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 full-scope 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 certification services providing you with efficient pathways to bring your product to market.



UKCA marking guide

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.



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