S.L. 427.60 Art. 16Requirements for notified bodies.

(1) Notified Bodies shall comply with the requirements laid down in Schedule III.

(2) Where a notified body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meets the requirements set out in Schedule III and shall inform the Technical Regulations Division accordingly.

(3) Notified bodies shall take full responsibility for the tasks performed by subcontractors or subsidiaries wherever these are established.

(4) Activities may be subcontracted or carried out by a subsidiary only with the agreement of the client.

(5) Notified bodies shall keep at the disposal of the Technical Regulations Division the relevant documents concerning the assessment of the qualifications of the subcontractor or the subsidiary and the work carried out by such subcontractor or subsidiary under these regulations.

(6) Notified bodies shall carry out conformity assessments or have them carried out in accordance with the procedures provided for in regulation 13.

(7) Where a notified body finds that the obligations laid down in regulation 10 have not been met by a manufacturer, it shall require that manufacturer to take appropriate corrective measures without delay and shall not issue a conformity certificate.

(8) Where, in the course of monitoring conformity following the issue of a conformity certificate, a notified body finds that a product no longer complies, it shall require the manufacturer to take appropriate corrective measures without delay and shall suspend or withdraw the certificate if necessary. Where corrective measures are not taken or do not have the required effect, the notified body shall restrict, suspend or withdraw the certificate, as appropriate.

(b) any circumstances affecting the scope of, and the 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.

(10) Notified bodies shall provide the European Commission and the Member States, on request, with relevant information concerning issues relating to negative and positive conformity assessment results. Notified bodies shall provide the other notified bodies carrying out conformity assessment activities covering the same products with information concerning negative and, on request, positive conformity assessment results.

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