Post-Market Surveillance (PMS) in Great Britain from June 2025: What manufacturers need to know and do now

Manufacturers of medical devices and in vitro diagnostic devices (IVDs) placing their products on the British market must prepare for new regulatory obligations: From June 16, 2025, new requirements for post-market surveillance (PMS) will apply. This article outlines the specific changes that will come into effect, how to adapt your PMS system accordingly, and how to leverage synergies with existing EU processes (MDR, IVDR) so that you remain on the safe side from a regulatory perspective.

While the European Union (EU) has established harmonized regulatory frameworks through the Medical Device Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), Great Britain (GB) has been pursuing its own regulatory path since Brexit. Now, a significant development is on the horizon: on June 16, 2025, enhanced requirements for post-market surveillance (PMS) will come into force. These changes are intended to structure the monitoring of medical devices and in vitro diagnostic medical devices (IVDs) after they have been placed on the market in Great Britain and align the requirements with current regulatory standards.

But what exactly is changing, which deadlines are relevant, and how can companies develop a practical strategy to implement the new requirements? In this article, we provide you with a structured overview of the key changes and outline the steps that you should now be taking.

The new regulatory basis for PMS in Great Britain

Following Brexit, Great Britain initially retained its Medical Devices Regulations 2002 without changes. However, with the increasing demands on the safety and performance of medical devices and IVDs, it became clear that a legislative update was necessary. As a result, the regulatory authority in the United Kingdom (UK), the Medicines and Healthcare products Regulatory Agency (MHRA), initiated a phased revision of the existing legislation. A central component of this revision is the new section Part 4A, which defines the legal requirements for the PMS system in Great Britian.

Please note: These regulations apply exclusively to Great Britain (England, Scotland, and Wales). Northern Ireland remains subject to EU requirements under the Protocol on Ireland/Northern Ireland (Northern Ireland Protocol (NIP)) and therefore follows the MDR and IVDR and is not addressed separately in this article.

The new PMS requirements will officially take effect on June 16, 2025. From this date, they will apply to:

• All medical devices and IVDs with UKCA (UK Conformity Assessed) marking
• CE-marked products under MDR/IVDR which may continue to be sold in Great Britain until June 30, 2030

Products which are marketed exclusively in Northern Ireland or which are withdrawn from the British market before June 16, 2025, are not affected.

The new requirements are modelled on the EU regulations but differ in important details such as reporting timelines, documentation structure, and specific PMS processes. Manufacturers operating in both Great Britain and EU markets (or the whole of the United Kingdom) therefore face the challenge of establishing a PMS system that meets both sets of regulatory requirements.

Core PMS requirements in Great Britain – and parallels to MDR/IVDR

With the introduction of Part 4A, Great Britain is setting new standards for the PMS system, intended to ensure that medical devices and IVDs remain safe and effective throughout their entire lifecycle.

Although Great Britain is not introducing an entirely new regulatory system, the PMS requirements are now clearly structured and supported by detailed obligations for manufacturers. A closer look at the new requirements reveals the specific obligations for manufacturers and where synergies with MDR and IVDR can be used.

Mandatory PMS system and PMS plan

Manufacturers must implement a structured PMS system that not only captures all safety- and performance-related data but also ensures continuous evaluation of product performance and potential risks throughout the product lifecycle. The system must be supported by a PMS plan that defines the methods for data collection, risk assessment, and the reporting of safety risks.

These requirements are similar to those under the MDR and IVDR, meaning that companies with an established PMS system will often only need to adapt it to British requirements.

New reporting obligations and the standardized PSUR format

A key component of the new requirements is regular reporting through Periodic Safety Update Reports (PSURs) and PMS reports.

Depending on the risk class, the following reporting obligations apply:

• Lower-risk devices (Class I, A, B): PMS report every 3 years
• Class IIa devices: PSUR every two years
• Higher-risk devices (Class IIb, III, C, D, implantable devices): annual PSUR

The MHRA provides manufacturers with a standardized format for compiling PSURs, which is closely aligned with the EU guidance on PSURs (MDCG 2022-21). While there are many similarities in content and structure with the EU guidance, there are some specific differences:

• Regional data segregation: The MHRA requires a separate regional breakdown for data relating to the United Kingdom (UK), with a possible further distinction between Great Britain and Northern Ireland.
• Greater emphasis on real-world data (RWD): The MHRA’s guidance places particular emphasis on the inclusion of specific data sources on product safety and performance that go beyond traditional PMCF studies.

For manufacturers already working under MDR/IVDR, a key advantage lies in the potential to harmonize data collection and analysis processes in order to fulfil the requirements of both systems efficiently.

Incident Reporting and Trend Analysis

The new British requirements will introduce expanded obligations for the reporting of serious incidents and trends. Reporting timelines are broadly similar between the EU and Great Britain, but responsibilities differ since the EU authorities and the MHRA operate independently. Companies with products in both markets (or the whole of the United Kingdom) must ensure that their PMS systems are capable of coordinating different reporting processes - including submitting separate reports to the MHRA, even if the incident occurred in the EU and has already been reported to the competent national authority there.

Additionally, manufacturers must implement trend reporting to identify significant changes in the frequency or severity of incidents and notify the MHRA accordingly. This requirement also aligns with the MDR and IVDR, meaning that existing systems can generally be used with appropriate adjustments.

Strategic Approaches to Implementation – How to Leverage Synergies Between the EU and GB

With the new PMS requirements, many companies are asking how they can efficiently adapt their existing systems. Maintaining completely separate documentation for the EU and Great Britain would be highly resource-intensive, while full harmonization may not always be practical.

The good news: due to the similarity between the British and EU PMS requirements, there are various opportunities to optimize processes by aligning PMS documentation, reporting cycles, and data collection methods across the two regulatory frameworks.

The most appropriate strategy depends on several factors – from the size of the product portfolio to the availability of internal resources. What’s crucial is that manufacturers start adapting early to avoid regulatory risks from June 2025 onwards.

Effective Date June 16, 2025 – Which documents must be in place?

From June 16, 2025, manufacturers placing products on the market in Great Britain must have a PMS system and PMS plan in place for their products. In addition, processes for trend reporting and vigilance must be implemented to ensure the systematic collection and reporting of safety-related data.

There is no requirement to retrospectively create PMS Reports and PSURs, but data collection must begin from the effective date to allow the first reports to be compiled in line with the applicable reporting obligations in the following years.

Take action now to ensure regulatory compliance

The new PMS requirements for the UK will come into force on June 16, 2025, and will require manufacturers to implement clear structures, coordinated processes, and robust documentation. While the similarities to the MDR and IVDR offer opportunities for harmonization, the specific differences - particularly regarding reporting obligations and regional data formatting - make strategic planning essential.

Companies should now address the following questions:

• What adjustments are needed to meet the new UK requirements?
• Where can synergies be leveraged between the PMS process in the EU and the UK?
• Which documents and processes need to be updated?

The answers will vary from company to company – but the sooner you act, the better you can mitigate regulatory risks and improve your internal operations.

Benefit from our expertise! Learn how we can help you align your PMS system with the new British requirements and support you efficiently throughout the implementation process. Let’s start the conversation.