EU Commission Launches Call for Feedback: Targeted Revision of the MDR & IVDR (8 Sep–6 Oct 2025)
8 September 2025
MDCG Working Group Releases Draft Version of Manufacturer Trend Report Form & Guidance Docs
16 September 2025PMS Report Guidance
The MHRA’s guidance for Post-Market Surveillance (PMS) Reports is available: HERE
What is included in the guidance?
This document helps guide manufacturers on what to include in a PMS Report (PMSR), acting as a quasi-template.
Note that not all sections will be applicable. Further, it is intended as guidance, and not a mandatory form. Meaning, the manufacturer may provide data in an alternate format, as long as the minimum information is supplied.
The sections covered are:
- Cover page
- Executive summary
- Device performance information, such as on serious incidents, other incidents, and other side-effects, FSCAs, trends, user feedback and complaints, real-world data sources, and comparison with similar devices
- Preventative and corrective actions
- Findings and conclusions, such as validity of the data, overall conclusions from the data analysis, and actions taken to address the conclusions
Which class devices require a PMSR?
PMSRs are required for the following devices:
- Class I medical devices
- Class A or B IVDs
- IVD devices not identified in Annex II, List A or List B, of Directive 98/79
Periodic Safety Update Reports (PSURs) are required for all other devices.
How often is a PMSR required?
The MHRA requires a PMSR to be generated at least every three years. This is different from the EU MDR/IVDR, which requires that the “report shall be updated when necessary”.
Do CE Marked devices require a PMSR?
This requirement applies to all devices placed on the Great Britain* market, whether CE or UKCA Marked. Meaning, if you have registered your device with the MHRA and are placing it on the market in Great Britain, you should generate a PMSR (or PSUR, as applicable) within the required timeframes.
However, technically the UK MDR 2002 (No. 618 as amended) cannot require manufacturers of CE marked devices, to amend their CE technical documentation with information learned from the UK PMS report. It can only require manufacturers of UKCA marked devices to do this. Despite this, the MHRA’s guidance notes that the “MHRA expects manufacturers to apply the same principles to update technical documentation for CE-marked devices placed on the GB market”.
*The UK is made up of four countries and all four countries have left the European Union:
- England, Scotland, and Wales together are Great Britain (GB)
- The fourth UK country is Northern Ireland
Due to Brexit negotiations, Northern Ireland remains part of the European market and requires compliance with the MDR/IVDR. I.e., PMS requirements under SI 2024 No. 1368 are not applicable to devices placed on the market, or put into service, in Northern Ireland. Instead, MDR/IVDR requirements are applicable in Northern Ireland.
Additional Resources
For additional resources, please read:
Provide Feedback on Designated Standards
The MHRA has initiated an open feedback period for designated standards: HERE
This survey is to collect information about:
- Which standards are used most frequently
- How useful industry finds standards, for compliance with essential requirements
- How the designated standards list could be revised to better support compliance.
The MHRA will consider the survey findings when prioritizing device standards.
The current list of designated standards under the UK MDR 2002, is comprised of the standards harmonized under the old Directives (MDD/AIMDD/IVDD).
The deadline to submit responses is by 11:59pm Tuesday 30 September 2025.
Progress on Future Regulatory Changes
MHRA Head of Diagnostics and General Medical Devices Joseph Burt recently published a blog post: HERE
He discusses upcoming plans, such as:
- The draft Statutory Instrument
for the proposed regulatory changes is in its final round of internal reviews, and a version is being prepared for the notification and publication on the World Trade Organization (WTO) website.
- Those changes include reclassifying IVDs, introducing UDI requirements, and implementing an international reliance program.
- The MHRA will create training materials about certain parts of the new statutory instrument.
- The IVD team is working on an updated IVD roadmap. It was originally intended to be published last July 2024, but was paused due to external factors. This gave them “the chance to update and improve the roadmap, bringing together the latest and most innovative work in IVDs across the UK”. And take into account “new technologies, the need for strong data integrity, and the ability to respond quickly to emerging health challenges”.
