Effective June 16, 2025, the MHRA’s Medical Devices (Post-Market Surveillance Requirements) (Amendment) Regulations 2024 came into effect, reinforcing the Medical Devices Regulations 2002 with a structured, risk-based post-market surveillance (PMS) system.
Applicable to all devices, including reusable devices, in vitro diagnostics (IVDs), and active implants, the regulation requires comprehensive PMS planning, risk-based Periodic Safety Update Reports (PSURs), and Post-Market Surveillance Reports (PMSRs) for the Great Britain market.
The regulation emphasizes the use of real-world evidence, public and patient engagement through feedback, and transparency to enhance device safety and effectiveness. It strengthens FSCAs and requires electronic submissions via the MORE portal.
These changes reflect the UK’s shift toward a proactive, data-driven regulatory framework, requiring prompt industry adaptation to maintain compliance and ensure patient safety.
Key Changes Simplified
| Requirement | Previous Requirement | 2024 Amendment |
|---|---|---|
| Definition of Serious Incident | Focused on actual adverse outcomes | Expanded to include anticipated severe deterioration requiring intervention, including self-administered treatment. |
| PMS Plan | Not mandatory | Mandatory for all devices; must include objectives, methodology, data sources, analysis, CAPA linkage, and patient/public feedback. |
| Self-Administered Treatment | Not explicitly mentioned | Recognized as a valid medical intervention to prevent serious deterioration. |
| Reporting time for Serious deterioration in health | 30 days | Reduced to 15 days. |
| Frequency for PSUR/PMSR | Undefined for many legacy devices. | Set by classification: Class III/IIb – annual PSUR, Class IIa – biennial PSUR, Class I/others PMSR required within 3 years of placement or regulation coming into force, then every 3 years if needed. |
| Availability of PMSR/PSUR to MHRA | Vague or variable timelines | Must be available to MHRA within three working days upon request. |
| Patient and Public Feedback | Encouraged, not explicitly required. | . Mandates patient and public engagement. Manufacturers are obligated to collect and document user feedback on safety, performance, and usability where relevant, particularly for home-use or self-care devices. |
| Trend Reporting | Not explicitly required. | Now mandatory even when individual events are not reportable, to ensure early signal detection. Detailed information to be included within a Trend report. (not required for the custom-made devices) |
| Summary Reporting for Multiple Serious Incidents | Not specified | Manufacturers may submit a summary report instead of individual reports for multiple serious incidents involving the same device model or variant, provided the root cause has been identified, corrective actions have been taken, and the approach has been agreed upon with the MHRA. |
| Unique Device Identification (UDI) in the incident report | Optional or inconsistently used. | The inclusion of UDI is now mandatory. |
| Field Safety Notice (FSN) and FSCA | FSNs are published selectively; no specific dissemination method is required. | All FSCA notifications must be submitted via the Manufacturer Online Reporting Environment (MORE); FSNs must be published on the company website. |
| MORE System Schema Updates | Did not fully reflect the GB-specific regulatory structure. | The new schema includes fields for UK Responsible Person (UKRP) contact details, UK Approved Body (UKAB) ID, Unique Device Identification (UDI), and Global Medical Device Nomenclature (GMDN) codes, enhancing traceability and compliance. |
| Official Reference | ||
Implications for Manufacturers
The revised regulation imposes stricter obligations on medical device manufacturers. They must implement a robust PMS system and plan that covers the entire device lifetime and performance, incorporating real-world data collection and analysis. Manufacturers are required to report serious incidents and trending risks promptly, in line with legally binding timelines, using the MHRA’s MORE system, and publish Field Safety Notices (FSNs) on their websites. High-risk devices require regular PSURs (annually for Class IIb/III, biennially for Class IIa), while low-risk devices (Class I) need PMSRs. Records for PMS must be retained for 15 years for implantable devices and 10 years for other medical devices.
While aligned with the EU Medical Device Regulation (MDR), the UK-specific requirements introduce stricter expectations for traceability, faster incident reporting, public and patient engagement, and clearer corrective action conventions, significantly increasing the regulatory compliance workload for manufacturers.
Strategic Focus for Manufacturers
- Digitize PMS Systems: Automate monitoring, reporting, and compliance for real-time insights.
- Enhance Risk-Based Surveillance: Identify safety issues to protect patients and ensure their well-being.
- Strengthen cross-functional coordination: Align regulatory, safety, quality, clinical, and engineering teams for faster, unified action.
Connect with our experts for tailored support and assistance.
Navigating the ever-changing landscape of UK medical device regulations requires not only expertise but also a strong local presence. ClinChoice’s UK-based safety and regulatory team provides comprehensive support throughout the entire product lifecycle. Whether it’s PMS planning, vigilance reporting, PSUR/PMSR preparation, regulatory submissions, complaint handling, or clinical evaluations, we offer thorough, end-to-end solutions that ensure compliance and help you succeed in the competitive marketplace.
Ensure your device’s success in the UK market—partner with ClinChoice for trusted, expert-driven compliance.