Essentials of European Medical Device Regulatory Affairs - June 2020

Notified Body (NB)

• NB may sub contract but retains responsibility • Involvement increases with higher classification of a product • NB numberappears on labelling • Competentauthorities regularly audit NBs andmonitor their assessments of manufacturers

• A NB can cease working (through choice/take over/ CA suspends them) • Certificates are valid for 9 monthsduring any switch

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Notified body oversight (NBO)

• MDR formalises the need for a NB coordination group to meet at least annually • To improve the overall performance of NBs • Provide examples of best practice • Training function • Aim for consistency • Used by NBs and CA • Review TEAM-NB’s NB-MED documents

TheOrganisation for Professionals in Regulatory Affairs

TheOrganisation for Professionals in Regulatory Affairs

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