| Theme | Conformity assessment bodies assessment with a view to designation as a notified body |
| Target Audience | Conformity assessment bodies, notified bodies, designating authorities, joint assessment teams |
| Products concerned | MD, IVD |
| Documents mentioned | IMDR (EU) 2017/745 – Article 39 IVDR (EU) 2017/746 – Article 35 |
This document provides guidance :
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- NBs when establishing the Corrective and Preventive Action Plan (CAPA) to address non-conformities (NCs) arising from joint assessments under Article 39(5) of the MDR or Article 35(5) of the IVDR.
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- Designating authorities when examining and giving opinions on the Notified Bodies’ CAPA plans, in accordance with Article 39(7) of the MDR or Article 35(7) of the IVDR
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- joint assessment teams when examining the CAPA plan and the opinion of the designating authority thereon in accordance with Article 39(7) of the MDR or Article 35(7) of the IVDR
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