The UK has released a draft of its proposed Post Market Surveillance Requirements for Medical Devices. If the draft regulations, “The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2023,” are approved, they will pertain to devices sold in England, Wales, Scotland and Northern Ireland, beginning in 2024.
The draft regulations serve as an amendment to the existing UK MDR regulation and focus on Part 4A of UK MDR, post market surveillance (PMS) requirements. They include significantly more detail on the requirements for:
- Development of a PMS System for each device placed on the market, which must be proportionate to the risk posed by the device and appropriate to the type of the device. The PMS system would need to include analysis of data relevant to the quality, performance and safety of the device throughout its lifespan.
- Development of a PMS Plan specifying the process for collection and assessment of information on serious incidents and side effects, field safety corrective actions, how incident trends will be identified and reported, management of feedback and complaints, and information on user experience with the device; processes to investigate complaints and manage incidents and trends, and a process for communicating with the Secretary of State, UK Responsible Person (UKRP), and users and suppliers of the device.
- Development of Preventive and Corrective Actions that include notification and monitoring to identify the need for further action to reduce the risks posed and bring the device into conformity.
- Development of a PMS Report (PMSR), which must be produced within three years of the device being placed on the market or put into service, and updated every three years.
In addition, the draft regulations detail the process of initial reporting, investigation and final reporting of serious incidents. The draft regulations were presented to the World Trade Organisation (WTO) and are currently open to comments from WTO members.