Regulation (EU) 2016/424 of the European Parliament and of the CouncilShow full title

Article 34 Operational obligations of notified bodies

1. Notified bodies shall carry out conformity assessments in accordance with the conformity assessment procedures provided for in Annexes III to VII.

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 subsystem or safety component technology 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 subsystem or the safety component with this Regulation.

3. Where a notified body finds that the essential requirements set out in Annex II 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 or approval decision.

4. Where, in the course of the monitoring of conformity following the issue of a certificate or approval decision, a notified body finds that a subsystem or a safety component no longer complies, it shall require the manufacturer to take appropriate corrective measures and shall suspend or withdraw the certificate or the approval decision 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 certificates or approval decisions, as appropriate.