Module 14: Design Development and Certification of Medical Devices

17/11/2023

• Before & After Brexit • EU vs UK legislation • Transition period • UK MDR 2002 • Approved Bodies • Conformity Assessment

The Organisation for Professionals in Regulatory Affairs

3

The way it was

• Manufacturer is based outside the EEA

• Manufacturer is based in the EEA

Manufacturer

Authorized Rep

Importer

End User

End User

Manufacturer

The Organisation for Professionals in Regulatory Affairs

4

2