Medical Devices, Brexit and the UKCA

Medical Devices, Brexit and the UKCA

The UK has officially ceased to be a member of the European Union. We will continue to keep you informed on the new UKCA and future UK regulation of medical devices and in vitro diagnostics.

The UK has officially ceased to be a member of the European Union. We will continue to keep you informed on the new UKCA and future UK regulation of medical devices and in vitro diagnostics.

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Medical Devices, Brexit and the UKCA
Medical Devices, Brexit and the UKCA
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Labeling transition from the UK (0086) to NL (2797) BSI Notified Bodies

Due to the ongoing Brexit trade negotiations and the unpredictable outcomes, there is an increased risk that products, including medical devices and IVDs labeled with a UK notified body number might face challenges in clearance at the EU border customs after 01 January 2021.

This communication is critical for you if you migrated your CE certificates from BSI UK (0086) to BSI NL (2797), and you are currently completing your labeling transitions, and there is any possibility of a delay to your strategy, which means that you may not complete all labeling transitions by December 2020. We understand that COVID-19 may have negatively impacted your preparations, or you are planning to complete your labeling transitions in 2021.

Impact and actions for your products

At the time of certificate migration, the majority of which were completed in early 2019, BSI allowed up to two years for labeling transitions, based on traceability of information between its UK and NL Notified Bodies. This was agreed upon with our regulators and designed to allow you enough time to transition your products labeling.

EU guidance on industrial products, which covers medical devices and IVDs, indicates that manufacturers will have to adapt their product labeling, where necessary, by 1 January 2021. To mitigate the increased risk of your products not being cleared at the EU borders, BSI strongly recommends that manufacturers consider completing their labeling transitions by the end of this year.


Requirement to appoint EU Authorized Representative



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