Module 14 2022

22/03/2022

UK Legislation

LINK

UK MDR 2002 • Based on

Introductory Provision for all MD

I.

•

II. General Medical Devices III. Active Implantable MD IV. IVD V. Approved bodies VI. Fees VII. Miscelaneous

• 93/42/EC • 98/79/EC • 90/385/EC • New regulation (Consultation in November) • EU MDR 2017/745 and IVDR 2017/746 are revoked

The Organisation for Professionals in Regulatory Affairs

Diverging approaches to MD requirements – EEA and UK

9

UK Approved Bodies

Medical Device Active Implantable Medical Devices In-Vitro Diagnostic

Medical Device In-Vitro Diagnostic

In-Vitro Diagnostic

Link

The Organisation for Professionals in Regulatory Affairs

Diverging approaches to MD requirements – EEA and UK

10

5