MHRA’s Risk-Based PMS: What’s Actually New in Great Britain (since 16 June 2025)

As many across the MedTech industry have already noticed, since June 16, 2025, Great Britain has been operating under a new, risk-based post-market surveillance (PMS) system and manufacturers are now navigating its first months of implementation.

This amendment to the UK Medical Devices Regulations (UK MDR 2002) brings a sharper focus on proactive, data-driven quality management and applies to all devices placed on the Great Britain market, including general, active implantable, and in vitro diagnostic (IVD) devices, whether CE- or UKCA-marked.

Beyond broad EU alignment, the UK version clarifies expectations (lifetime vs. PMS period), introduces standardised PMSR/PSUR formats, and sets clear cadences and three-day document access.

The shift marks a move from static compliance to continuous, risk-proportionate surveillance – a regulatory system designed for ongoing evidence rather than one-time validation.

What’s Changed?

The update broadly aligns with the EU MDR, but the UK version goes further. So, what does this actually mean in practice?

The new framework introduces a risk-based post-market surveillance system that raises expectations for proactive, continuous quality management.

Among the most significant updates are:

• Enhanced collection of real-world data: Manufacturers must now take a harmonised approach to gathering and analysing how devices perform in real-life use, improving early detection and trend recognition of safety or performance issues.

• Clearer thresholds for trend and incident reporting:  The regulation clarifies when and how manufacturers must escalate patterns of adverse events, ensuring consistent linkage between trending and CAPA.

• Clearer expectations for reporting:  Timelines for serious incidents remain aligned with EU MDR (15/10/2 days), but the MHRA places stronger emphasis on adherence and document accessibility.

• Introduction of trend and summary reporting: Manufacturers are expected to monitor and analyse device performance continuously, identifying patterns and emerging issues before they escalate.

• Clearer duties for risk mitigation and communication: Companies must not only identify risks but also document and act on them, including prompt user notifications when safety concerns arise.

• Standardised templates for PMSR and PSUR: The MHRA introduces a unified structure for reporting, helping manufacturers maintain consistency and transparency across their surveillance activities.

Key Definitions

The new PMS regulation also clarifies several core terms that define how long data must be collected and retained.

In particular:

How Does This Differ from the EU MDR?

While the UK’s PMS framework aligns closely with the EU MDR, it introduces several clarifications and refinements.

Among them are clearer definitions for Lifetime (from manufacture to the end of validated performance) and PMS period (from the first market entry to the end of the last device’s lifetime), which establish firmer boundaries for data collection and retention.

In short, the UK has added clarity, consistency, and a stronger connection between post-market data and risk management.

But Who Needs to Act & When?

With the regulatory lines now drawn, the next question is clear: who needs to act, and when?

It applies to:

• All manufacturers (general medical, active implantable, and IVD) placing devices on the GB market on or after 16 June 2025, regardless of CE or UKCA mark.

• UK Responsible Persons and any authorised representatives reporting on a manufacturer’s behalf.

Exemptions include in-house manufactured devices, those under clinical investigation, and discontinued models withdrawn before the enforcement date.

If you’re a PMS specialist: Attenzione!

Here’s your action list for the upcoming months:

1. Map your device portfolio to the GB PMS obligations by device type and risk class (and, where applicable, determine whether a PMSR or PSUR is required).

2. Update your PMS plan: reflect the new definitions (lifetime, PMS period), include updated data sources, analysis methods, and ensure CAPA integration aligned with risk-based cadence.

3. Adopt the UK’s new standardised reporting formats for PMSR and PSUR.

4. Define risk-based cadences for trend analysis and set clear signal triggers.

5. Align vigilance workflows to GB reporting timelines and roles.

6. Plan for cut-over management for devices sold before and after June 16, ensure smooth transition or harmonise under one PMS system.

7. Maintain documentation: PMSR/PSUR must be ready for MHRA within three working days.

The MHRA has also published new standardised templates for the PMS Report (PMSR) and the Periodic Safety Update Report (PSUR). These formats are not mandatory, but recommended to ensure consistency and traceability.

While this article focuses on the broader PMS system requirements, the templates form part of the same regulatory framework and can support structured documentation.

What This Means in Practice and Why It’s Harder

For many manufacturers, the shift to a risk-based PMS system will mean more documentation, more structure and less room for improvisation.

Under the new MHRA framework, post-market surveillance is no longer a periodic exercise but a continuous data loop that requires active trending, traceable CAPA links, and documented evidence of every decision.

In practice, that means PMS plans need more frequent updates, complaint data and vigilance findings must be consolidated faster, and PMSR/PSUR submissions will need to follow the MHRA’s new structured formats.

For regulatory teams, the challenge is balancing this new level of operational discipline with limited time and resources.

Which leads us to the heart of it all: what we at Flinn believe defines this new era.

Finding the Balance: Flinn’s Approach to the New PMS Era

At the heart of the new UK PMS regulation lies a familiar truth, one that has guided our work at Flinn from the very beginning:

Post-market surveillance is about balance.

A balance between maximising patient safety and minimising time investment. Between staying vigilant and staying efficient. Between meeting regulatory expectations and building long-term quality confidence.

The new MHRA framework doesn’t simplify the work, but it gives it structure. And with the right technology, structure turns into opportunity.

That’s exactly what we focus on at Flinn: connecting supplier, product, and process data with vigilance insights to detect trends early, before they turn into cost, risk, or recall.

Ready to make your PMS truly risk-based?
Contact us to see how Flinn connects data, compliance, and confidence.