United Kingdom Medical Device Regulation

UK regulatory body, the Medicines and Healthcare products Regulatory Agency (MHRA), has issued guidance relating to the regulation of medical devices and in vitro diagnostic medical devices from January 1, 2021.  

To summarize, CE marking will continue to be used and recognized in Great Britain (England, Scotland and Wales) until June 30, 2023.  From July 2023, companies must meet the requirements for placing a new UKCA mark on their device. A new route to market and product marking will be available for manufacturers wishing to place a device on the Great Britain market from January 1, 2021.  In addition, from January 1, all medical devices and in vitro diagnostic medical devices being placed on the UK market need to be registered with the MHRA.  Manufacturers located outside of the UK will also be required to appoint a UK Responsible Person to manage the products in country. 

Further guidance relating to applicable legislation, obtaining product certification, conformity marking and registering devices can be found on the MHRA website. 

As mentioned above, the above regulations will only apply to England, Scotland and Wales.  Different rules will apply for Northern Ireland where the European Union CE mark will still be required and EU regulations adhered to in order to place devices on the market.  Find additional information and further guidance relating to Northern Ireland.  

For more information about the medical device, in vitro diagnostics or broader healthcare market, please contact Cheryl Withers via email at cheryl.withers@trade.gov .