United Kingdom Medical Devices
The Medicines and Healthcare products Regulatory Agency (MHRA), has published its response to a recent consultation on how medical devices and in vitro diagnostic medical devices will be regulated in the United Kingdom.
During the consultation, which was concluded in November 2021, the MHRA asked for public opinion on proposed changes to the existing regulatory framework. A variety of stakeholders such as patient groups, medical device manufacturers, healthcare professionals, trade bodies and members of the public provided feedback. The MHRA’s response was published on June 26, 2022. It consists of seventeen chapters:
- Scope of the Regulations
- Classification
- Economic Operators
- Registration and UDI
- Approved Bodies
- Conformity Assessments
- Clinical Investigation and Performance Studies
- Post-market Surveillance, Vigilance, Market Surveillance
- In vitro Diagnostic Medical Devices
- Software as a Medical Device
- Implantable Devices
- Other Product Specific
- Environmental Sustainability and Public Health Impacts
- Alternative Routes to Market
- Transitional Arrangements
- Feedback
- Questions for the general public
Since the UK’s departure from the European Union (EU) in January 2020, there have been various changes to the requirements for placing devices on the market with differences for products being sold into Great Britain (England, Scotland, and Wales) and Northern Ireland, which in accordance with the Northern Ireland Protocol still adheres to EU regulations. The proposed changes will currently apply to Great Britain.
Existing and potential U.S. importers will find it helpful to review the document or relevant chapters. For example, Chapter 15 outlines the potential transitional timeline for existing UKCA or CE marked devices. Next steps and the timeline to incorporate the proposals into law via new legislation aren’t currently known. CS UK intends to monitor developments and forward updates or guidance as they arise. A link to the MHRA’s response can be found here.
For information or updates on the healthcare sector please contact: Cheryl Withers, Commercial Specialist Email: Cheryl.Withers@trade.gov orTel: +44 (0)20 7891 3471.