Module 14: Design Development and Certification of Medical Devices

17/11/2023

EU vs UK legislation

Active Implantable Medical Device Directive 90/385/EEC

Active Implantable Medical Device Directive 90/385/EEC

Medical Device Regulation 2017/745

UK MDR 2002

In-Vitro Medical Device

In-Vitro Medical Device

Directive 98/79/EC

Directive 98/79/EC

In Vitro Medical Device

UK Medicines & Medical Devices Act 2021

Regulation 2017/746

Medical Device Directive 93/42/EC

Medical Device Directive 93/42/EC

The Organisation for Professionals in Regulatory Affairs

Diverging approaches to MD requirements – EEA and UK

7

UK Legislation

UK MDR 2002 • Based on

•

Introductory Provision for all MD

I.

• 93/42/EC • 98/79/EC • 90/385/EC

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

• UK MDR 2023

• Extended transitional

arrangements in relation to CE Mark acceptance • EU MDR 2017/745 and IVDR 2017/746 are revoked • UK Medicine and Medical Devices Act 2021

The Organisation for Professionals in Regulatory Affairs

Diverging approaches to MD requirements – EEA and UK

8

4