Module 14: Design Development and Certification of Medical Devices

17/11/2023

EU Notified Bodies

NANDO Database • List of Notified Bodies (on EC website)

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The Organisation for Professionals in Regulatory Affairs

15

Managing Essential Requirements

• GSPR Checklist according to MDR is acceptable for both EU and UK • IMDRF and ISO guidances still applicable for both EU and UK

The Organisation for Professionals in Regulatory Affairs

16

8