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Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (Text with EEA relevance)

article  32

CELEX:  32016R0425

Operational obligations of notified bodies
1. Notified bodies shall carry out conformity assessments in accordance with the conformity assessment procedures provided for in Annexes V, VII and VIII.
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 PPE 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 PPE with the requirements of this Regulation.
3. Where a notified body finds that the essential health and safety requirements set out in Annex II or the corresponding harmonised standards or other technical specifications have not been met by a manufacturer, it shall require the manufacturer to take appropriate corrective measures and shall not issue a certificate or approval decision.
Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (Text with EEA relevance)

article  32

CELEX:  32016R0425

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 PPE 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.