United Kingdom Medical Devices Regulatory Environment Update

The UK Department of Health and Social Care executive agency (the Medicines and Healthcare products Regulatory Agency - MHRA), has extended its timeline to implement changes to the current medical device regulatory framework.  Under new plans, “core aspects” of the new regime will apply from July 1, 2025.  Legislation has also been passed extending the acceptance of CE marked medical devices within Great Britain (England, Wales, and Scotland) beyond the original date of June 30, 2023.  Additional information, including timelines as they relate to specific types of devices, can be found here: Implementation of the Future Regulations

Since the UK’s departure from the European Union (EU) in January 2020, there have been different conformity requirements for products being placed on the market in Great Britain and Northern Ireland, which still adheres to aspects of EU law.  Rules for Great Britain include a new route to market and product marking in the form of a UK Conformity Assessed (UKCA) mark.  The CE mark is still required for the Northern Ireland market.  Guidance on how to place medical devices in Great Britain, Northern Ireland, and EU markets can be found here: Regulating medical devices in the UK

 
Additional information about the proposed new regulatory framework can be found in the MHRA’s response to a public consultation, published in June 2022: Consultation on the future regulation of medical devices in the United Kingdom 

CS UK will continue to monitor developments and forward updates or guidance as they arise.  

For information or updates on the healthcare sector, please contact Cheryl Withers, Commercial Specialist.