Module 19: Regulation of In Vitro Diagnostic Medical Devices

18/04/2023

So what about the UK?

The status so far… Post Brexit arrangements required a new approach

Consultation text published 26 th June 2022

Feedback from all stakeholders Response to specific questions Regulation implementation of 1 st July 2023

The Organisation for Professionals in Regulatory Affairs

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UK MDR2002 and UKCA

MHRA Objectives The safety of medical devices The availability of medical devices, and

The likelihood of the UK being seen as a favourable place in which to carry out research relating to medical devices, develop medical devices, and manufacture or supply medical devices. • Support innovation

• International best practise • Stepwise transition process

The Organisation for Professionals in Regulatory Affairs

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