Post-Market Surveillance Amendments for Medical Devices

Navigating the 2024 UK Post-Market Surveillance Amendments for Medical Devices

In a significant step toward strengthening patient safety and aligning with global best practices, the UK government introduced the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (S.I. 2024/1368).

These regulations, which amend the UK Medical Devices Regulations ,2002, came into force on 16 June 2025 and are applicable to devices on the British market:

• Part II – general medical devices
• Part III – in vitro diagnostics
• Part IV – active implantable medical devices

Note: Requirements for custom-made medical devices may vary, and may not be applicable to those used in clinical investigation, that have an exceptional use authorisation, or are made in house.

Note: Medical devices placed on the market in Northern Ireland must continue to follow the post-market surveillance rules set out in the EU MRD/IVDR.

This blog provides a breakdown of the new requirements, how they compare with the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), and what pharmaceutical and medical device professionals need to do to ensure compliance.

Key Objectives of the 2024 Post-Market Surveillance Amendments

The primary goals of the 2024 post-market surveillance amendments are to:

• Enhance post-market surveillance obligations for manufacturers.
• Improve traceability and vigilance of medical devices.
• Align UK regulations more closely with international standards, particularly the EU MDR/IVDR, while maintaining regulatory autonomy.

Breakdown of Main Requirements

1. Post-Market Surveillance System

Manufacturers must establish, implement, and maintain a post-market surveillance system that is proportionate to the risk class of the device. This system must:

• Collect and analyse data on device performance and safety.
• Identify any need for corrective or preventive actions.
• Be integrated into the manufacturer’s quality management system (QMS).

2. Post-market surveillance Plan and Report

• Post-Market Surveillance Plan: Required for all devices, detailing the methods and procedures for data collection, analysis, and reporting.
• Post-Market Surveillance Report: For Class I devices, a summary report must be updated as necessary and made available to the MHRA upon request.
• Periodic Safety Update Report (PSUR): Required for Class IIa, IIb, and III devices, and Class C and D IVDs. Must be updated:
  • Annually for Class III and Class D devices.
  • Every two years for Class IIb and Class C devices.
  • As needed for Class IIa devices.

3. Trend Reporting

Manufacturers must report any statistically significant increase in the frequency or severity of incidents or expected undesirable side effects that could impact the benefit-risk determination.

4. Corrective and Preventive Actions (CAPA)

The QMS must permit feedback from the post-market surveillance system to address identified issues. It must be capable of triggering CAPA processes, including:

• Field safety corrective actions (FSCAs).
• Updates to labelling or instructions for use.
• Design or manufacturing changes.

5. Record Keeping and Accessibility

All post-market surveillance documentation must be retained for at least 10 years (15 years for implantable devices) and be readily accessible to the MHRA.

Convergence and Divergence with EU MDR/IVDR

Convergence

• Structure and Terminology: The UK post-market surveillance framework mirrors the EU MDR/IVDR in requiring post-market surveillance plans, PSURs, and trend reporting.
• Risk-Based Approach: Both systems scale requirements based on device classification.
• Integration with QMS: post-market surveillance is embedded within the broader quality system in both jurisdictions.

Divergence

Aspect	UK post-market surveillance (2024)	EU MDR/IVDR
Regulatory Authority	MHRA	National Competent Authorities + EUDAMED
EUDAMED Integration	Not applicable	Mandatory for data submission
Implementation Timeline	6 months post-enactment (June 2025)	Phased from May 2021 (MDR) and May 2022 (IVDR)
Geographic Scope	Great Britain only (England, Scotland, Wales)	EU/EEA
Device Registration	UKCA marking required	CE marking required

Implementation Timeline

Date	Milestone
16 Dec 2024	Regulation enacted
16 Jun 2025	Regulation comes into force
From Jun 2025	Manufacturers must comply with post-market surveillance requirements
Ongoing	PSURs and post-market surveillance reports submitted per device class
Until 30 June 2030	Existing CE marking will be accepted

Practical Steps for Compliance

1. Review and Update Post-Market Surveillance Plans: Ensure they meet the new UK-specific requirements.
2. Classify Devices Accurately: Confirm device classification under UK rules.
3. Develop PSUR Templates: Align with MHRA expectations.
4. Train Regulatory and QA Teams: Ensure understanding of new obligations.
5. Audit QMS: Integrate post-market surveillance processes and documentation.
6. Engage with MHRA: Prepare for potential inspections or data requests.

Strategic Considerations for Pharma Companies

• Dual Market Strategy: For companies operating in both the UK and EU, harmonising post-market surveillance processes can reduce duplication.
• Regulatory Intelligence: Stay updated on MHRA guidance and future amendments.
• Digital Tools: Consider implementing software solutions for post-market surveillance data collection and analysis.

Conclusion

The 2024 post-market surveillance amendments mark a significant evolution in the UK’s medical device regulatory landscape. While they align closely with EU standards, they also reflect the UK’s independent post-Brexit regulatory trajectory. For pharmaceutical and medical device companies, proactive adaptation is essential—not just for compliance, but for maintaining market access and ensuring patient safety.

The MHRA has provided a raft of useful documents that will help professionals navigate this change to their regulations. Find them on the MHRA website.

For a rundown of medical device vigilance in Australia, read Enhancing Medical Device Vigilance in Australia: A Guide for Regulatory Compliance and Patient Safety.

How PharmOut can Help

PharmOut offers online GMP eLearning which can help augment your understanding of the medical device regulatory field. Please go to our sister website to review the available catalogue: Online GMP Training.

FAQs About the UK Post-Market Surveillance Amendment