The UK has just rolled out one of its most impactful regulatory changes since Brexit — a new set of post-market surveillance (PMS) requirements for medical devices. Here’s what manufacturers, UK Responsible Persons, and industry stakeholders need to know to stay compliant.
What are the new UK PMS requirements for medical devices?
n December 2024, the UK government enacted a major change in medical device regulation: the introduction of a Post-Market Surveillance (PMS) obligation for all devices placed on the Great Britain market.
The new regulation, issued by the MHRA (Medicines and Healthcare products Regulatory Agency), applies to both CE-marked and UKCA-marked devices. The official compliance deadline is June 16, 2025.
This new law requires manufacturers to actively monitor and report device performance and safety post-market through structured data analysis and reporting.
“This isn’t just for UKCA-marked products. Even if you rely on CE-marking, you still need to follow the UK PMS rules,” said Claire Dyson, Head of Approved Body at DQS, during a recent podcast.
Who must comply with the UK Post-Market Surveillance regulation?
The PMS regulation applies to all medical device manufacturers and UK Responsible Persons (UKRPs) who place devices on the Great Britain market, including:
- All medical device classes: Class I, IIa, IIb, III, and active implantables
- Software as a Medical Device (SaMD)
- Devices marked with CE or UKCA
Exemptions apply only to:
- Devices used for clinical investigations
- IVDs under performance evaluation
- Devices approved for exceptional use (e.g., humanitarian or military)
- Custom-made devices (partially exempt)
Note: Northern Ireland continues to follow EU law, but MHRA still oversees registration.
What is the UK PMS compliance deadline?
- Regulation published: December 2024
- Transition period ends: June 16, 2025
This gives manufacturers six months to adjust quality systems, documentation, and reporting structures to align with the new MHRA guidance.
The regulation also empowers MHRA to request a PMS report at any time, and the manufacturer or UKRP must be able to deliver it within 3 working days.
What’s different from EU MDR post-market surveillance?
While PMS is already a core part of EU MDR, the UK regulation introduces key differences:
- Greater prescriptiveness: MHRA outlines timelines, formats, and expectations
- Mandatory segmentation of GB data in reports
- Use of MHRA-provided templates for consistency
- Direct submission to MHRA (not via notified bodies) for CE-marked devices on GB market
“The UK is not asking you to duplicate your reports,” Dyson said, “but to make sure GB data is clearly identified and accessible.”
If you already comply with EU MDR, your current PMS systems provide a good foundation — but you must adapt the presentation of your data to match UK expectations.
How often do PMS reports need to be submitted?
Reporting frequency is based on the risk classification of the device:
| Device Class | Frequency |
|---|---|
| Class III & active implants | Annually |
| Class IIb implants | Annually |
| Class IIa, IIb (non-implants) | Every 2 years |
| Class I (self-declared) | Every 2 years or upon request |
Manufacturers should ensure no gaps in PMS coverage, and ideally align reporting cycles across EU and UK to reduce duplication.
What do UK Responsible Persons (UKRPs) need to do?
The PMS regulation expands the responsibilities of UKRPs. In addition to registering devices and retaining technical documentation, they must now:
- Request and store UK-compliant PMS plans and PSURs
- Submit documents to MHRA within 3 days if requested
- Monitor manufacturer compliance and escalate contractually if documents are not received
If the UKRP cannot provide the required documentation, MHRA may hold them accountable, particularly in cases of non-cooperation from the manufacturer.
What if you miss the June 2025 PMS deadline?
Failing to comply with the UK’s new Post-Market Surveillance (PMS) requirements by June 16, 2025, can have serious consequences for medical device manufacturers and their UK Responsible Persons. The MHRA (Medicines and Healthcare products Regulatory Agency) has made it explicitly clear: compliance with PMS obligations is mandatory, even for devices that are CE-marked and not UKCA-certified.
