Module 14: Design Development and Certification of Medical Devices

17/11/2023

What is needed?

• New Medical Devices for the UK will require a UKCA Mark • UKCA Mark issued in relation to the class of medical device, and may be self-certified or require Notified Body approval • Certified against UK MDR 2002 which is based on the original MDD • Transitional arrangements for existing devices • A UK representative is required for non-UK-based manufacturers • Medical Device must be registered with MHRA before being placed on the market.

The Organisation for Professionals in Regulatory Affairs

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Transition period

Brexit start

July 1, 2028 or July 1, 2030 for IVDs

Jan 1, 2021

Only UKCA is authorized

Both CE & UKCA are authorized

EU Notified Body & UK Approved Body

Only UK Approved Body

The Organisation for Professionals in Regulatory Affairs

Diverging approaches to MD requirements – EEA and UK

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