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The impact of Brexit on medical device regulation

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By John Connolly | October 23, 2020

Starting January 1, transition arrangements for device companies begin.

As a consequence of Britain leaving the EU, the U.K. laws regulating medical devices and in vitro diagnostic medical devices (IVDs) are changing.

Effective January 1, 2021, the Medicines and Healthcare products Regulatory Authority (MHRA) will become responsible for all medical devices sold in the U.K. that are currently undertaken through the EU systems.

All medical devices will require registration with the MHRA within defined grace periods. MHRA will continue to recognize existing CE marking and EU certificates until June 30, 2023.

After this date, devices will require a U.K. Conformity Assessed (UKCA) mark, which the EU won’t recognize, so a CE mark will still be required for EU markets.

Addtionally, devices sold in Northern Ireland will require both UKCA and CE marks.

Manufacturers based outside of the U.K. selling medical devices in the U.K. are required to appoint a U.K. Person Responsible (UKPR).

Find details of the changes at UK.gov

If you would like to know more about how this might affect your insurance arrangements, please contact me.

Disclaimer

Willis Towers Watson hopes you found the general information provided in this publication informative and helpful. The information contained herein is not intended to constitute legal or other professional advice and should not be relied upon in lieu of consultation with your own legal advisors. In the event you would like more information regarding your insurance coverage, please do not hesitate to reach out to us. In North America, Willis Towers Watson offers insurance products through licensed subsidiaries of Willis North America Inc., including Willis Towers Watson Northeast Inc. (in the United States) and Willis Canada, Inc.

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Life Sciences Industry Leader – North America

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