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ViewAttendees 36

Medical Devices

UKCA: challenges and opportunities

Friday, May 12, 2023
12:00 – 13:00 CEST
Location: Pearl 3

Supported By
Description: A new medical device regulation is currently being written for the post-brexit UK. This should become applicable from summer 2024 and although the legislation is not published yet, the general plans and intentions of the UK government have been made public.
The new UK regulation should be aligned to some extent with the EU MDR and might allow partial or full recognition of other countries’ regulatory approvals.

In this session the plans, expected outcomes, potential challenges and opportunities will be discussed from three different perspectives: the regulator’s (MHRA), the UK Approved Body’s (BSI) and the industry’s (ABHI).

Learning Objectives:

  • Upon completion, participants will have an understanding of the current medical devices regulation in the UK and what is expected for the future UK MDR
  • Upon completion, participants will better understand processes, interpretations and expectations of UK Approved Bodies and of MHRA
  • Upon completion, participants will understand how to plan the and achieve UKCA certification, taking advantage of the opportunities the new regime might bring