[2025-09-05] On September 5, 2025, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published a standard template for the post-market surveillance report (PMSR) for medical devices (MDs) and in vitro diagnostic medical devices (IVDDs).
Context
Post-market surveillance (PMS) is one of Great Britain’s priorities for the regulation of MDs and IVDDs in 2025. The regulations modifying the PMS requirements for Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain)
A previous network article summarizes the work carried out by the MHRA on this subject.
PMSR for manufacturers
The guide entitled “Medical devices: Standardised format for the post market surveillance report” joins the other guides dealing with PMS.
This web page is mainly used to download the PDF document: “The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 – Standardized format for post-market surveillance report (PMSR)” (17 pages).
The guide thus details the standard format expected for the PMSR report, drawn up by manufacturers and intended for the MHRA.
Difference between PMSR and PSUR
We have already mentioned the publication of a guide for the PSUR (Periodic Safety Update Report) in July 2025. A
Any manufacturer who places a medical device on the market or in service in the UK is required to produce either a Post-Marketing Surveillance Report (PMSR) or a Periodic Safety Update Report (PSUR). The applicable obligation varies according to the risk class of the device as defined by current legislation, with higher class devices subject to enhanced regulatory control.
However, there are several notable differences between the PMSR and the PSURs:
- Devices covered:
- PMSR is required for class I MDs (all categories) and class A (all categories) and class B IVDDs;
- whereas PSUR covers class IIa to III medical devices (including implantables) and class C and class D IVDDs, as well as IVDDs in lists A and B of Annex II to Directive 98/79/EC.
These reports are not required for custom-made devices or systems and procedure packs when the final device is not UKCA or CE marked when it is placed on the market or made available in the UK.
- Update frequency:
- Every 3 years for PMSR ;
- Every 2 years for PSURs for Class IIa MDs (including implantables);
- Every (1) year for PSURs covering higher-class MDs and IVDDs.
- Involvement of UK approved bodies (UKAB):
- It is not required for PMSR ;
- UKABs must review PSURs covering Class IIa and IIb MDs (excluding implantables);
- UKAB to review AND report on PSURs for other MDs classes. This section is not applicable to class C and D IVDDs, until a UK regulatory framework emerges for these products.
It is not necessary to systematically send the PMSR or PSUR to the MHRA. However, these documents must be ready to be sent to the MHRA on request.
The MHRA also specifies that it is not mandatory to include sections that are not applicable, with documented justification. Data may also be presented in another form if necessary. As in the case of PSURs, this gives manufacturers a certain amount of latitude in drafting the PMSR.
Conclusion
For its PMSR and PSUR templates, the MHRA has adopted an approach inspired by European regulatory requirements. With very similar content and data, PMSRs and PSURs can easily be shared between Europe and the UK (taking care to highlight UK-specific data).
If you’d like to find out about or recall all the requirements for PMSR in Great Britain, please consult the guide “Requirements of the manufacturer’s PMS system” (in particular point d).
Article written by Christophe Saillet, member of the DMEXPERTS network.