The MHRA has released a suite of guidance on the new post-market surveillance (PMS) requirements for medical devices in Great Britain, ahead of the regime coming into force on 16 June 2025. 

The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 amend the UK Medical Devices Regulations (MDR) 2002 by inserting a new Part 4A on PMS requirements for medical devices. 

For more information on the Regulations and how they differ from the EU regime, please refer to our article: New Post-Market Surveillance SI published to align UK with EU, subject to key differences for medical device manufacturers

The latest suite of guidance is categorised into four main areas: guidance on implementation of the Regulations; supplementary guidance on a manufacturer’s vigilance system; periodic safety update reports; and device-specific vigilance. We summarise below some of the key points from each piece of guidance. 

Guidance on Implementation

  • Scope: the Regulations apply to Great Britain (England, Wales and Scotland). Medical devices placed on the market or put into service in Northern Ireland must follow separate PMS rules as set out in EU MDR 2017/745 and EU IVDR 2017/746.
  • Application: Regulation 44ZD sets out the scope of Part 4A. Discontinued devices remain subject to the existing PMS requirements. However, if any devices are placed on the GB market after 16 June 2025 (the effective date for the new PMS regime), all applicable requirements must be fulfilled. The guidance states that rather than having two PMS systems in place, compliance with the new regime will generally satisfy the existing regime as the new regime is more stringent. 
  • Clarification of key terms: the guidance assists with interpreting certain definitions as set out in Regulation 44ZC along with examples. These terms include, “lifetime of a device”, “PMS period”, “serious incident”, and “serious public health threat”.
  • Requirements of the manufacturers in ensuring their devices continue to meet appropriate standards of safety and performance. Key points highlighted in the guidance are:
    • What should be covered in the manufacturer’s PMS plan (Regulation 44ZF);
    • The requirement for the manufacturer to undertake timely preventative and corrective action, including notification requirements of such actions (Regulation 44ZG);
    • Manufacturers’ reporting requirements against the PMS plan, information on the PMS report and where a manufacturer is required to produce a periodic safety update report (PSUR) (Regulations 44ZL and 44ZM);
    • Information on the medical devices vigilance system, i.e. the notification and evaluation of adverse incidents and field safety corrective actions (FSCAs) involving medical devices, including information on manufacturers’ responsibility where vigilance-related tasks have been delegated to third parties;
    • Manufacturers’ reporting requirements under the medical devices vigilance system, clarifying who must report to the MHRA, what information must be reported to the MHRA and where reporting templates can be found (Regulation 44ZC);
    • Timescales to report an adverse incident to the MHRA, noting the change in period within which manufacturers can report anticipated serious deterioration in health, from 30 to 15 days under the Regulations, and what the initial report should include (Regulation 44ZH); and
    • Information on how to report to the MHRA and how to use the MORE portal. 
  • There are also two useful summary tables showing the changes implemented by the Regulations and the requirements which apply to different types of devices. 

Supplementary guidance on a manufacturer’s vigilance system

  • Advice for manufacturers on writing clear effective field safety notices (FSNs) to communicate details of a field safety corrective action (FSCA) and how to maximise replies to them. This is supplementary to existing guidelines for writing and distributing FSNs in the guidance on GB post-market surveillance. Some key points to note include guidance on:
    • Ensuring good traceability by keeping detailed records of distributed products, including unique device identifiers;
    • How manufacturers should approach writing FSNs, including links to an FSN template and the FSN template Q&A, and how to maximise the efficacy of FSN communication; and
    • Information on the MHRA’s role when there is an FSCA and how the manufacturer can expect the MHRA to respond.
  • The MHRA also provides 29 examples of incidents involving devices in the UK that manufacturers must report to the MHRA under the vigilance system, with a rationale for each incident to help explain why the scenario should be reported.

Guidance on periodic safety update reports for approved bodies

  • Detailed guidance for approved bodies on how to review and format periodic safety update reports (PSURs). Some key points to note include:
    • Scope: confirmation that approved bodies only have obligations regarding PSUR under regulation 44ZM when they have a contract with a medical device manufacturer and have issued a UK Conformity Assessed conformity assessment certificate for a device which has been placed on the GB market; and
    • Responsibilities and exclusions: key responsibilities of approved bodies in relation to PSUR documents, timeline for the review and instances where approved bodies are not required to review PSURs.
  • The MHRA also provides a standardised format for PSURs that outlines what information should be included within each section and how it should be presented.

Device-specific vigilance guidance 

  • The MHRA provides guidance for manufacturers on reporting adverse incidents with different technologies including intraocular lenses, neurostimulators, breast implants and insulin pumps, under the vigilance system.

If you have any questions about regulatory compliance, please contact our Healthcare team. 

This article was written by Scarlett Sullivan and Fraser Campbell.