Strategic Scenarios for PMS Data Management in EU and GB

What are the New PMS Requirements for Medical Devices in Great Britain?

In 2024, the UK government put in force legislation to clarify and strengthen the Post-Market Surveillance (PMS) requirements for medical devices placed on the Great Britain (GB) market.

The new set of regulations (Statutory Instrument 2024 No. 1368) amends the UK Medical Devices Regulations 2002 by inserting a new Part 4A on PMS requirements for Medical Devices (MDs), including in vitro diagnostic devices and active implantable medical devices aiming at facilitating a greater traceability of incidents and trends and allow the Medicines and Healthcare products Regulatory Agency (MHRA) to act swiftly when needed.

When do the New GB PMS Rules Come Into Effect?

These requirements apply to all the MDs placed on the market or put into service in GB (England, Wales and Scotland) from 16 June 2025 onwards, regardless of certification. They are therefore applicable to both CE marked and UKCA marked MDs.

What do Manufacturers Now Need to do to Comply?

Based on the PMS key changes, manufacturers are now required to:

· Consider new PMS definitions and requirements in their quality management system (QMS);

· Prepare a PMS plan that includes user experience data;

· Put in place systems to gather PMS data from the GB market able to collect and assess real-world safety and performance data;

· Prepare and update a Post-Market Surveillance Report (PMSR) every 3 years or prepare a Periodic Safety Update Reports (PSUR) using a standardised format and update it at set intervals;

· Report serious incidents to the MHRA within 15 days (previously 30);

· Identify any trends in incidents and if applicable, reporting those trends;

· Notify the UK Responsible Person (UK RP) and approved body (if applicable) of all preventive and corrective actions taken to address a risk or non-conformity compromising the performance or safety of the device;

· Notify the MHRA of any Field Safety Corrective Action (FSCA) implemented outside GB related to a device which is of the same model as the device that has been placed on the market or put into service in GB;

· Submit Field Safety Notices to the MHRA for review before sharing with users;

· Provide MHRA any information requested relating to an ongoing incident investigation or FSCA, PMSR or PSUR within 3 days of request.

Comprehensive guidance is available on GOV.UK to support manufacturers in the implementation of new requirements.

What Challenges do Manufacturers Face with GB PMS Implementation?

Although the new PMS regulation lays the groundwork for future reforms, including potential international recognition routes on a manufacturers point of view, this situation poses some challenges.

A first challenge is the short time frame accorded for adapting to and integrating mandatory, more structured, and active PMS requirements into existing systems. Manufacturers must establish effective traceability systems able to discriminate device place on different market even in case of complex logistic supply chains, proactive data collection systems, update their QMS and technical documentation to ensure ongoing compliance with the new rules. The six months transition period is now ended. The regulation also empowers MHRA to request a PMS and PMSR at any time, and the manufacturer or UK RP must be able to deliver it within 3 working days. However, not all the GB and European Union (EU) manufacturers have still implemented the changes needed.

How Should Manufacturers Manage Devices Placed on the Market Before and After June 2025?

A second challenge concerns the management of devices placed on the market prior and following 16 June 2025. MDs commercialised before 16 June 2025 remain subject to the prior PMS requirements set out in the relevant legislation and detailed in the MEDDEV 2.12 on Post-Market Surveillance. This means that two different processes may be implemented as two sets of GB PMS requirements will apply depending on when the devices were placed on the market. In order to comply to these requirements more efficiently, manufacturers may find it more straightforward to implement a single PMS system for all their GB devices. As the new PMS requirements are generally more stringent than before, meeting these is expected to fulfil prior requirements, although each manufacturer should check the feasibility for their MDs.

Should Manufacturers Merge or Split PMS Systems for EU and GB Markets?

The last and more relevant challenge is the strategic decision of manufactures who commercialise devices on EU and GB market: create dedicated process and documentation for each market (split scenario) or integrate the existent ones, trying to satisfy the specific, and sometimes divergent, requirements of both (merge scenario).

How do GB PMS Regulations Differ from EU MDR and IVDR?

Manufacturers who place on the market or put into service MDs in EU including Northern Ireland (NI) must follow EU Medical Device Regulation (2017/745) (MDR) and the In Vitro Diagnostic Medical Device Regulation (2017/746) (IVDR).

New UK regulations align GB PMS requirements closely with the ones of the EU, particularly in their core principles. The documental structure of the PMS system between GB and the EU is identical as both includes PMS Plans, PMSRs, and PSURs. The vigilance and PMS requirements are similar, thus prone for the implementation of cost and time effective merge strategies. However, there are some insidious differences that require careful and case by case evaluation.

How can Manufacturers Streamline PSUR Reporting Across EU and GB?

In December 2022 EU Medical Device Coordination Group released the MDCG 2022-21 “Guidance on periodic safety update report (PSUR) according to regulation (EU) 2017/745 (MDR)” guidance that represents the state of the art for EU PSUR.

In June 2025, the MHRA, released its standardised format for the GB PSUR.

Even though according to the MHRA guidance “Guidance on periodic safety update reports (PSUR) (regulation 44ZM) for approved bodies”, the UK Authorised Bodies (UKABs) must ensure that manufacturers have provided the necessary data in accordance with the standardised format, the MHRA recognises that a UKAB may be affiliated with an EU notified body and that a combined PSUR report format may be used as long as it demonstrates that the GB requirements have been met. Based on the above, PSURs produced according with EU MDCG guidance, may be updated with specific information referred to the GB market in order to maintain a sole PSUR.

However, the degree of acceptability of this approach by UKAB is currently not clear nor if this approach is limited to circumstances in which a formal affiliation is in place or in which the devices covered by the PSUR are under the same conformity assessment body for the UKCA-mark and CE-mark. On other hand, there are no evidence supporting the acceptability of GB PSUR by EU Notify Body (NBs) and Competent Authorities.

According to MDR, the technical documentation (including PSUR) shall be presented in a clear, organised, readily searchable and unambiguous manner. Integrating GB vigilance and PMS data in a PSUR prepared in accordance with MDCG guidance may compromise its clarity and readability, potentially confusing auditors who are increasingly focused on strict adherence to the MDCG PSUR format.

What are the Risks of Poorly Implemented PMS Strategies?

In conclusion, the new PMS framework for GB medical devices aims at closing historical gaps with a more rigorous approach. Although inspired by international best practice and EU MDR, significant differences remain. While combining EU and GB PMS reporting can be an efficient solution, it requires a meticulous and strategic approach. Manufacturers must review EU and GB current legislation and guidance alongside their processes and procedures, take deliberate steps to clearly identify GB relevant data, perform targeted analyses for the GB market and integrate their EU documents to align with MHRA guidance. When poorly implemented, this strategy may lead to delays, requests for clarification, or even regulatory enforcement actions. If executed correctly, it strongly supports both efficiency and regulatory compliance.

Disclaimer. The views and opinions expressed in this article are solely those of the author and do not necessarily reflect the official policy or position of Test Labs Limited. The content provided is for informational purposes only and is not intended to constitute legal or professional advice. Test Labs assumes no responsibility for any errors or omissions in the content of this article, nor for any actions taken in reliance thereon.