The most immediate risk is the loss of market access in Great Britain. Without demonstrating compliance, manufacturers may no longer be legally allowed to place or keep their devices on the GB market. This can directly halt product distribution, sales, and availability, impacting both revenue and patient access.
Beyond access issues, MHRA may initiate inspections or enforcement actions. These could include formal requests for documentation, warning letters, or investigations into a manufacturer’s post-market activities. Since MHRA now requires that PMS documentation be provided within three working days of a request, any delay or lack of preparedness could escalate the situation quickly.
Another potential consequence is delisting from the MHRA device registration database. This is critical, as product registration is a legal requirement for all devices (CE or UKCA) in the UK. Delisting can create legal liabilities and immediately interrupt commercial operations, especially for distributors, healthcare providers, and supply chain partners relying on visible product approval status.
Equally important is the reputational damage that non-compliance can cause. Regulatory red flags can undermine trust with importers, healthcare institutions, and even investors. Once flagged, a manufacturer may face additional scrutiny not just from MHRA but also from EU notified bodies, other national authorities, and clients globally.
In short, non-compliance with the June 2025 PMS deadline isn’t just a missed task — it’s a business risk. Companies that do not treat this seriously risk regulatory penalties, commercial disruption, and reputational harm. The smart move is to prepare now, ensure documentation is audit-ready, and collaborate proactively with your UK Responsible Person to ensure full alignment with MHRA expectations.
How can manufacturers prepare?
With only a few weeks left until the June 16 deadline, here’s what medical device companies should do now:
- Read the MHRA PMS guidance carefully (link)
- Perform a gap analysis against existing PMS processes
- Update QMS to reflect UK-specific requirements
- Adjust PSUR templates to segment GB-specific data
- Train internal teams and regulatory affairs personnel
- Collaborate with your UKRP to confirm reporting processes and deadlines
Should you combine EU and UK reports?
Yes — in many cases, manufacturers can combine their EU MDR and UK PMS reports into a single document. This approach can help streamline reporting processes, reduce duplication, and maintain consistency across regulatory submissions. However, this strategy comes with important caveats that must be followed to ensure compliance with MHRA expectations.
First and foremost, the combined report must include segmented data for Great Britain. The MHRA requires that any analysis relevant to the UK market be easily identifiable, whether through a separate section, annex, or a marked column in tables and charts. Simply inserting global or EU-wide data is not enough — the information must specifically address performance and safety observations related to the GB market.
In addition to segmentation, the report must provide UK-specific trend analysis. This includes summarizing how complaints, adverse events, or product performance may differ in Great Britain compared to the European Union or other markets. MHRA expects manufacturers to monitor trends that may arise in the UK context, including regional usage patterns, population-specific feedback, or healthcare system variables.
Furthermore, the combined report should contain annotations or explanations that meet MHRA’s formatting and content expectations. This includes aligning terminology with UK definitions and, where possible, referencing MHRA guidance documents or using official templates to organize your report. While formatting may vary slightly between jurisdictions, clarity and accessibility for the MHRA reviewer are key.
To support this process, the MHRA has published structured templates and reporting tables that manufacturers are encouraged to use. These tools help create consistency and ensure all required elements are addressed. Leveraging these templates not only improves compliance but also enhances the professional presentation of your submission, making regulatory interactions more efficient.
In summary, while combining EU and UK PMS reporting can be an efficient solution, it must be done carefully. Manufacturers must take deliberate steps to highlight UK-relevant data, conduct GB-specific analysis, and format their documents to align with MHRA guidance. When done properly, this approach balances efficiency with compliance, but when done poorly, it can result in delays, requests for clarification, or even regulatory action.
Why is the UK focusing on PMS?
The MHRA has emphasized that PMS offers early visibility of product issues — a vital tool for public health and device regulation. The move also supports broader discussions about international regulatory reliance, where countries might begin recognizing one another’s surveillance data to avoid duplicative audits and certifications.
Whether or not UKCA marking becomes mandatory again in the future, PMS compliance is a non-negotiable foundation for maintaining UK market access.