The UK’s PMS overhaul signifies a cultural and operational shift in how medical device safety is approached post-market. On June 16, 2025, the Medicines and Healthcare products Regulatory Agency (MHRA) officially implemented a landmark reform of medical device regulation in Great Britain. This update represents a transformative shift in how manufacturers monitor the safety and performance of medical devices and in vitro diagnostic (IVD) products once they enter the market.
Why This Reform Matters?
With rapid healthcare innovation and technology advancement regulation must evolve to ensure patient safety. The new Post-Market Surveillance (PMS) regulations impose stricter monitoring of real-world device performance, enabling earlier identification of potential safety risks and faster response times to adverse incidents.
Key Changes for Manufacturers
The new PMS framework applies to all UKCA- and CE-marked devices placed on the market in Great Britain after June 16, 2025. Manufacturers should take note of the following:
MHRA’s Vision: Balancing Innovation & Patient Protection
MHRA’s Chief Executive, Lawrence Tallon, emphasized that as medical technology advances, regulatory frameworks must adapt to ensure continuous patient safety. This reform builds a modern, responsive system, reinforcing safety standards while fostering innovation across UK life sciences.
ABHI Guidance on UK's new Post-Market Surveillance (PMS) regulations
The Association of British HealthTech Industries (ABHI) has been actively supporting its members in preparing for the UK's new Post-Market Surveillance (PMS) regulations.
In response to the MHRA’s updated guidance, ABHI hosted dedicated web-meets in 2025 to help manufacturers navigate the new requirements.
Guidance provided and topic discussed by ABHI on PMS includes:
New MIR Form: A GB-Specific Approach
Starting from the enforcement date, all serious incidents occurring in Great Britain must be reported using a GB-specific Manufacturer’s Incident Report (MIR) form. While technically aligning with the EU’s MIR v7.2.1, the GB form introduces essential national adaptations which includes:
These changes aim to align incident reporting with UK regulatory infrastructure and market-specific oversight.
Transition Period & Timeline guidance
In order to support a smooth shift, the EU MIR v7.2.1 form—with GB-specific data—remains temporarily acceptable until 16 October 2025. After that, only the GB-customized MIR will be accepted by the MHRA.
MORE Portal Updates
The MHRA has updated its MORE portal to handle the new MIR structure. This includes:
Northern Ireland Exception
Incidents occurring in Northern Ireland will continue to follow EU regulations, including the transition to MIR v7.3.1 per the European Commission's timeline. The MHRA may consider a future GB-specific 7.3.1 form.
This initiative highlights ABHI’s commitment to guiding the UK medtech sector through regulatory changes while upholding patient safety and fostering innovation.
Implications & Next Steps
This regulatory shift is not just an administrative update—it signals the UK’s commitment to global best practices in medical device regulation. Manufacturers must now align PMS strategies with these UK-specific compliance requirements to maintain market access.
Final Thoughts
The implementation of the UK’s Post-Market Surveillance (PMS) regulations marks a significant evolution in medical device oversight, reinforcing patient safety and ensuring that manufacturers take a proactive approach to monitoring device performance. By establishing stricter reporting timelines, expanded incident tracking, and mandatory trend analysis, the MHRA is building a modern and responsive regulatory system that adapts to emerging risks while supporting innovation in medical technology.
For medical device companies, these regulations demand heightened vigilance and stronger PMS systems to maintain compliance and market access in Great Britain. Looking ahead, this framework will serve as the foundation for future regulatory advancements, including potential international recognition routes, further integrating the UK into global best practices.
Industry stakeholders must remain engaged, provide feedback, and align their PMS strategies with these new requirements to foster a safer and more effective medical device ecosystem for patients and healthcare providers alike.
For further guidance visit : First major overhaul of medical device regulation comes into force across Great Britain - GOV.UK
Adapting to new regulations can be challenging. How is your organization handling it? We welcome your input.
FAQ
What are the main changes in the UK post-market surveillance regulations?
The main changes include more stringent data collection and reporting requirements, an emphasis on continuous risk management, and improved transparency in monitoring the safety and efficacy of medical devices.
How will these changes affect manufacturers of medical devices?
Manufacturers will need to adopt more rigorous monitoring protocols, actively gather real-world data, and report any adverse events or product performance issues in a timely manner.
Why is there an increased emphasis on transparency in post-market surveillance?
Increased transparency is essential for building public trust in medical devices, ensuring that stakeholders, including healthcare professionals and patients, have access to information about device safety and efficacy.
What implications do these new regulations have for public health?
The implications for public health include enhanced safety of medical devices through ongoing monitoring, increased accountability of manufacturers, and improved consumer confidence in the medical device market.
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