UKCA marking

UKCA marking

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Medical Devices and the UKCA
Medical Devices 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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UKCA certification process

Download our UKCA marking with BSI guide it will take you through our certification process starting from your application to BSI, to UKCA Certificate issuing to your company.

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UKCA for medical devices and IVDs

Download our UKCA marking frequently asked questions guide* to learn more about taking medical devices and IVDs to market in Great Britain.


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Clinical Masterclass Series

Our webinar series is back!

Join us for part 2 of our Clinical Masterclass Series in 2023 and listen to our experts discuss various aspects of the MDR. From preparing a Clinical Evaluation Plan, to supporting you with preparing a Clinical Evaluation Report, advice on PMCF and SSCP and much more.





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