The new Regulations discussed in our previous article UK Medical Device PMS Changes Post-Brexit, will come into effect from 16 June 2025. The Medicines and Healthcare products Regulatory Agency ("MHRA") has published comprehensive guidance to help medical device manufacturers navigate the new Post-Market Surveillance ("PMS") Regulations. Manufacturers must meet all applicable requirements for medical devices placed in the UK market
Establishing Effective PMS Systems
Manufacturers must implement and maintain a PMS system based on a PMS plan for each device. This system should be proportionate to the device's risk, appropriate to its type and include data analysis. The PMS system should be used throughout the device's lifetime and beyond, if necessary.
A device's lifetime extends from its manufacture or production date to the end of the validated period of intended performance, including shelf life. However, as devices may remain in use beyond their lifetime, manufacturers are encouraged to collect PMS data beyond this period.
The PMS system must be outlined in a PMS plan, which should include:
- Objectives of the PMS system
- Processes to gather comprehensive real-world data
- Methods of data analysis
- Fulfilment of vigilance reporting obligations
- Links to preventive and corrective actions as part of a risk management process
Manufacturers must gather and analyse data from a range of sources related to the device performance, incidents, complaints and feedback from both patients and the public. Manufacturers should ensure data collected includes safety information on similar devices which will provide an insight into the impact of their devices across all markets and the impact of competitors devices on their own.
Implementing Preventive and Corrective Actions
A key goal of the PMS process is identifying and implementing preventive and corrective actions to ensure device safety. Manufacturers are required to undertake timely preventive and corrective action whenever necessary to protect the safety of those affected by the use of their medical devices. Preventative actions will reduce risks which may arise through use of the device and will address the causes of non-conformities with the essential requirements. Corrective actions will mitigate safety or conformity issues among already manufactured devices. Field safety corrective actions ("FSCA") must be adopted to address the risk of a serious incident affecting devices outside the manufacturer’s control. If the devices have been made available for use and there is a risk of death or serious deterioration in health, any action taken to reduce or mitigate this risk for the devices will constitute as a FSCA. Manufacturers should communicate all FSCAs to affected customers using a Field Safety Notice, regardless of the medical device type.
Reporting Protocols
Manufacturers must submit different types of reports based on device risk classification:
- Post-market Surveillance Reports for lower-risk devices
- Periodic Safety Update Reports for higher-risk devices
Serious incidents must be reported to the MHRA under the vigilance system, and trend reports must be submitted when significant increases in incident numbers or severity are identified.
Manufacturers are also required to report serious incidents to the MHRA under the vigilance system. The guidance provides clarification on circumstances included under medical incidents and confirms that a serious incident is one which directly, or indirectly, leads to, or could have led under different circumstances to the death of anyone, or serious deterioration in state of health for anyone. The guidance provides further information on the circumstances covered by serious deterioration in state of health, and explicitly states that it includes self-administered treatment which may be required.
Manufacturers must also submit trend reports to the MHRA when identifying significant increases in incident numbers or severity, compared to expected thresholds. These trends could adversely impact required risk analysis.
Prepared for June 2025?
The PMS Regulations bring significant changes that demand thorough preparation from medical device manufacturers. MFMac's Healthcare and Life Sciences team can assist with any queries you may have on the new Regulations and how your organisation can ensure compliance.
This article was written by Erin Thomson, Trainee Solicitor, in MFMac's Healthcare & Life Sciences team.
