UK reglementation National Health Services (NHS) (Brexit)

As a result of Brexit, there is a new UKCA marking for medical devices:  Discussion paper on the application of the UKCA marking on medical devices identified with GS1 standards. 

The new regulations will come into effect by July 2023 at the latest and CE marking recognition in the UK will end.

On 21 October 2022,  the Medicines & Healthcare products Regulatory Agency announced an extension of standstill period to avoid disruption to supplies, support innovation and enable safe access to Medical Devices for UK patients. 
They will put in place a twelve-month extension to the current standstill period, aiming to bring the new regulations into force in July 2024.

Please find here attached the official announcement. 


EU Medical Device Regulation (MDR) & in-vitro diagnostics (IVDR)


US regulation Food and Drug Administration (FDA)


Other regulations