UKCA marking | Gain market access in United Kingdom with UKCA marking approval

Accessing the European and UK markets bring challenges that can lead to delays in your product launch. Such delays can be costly for the manufacturer, and for patients who require care. However, there are stringent requirements in place to ensure patient and user safety, as well as the performance of the device.

BSI The Netherlands B.V (2797) is a leading European Notified Body; we assess medical devices to ensure that they conform to the requirements of the European Directives and Regulations. BSI UK Assurance Ltd (0086) is a UK Approved Body able to provide conformity assessments under the new UKCA scheme for the Great Britain 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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