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 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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