commission.

(5) The notification shall include full details of the conformity assessment activities, the conformity assessment module or modules, pyrotechnic article or articles concerned and the relevant attestation of competence.

(6) The body concerned may perform the activities of a notified body only where no objections are raised by the European 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.

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

(8) Where the Technical Regulations Division has ascertained or has been informed that a notified body no longer meets the requirements laid down in regulation 20 or the Method for

Designating Conformity Assessment Bodies Regulations 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 European Commission and the other Member States accordingly.

(9) In the event of restriction, suspension or withdrawal of notification, or where the notified body has ceased its activity, the Technical Regulations Division 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.

(10) 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. proportionate manner, avoiding unnecessary burdens for economic operators. Conformity assessment bodies shall perform their activities taking due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the technology of the toy in question and the mass or serial nature of the production process. In so doing, they shall nevertheless respect the degree of rigour and the level of protection required for the compliance of the toy with these regulations.

(3) Notified bodies carrying out conformity assessments shall assign registration numbers, identifying pyrotechnic articles which have been subject to a conformity assessment and their manufacturers, and shall maintain a register with the registration numbers of pyrotechnic articles for which they have issued certificates.

(4) Where a notified body finds that essential safety requirements set out in Schedule I or corresponding harmonised standards or other technical specifications have not been met by a manufacturer, it shall require that manufacturer to take appropriate corrective measures and shall not issue a certificate of conformity.

(5) Where, in the course of the monitoring of conformity following the issue of a certificate, a notified body finds that a pyrotechnic article no longer complies; it shall require the manufacturer to take appropriate corrective measures and shall suspend or withdraw the certificate if necessary.

(6) Where corrective measures are not taken or do not have the required effect, the notified body shall restrict, suspend or withdraw any certificates, as appropriate.

(7) Notified bodies shall inform the Technical Regulations Division of the following:

(a) any refusal, restriction, suspension or withdrawal of a certificate;

(b) any circumstances affecting the scope of or conditions for notification;

(c) any request for information which they have received from market surveillance authorities regarding conformity assessment activities;

(d) on request, conformity assessment activities performed within the scope of their notification and any other activity performed, including cross-border activities and subcontracting.

(8) Notified bodies shall provide the other bodies notified under Directive 2013/29/EU carrying out similar conformity assessment activities covering the same pyrotechnic articles with relevant information on issues relating to negative and, on request, positive conformity assessment results.