Understand the new MHRA post-market surveillance requirements for UK medical devices.
From 16th June 2025, new MHRA PMS requirements are now applicable to all CE and UKCA-marked medical devices placed on the Great Britain (GB) market. These changes, introduced under the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (SI 2024 No. 1368), amend the UK Medical Devices Regulations 2002. The new PMS rules aim to improve device monitoring, strengthen patient safety, and align GB expectations more closely with international standards.
What are the new MHRA PMS requirements in 2025?
Mandatory PMS plans
Manufacturers are required to produce a written PMS plan (PMSP) that sufficiently reviews the safety and performance data for the lifetime of the device. The plan shall outline the following:
The new regulations outline specific requirements of manufacturers to collect user experience data and outline statistical methodologies to assess and identify trends.
What reports do manufacturers need to submit under MHRA PMS?
Manufacturers of low-risk medical devices (Class I) and (Class A, (A(s), B, and General IVDs) must produce a post-market surveillance report (PMSR). Reports must contain a review of the data outlined in the PMSP and must be updated every three years, which differs from EU MDR requirements of when it is deemed necessary.
A Periodic Safety Update Report (PSUR) must be produced for higher-risk devices (Class IIa, IIb and III) and higher-risk IVDs (Class C, D and listed in Annex II). The PSUR contains a more detailed review of the device, including the size and characteristics of the population using the device, both inside and outside the UK.
Reporting frequency is determined by risk classification. Class IIa are required to update their reports every 2 years, while Class III, IIb, active implantable medical devices and Annex II List A and B IVDs are required to update annually.
The PMSR/ PSUR must be made available within 3 working days upon request by the Medicines and Healthcare products Regulatory Agency (MHRA).
Note: To avoid duplication, manufacturers may leverage reports already in place for the EU, ensuring they specifically address GB requirements within the report.
How have MHRA vigilance requirements changed in 2025?
The UK requirements for incident reporting have become more stringent. Manufacturers must now report a serious incident within 15 working days of being made aware of the incident, comparable to the previous requirement of 30 days. Incident reporting is achieved through the new digital platform Manufacturer’s Online Reporting Environment (MORE).
Additionally, there is a broadened scope of incidents. Manufacturers must now consider situations where the device malfunctions or deteriorates in characteristics or performance, irrespective of the potential to lead to direct patient harm.
All incidents must be appropriately assessed to determine if it meets the requirements of a serious incident and must be reported to the MHRA. This assessment must be appropriately documented, within the PMSR/PSUR and as trend reports (described below).
A new requirement also outlines the need for the manufacturer to notify the MHRA if an FSCA is being conducted outside of Great Britain, if the same device is supplied on the GB market.
What does MHRA expect from trend reporting in 2025?
Manufacturers should submit trend reports for both incidents that are reportable individually, as well as those which do not meet the criteria for individual reporting. Akin to the reporting of incidents, the UDI should also be included in the trend reports.
What are the implications of the 2025 PMS changes?
What are the implications for you as a manufacturer?
The changes are now mandatory and will significantly impact manufacturers with devices placed on the UK market as they will need to re-evaluate their PMS systems and associated processes currently in place.
What are the consequences of non-compliance?
Failure to comply by the implementation date, 16th June, may result in the following immediate MHRA enforcement actions:
Non-compliance may interrupt operations, restrict market access, and damage reputation.
When does the MHRA PMS regulation come into effect?
The regulations are in effect as of 16th of June 2025.
I already have a PMS system in place for the EU – do I need to create a new system for the UK?
No, the EU PMS system in place can be leveraged to achieve dual compliance but you must ensure that specific GB requirements are clearly outlined in your documentation.
The following table highlights the core differences between UK and EU PMS systems.
| Requirement | EU | UK MDR 2002 |
| Post Market Surveillance System | MDR and IVDR requirement for PMS system in the QMS | No explicit requirement |
| Post-market Surveillance plan | No specified requirements of statistical methodologies for detecting trends or information about user experience No reference to devices outside EU market | Specified statistical methodologies for detecting trends information about user experience References comparison with devices outside of UK market |
| Reporting of serious incidents | MDR and IVDR state EUDAMED for reporting. | MHRA utilise Manufacturer’s Online Reporting Environment (MORE) |
| Reporting of Field Safety Corrective Actions (FSCAs) | FSCAs are submitted via EUDAMED FSCAs are coordinated across EU member states, with input for the European Commission | FSCAs are reported to the Secretary of State, with no electronic system FSCAs are limited to UK oversight |
| Reports received by the UK Secretary of State | N/A | Manufacturer requirement to consider if user reports are ‘reportable’ and may require action |
| Post-market surveillance report | Periodic updates required when deemed necessary by the manufacturer | Fixed periodic updates every 3 years Pre-market actions linked to certification or conformity |
| Periodic safety update report (PSUR) | No specified requirements for devices sold and used internationally | Requirements for devices sold and used internationally Including size of population using device in UK and outside UK |
| Trend reporting | Electronic reporting system Emphasises coordination across the EU | Specific requirements for GB trend reporting. Detailed initial and final reports submitted to the Secretary of State with stricter follow-up timelines |
What should manufacturers do to stay compliant with MHRA PMS?
Manufacturers must ensure the new requirements are fully understood to ensure they plan and establish a compliant PMS system. Conducting a GAP analysis on the current PMS system is the first step to help you identify any deficiencies that need to be addressed. It is also recommended to complete company training to ensure that employees are aware of the specific legislative changes.
Conclusion
With the new PMS rules in effect, there is a need to act immediately. Manufacturers are encouraged to review all MHRA guidance documents, alongside the legislation to understand the new requirements.
How can LFH Help?
- Post Market Surveillance Plans
- Post Market Surveillance Reports
- Guidance of Vigilance reporting
- Periodic Safety Update Reports
- Post Market Clinical Follow Ups
- Gap Analysis of Post Market Surveillance
- Ongoing Consultancy Support
- Regulatory Intelligence
We can make regulations easy for you.
If you’d like more information, please feel free to contact us by email at info@LFHregulatory.co.uk or phone on +44 (0)1484662575.
