What are the new Post-Market Surveillance requirements in the uk from june 2025?
Starting 16 June 2025, new post-market surveillance (PMS) obligations will apply to all medical devices placed on the market in Great Britain. These changes affect in vitro diagnostic (IVD) devices, implantables, and all classes of general medical devices.
Manufacturers, authorised representatives, and other economic operators must be ready to meet these new requirements.
What are the main changes introduced by the new uk PMS rules?
The Medical Devices (Post-Market Surveillance Requirements) (Amendment) Regulations 2024 introduce a new Part 4A into the UK MDR 2002.
Here are the key updates:
- Mandatory PMS requirements for all devices placed on the market in Great Britain, including IVDs and implantables
- Clear terminology: new definitions such as “device lifetime” and “PMS period,” with the recommendation to continue monitoring beyond the validated lifetime
- Risk-based PMS plans: manufacturers must document objectives, data sources (including public and patient feedback), and update frequency
- Periodic reports:
- low-risk devices: PMSR at least every 3 years
- higher-risk devices (class IIb, III, and IVD class C/D): annual PSUR, submitted to the UK Approved Body (UKAB)
- Incident reporting:
- shortened deadline of 15 days (previously 30) for serious incidents or risks
- mandatory inclusion of the UDI
- detailed tracking of investigations and corrective actions
- Access to PMS documents: the MHRA may request PMSR or PSUR at any time, and manufacturers must respond within 3 working days
- Updated templates available: new PMS and incident reporting forms must be used starting 16 May 2025. These templates reflect the updated requirements and ensure that submitted documentation meets MHRA standards.
What is a PMS plan and who needs it?
Every manufacturer placing a device on the GB market from 16 June onwards must prepare a written PMS plan appropriate to the device’s risk class. The plan must be regularly reviewed and available to the MHRA if requested.
The PMS plan helps demonstrate proactive monitoring of device safety and performance throughout its lifecycle.
How should PMS reports be handled?
PMS reports are essential for documenting the effectiveness of your surveillance strategy. They must identify trends, assess risks, and include actions taken to protect patients and users.
- PMSR (Post-Market Surveillance Report) is required for low-risk devices
- PSUR (Periodic Safety Update Report) is required for medium to high-risk devices and must be submitted to the UKAB
These reports are key to maintaining access to the GB market.
What are the new incident reporting rules?
Reporting timelines are now stricter. Serious incidents or potential risks must be reported to the MHRA within 15 calendar days.
The report must include:
- The UDI of the affected device
- The nature of the incident or risk
- Investigation results and any actions taken
Updated reporting forms must be used from 16 May 2025.
How fast must you respond to MHRA requests?
If the MHRA asks for a PMSR or PSUR, the manufacturer must provide it within 3 working days.
Being unprepared may lead to enforcement actions or delays in market access.
How can you prepare before 16 june 2025?
Here are five steps to help you comply:
- Review and update your PMS procedures
- Create risk-based PMS plans for each device
- Train your teams on new reporting rules
- Ensure alignment with your UKRP and UKAB
- Test your internal systems to deliver documentation quickly
Summary of key obligations
- New PMS rules apply in GB from 16 June 2025
- PMS plans are mandatory and must be adapted to risk
- PMSR and PSUR reporting is required at defined intervals
- Serious incidents must be reported within 15 days
- PMS documents must be available to the MHRA within 3 working days
Need help navigating the new UK PMS obligations?
We support manufacturers with tailored compliance strategies. Contact us to discuss how we can help you stay compliant.
Source: For full guidance on the updated post-market surveillance requirements in the UK, visit the official MHRA page: MHRA – Guidance on implementation of the 2024 PMS amendment.
