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 timelines. To provide a starting point and help businesses familiarise themselves with the known UKCA conformity requirements, this article identifies priority areas for attention and areas where new information may still be emerging.
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