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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UKCA market access for medical devices

Given the stringent requirements on patient safety and device performance, accessing Great Britain market brings challenges that can delay your product launch. It is critical to work with a UK Approved Body that understands the industry and has the experience to review and confirm your product’s readiness for market.

BSI UK (0086) is a leading Approved Body under the UK MDR 2002, as amended. We review your medical device to ensure conformity against UK legislation by offering a range of flexible product review services providing you with efficient pathways to bring your product to market.




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