Module 14: Design Development and Certification of Medical Devices

17/11/2023

After Brexit

• For the EEA, the UK is now a “third country” and so requires an EU Authorized Rep and Importer • MD’s for the EEA continue to require a CE Mark, obtained from a Notified Body in the EU, that is accredited under the MDR

• And for the UK…

The Organisation for Professionals in Regulatory Affairs

Diverging approaches to MD requirements – EEA and UK

5

The Organisation for Professionals in Regulatory Affairs

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