From 16 June 2025, any medical device placed on the market in Great Britain must comply with the new UK post-market Surveillance requirements. Published in December 2024, the new Regulations introduce stricter post-market surveillance provisions under the UK regulatory regime.
The new rules apply to medical devices entering the market in England, Scotland, and Wales. On the other hand, they do not apply to devices no longer placed on the market or put into service after 16 June 2025. Northern Ireland continues to follow PMS requirements compliant with the EU regulations.
Requirements of the manufacturers PMS system
Manufacturers must update their documentation and processes of their UKCA-marked devices. The MHRA expects – but does not mandate – that manufacturers of CE-marked devices apply the new PMS provisions to their devices, too.
The manufacturer must define their PMS system within a PMS plan. Compared to the previous Regulations, drafting a PMS plan is now mandatory. The minimum elements of a PMS plan are:
- Objectives of the PMS system
- Processes to gather information (ensuring comprehensive real-world data)
- Data analysis’ methods
- Vigilance reporting obligations
- Preventive and corrective actions as part of a risk management process
Manufacturers must also issue post-market surveillance reports (PMSR) and periodic safety update reports (PSUR), depending on the device’s class:
Source: MHRA 2025
Reporting under the Medical Devices Vigilance System
When manufacturers place medical devices on the UK market, they must submit reports to the MHRA when incidents occur and also take appropriate action to address safety risks when required (known as field safety corrective actions (FSCAs)).
The actors responsible for reporting incidents and FSCAs are the manufacturer and the UK Responsible Person. The MHRA must be notified immediately as soon as the manufacturer becomes aware that their device has caused or might have caused an incident.
Important changes introduced by the UK PMS Regulations
Some of the key differences introduced by the new UK PMS Regulations include:
- Details on what must be included in a PMS system.
- Definition of the post-market surveillance period as well as of other terms such as “serious incident”, “life-time”, among others.
- Improved serious incident reporting obligations.
- Clearer obligations when conducting a Field Safety Corrective Action (FSCA) and detailed requirements relating to Field Safety Notices (FSN).
- Stricter requirements for manufacturers when conducting reviews of their PMS data.
Do you have questions on compliance of medical devices in the UK and how they differ from the EU? Get in touch.
References:
MHRA (2025). Guidance. The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024: guidance on implementation. Retrieved on 01/04/2025.
Simona Varrella
Regulatory Intelligence & Innovation Department
01/04/2025