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Post-Brexit: medical device compliance

Ed Ball offers an insight into the post-Brexit implications for medical device compliance.

By 30 June 2023, manufacturers will need to have obtained a UK Conformity Assessment certification (UKCA mark) for all their devices, as CE marks will stop being recognised in Great Britain.

While focusing their efforts towards EU Medical Device regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) compliance, manufacturers may have overlooked another pending regulatory challenge. With Brexit comes a whole new set of regulatory requirements that all manufacturers with products on the UK market will need to implement. By 30 June 2023, manufacturers will need to have obtained a UK Conformity Assessment certification (UKCA mark) for all their devices, as CE marks will stop being recognised in Great Britain (England, Scotland and Wales) after that point.

With the MDR deadline imminent and the IVDR deadline only a year away, continued availability of medical devices to UK healthcare services will depend on manufacturers keeping pace with multiple regulatory tim

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Upcoming Events

Arab Health 2022

Dubai World Trade Centre
24th - 27th January

Central Sterilising Club 60th Anniversary Annual Scientific Meeting

Crowne Plaza, Bridge Foot, Stratford-upon-Avon, CV37 6YR
4th - 5th April

iM Med Decontamination Academy Spring Conference

Royal College of Physicians, London
11th May 2022

Access the latest issue of Clinical Services Journal on your mobile device together with an archive of back issues.

Download the FREE Clinical Services Journal app from your device's App store

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