S.L. 427.40 Art. 18Operational obligations of notified bodies.

(1) Notified bodies shall carry out conformity assessments in accordance with the conformity assessment procedure provided for in regulation 13.

(2) Conformity assessments shall be carried out in a 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) Where a notified body finds that the requirements set out in regulation 9 and Schedule I or in corresponding harmonised standards have not been met by a manufacturer, it shall require that manufacturer to take appropriate corrective measures and shall not issue the EC-type examination certificate as referred to in regulation 13.

(4) Where, in the course of the monitoring of conformity following the issue of a EC-type examination certificate, a notified body finds that a toy is no longer in compliance, it shall require the manufacturer to take appropriate corrective measures, and shall suspend or withdraw the EC-type examination certificate if necessary.

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

(6) Notified bodies shall inform the Regulatory Affairs Directorate of the following:

(a) any refusal, restriction, suspension or withdrawal of an EC-type examination certificate;

(b) any circumstances affecting the scope of and 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.

(7) Notified bodies shall provide the other bodies notified under these regulations or under Directive 2009/48/EC which carry out similar conformity assessment activities covering the same toys with relevant information on issues relating to negative and, on request, positive conformity assessment results.

(8) Notified bodies shall participate, directly or by means of designated representatives, in the appropriate coordination and cooperation groups for notified bodies organised by the Commission.