MHRA regulatory reform — a new chapter for medical devices in the UK

The Medicines and Healthcare Products Regulatory Agency (MHRA) is continuing to roll out a suite of reforms designed to modernise oversight, enhance patient safety and support innovation. These changes aren’t just technical — they represent a strategic pivot in how the UK governs medical technologies post-Brexit.

Here, Claire Burrows and Thorrun Govind outline the key reforms you need to know about, from post-market surveillance to UKCA, AI and more.

Strengthening post-market surveillance

At the heart of the MHRA’s reform agenda is the new Post-Market Surveillance (PMS) regime, which came into force in June 2025. This regime introduces Part 4A to the UK Medical Devices Regulations 2002, setting out clearer and more risk-proportionate requirements for manufacturers. The primary goal is to improve patient safety by identifying and addressing safety issues with medical devices much earlier. The MHRA is reforming its PMS fees and introducing a new annual fee structure starting in April 2026. This simplified model — based on Global Medical Device Nomenclature (GMDN) codes — aims to recover costs for the MHRA's post-market surveillance activities.

Manufacturers must now report serious incidents within 15 days — a significant decrease from the previous 30-day window. The MHRA has issued detailed guidance on how to draft effective Field Safety Notices (FSNs) and Periodic Safety Update Reports (PSURs), with templates and examples to support compliance. The guidance also clarifies key terms such as “PMS period” and “serious public health threat” and outlines expectations for vigilance systems, including how to report via the MORE portal.

What makes this regime particularly noteworthy is its ambition. The UK’s PMS requirements now exceed those of the EU, positioning the MHRA as a global leader in post-market oversight. For manufacturers, this means that meeting UK standards will generally satisfy EU obligations. This is a strategic advantage for companies navigating both regulatory landscapes.

Pre-market reform — from CE to UKCA and beyond

The Government made regulations (The Medical Devices (Amendment) (Great Britain) Regulations 2023) that enable CE-marked medical devices to be accepted in Great Britain for defined periods beyond 30 June 2023. This measure aimed to support the ongoing and safe supply of medical devices within Great Britain and facilitate a smooth transition towards a future strengthened regulatory framework for medical devices. However, it should be noted that a consultation on indefinite CE mark recognition is planned later this year, aiming to reduce duplication and support continued market access. 

A Unique Device Identification (UDI) system has also been proposed to improve traceability and potentially replace physical UKCA marks. 

The MHRA is also pressing ahead with long-anticipated reforms to the regulation of in vitro diagnostic (IVD) devices, adopting a more nuanced, risk-based approach. In-line with its consultation proposals, the agency will introduce a new classification system that divides IVDs into four categories — Classes A to D — based on the level of risk they pose to patients and public health. This structure aligns with international best practice, particularly the principles set out by the International Medical Device Regulators Forum (IMDRF) and is designed to ensure that regulatory scrutiny is proportionate to the potential harm that a device could cause.

To ease the transition, the MHRA will introduce an implementation period to give manufacturers time to adapt their systems and processes. The overarching goal is to strike a balance — enhancing patient safety and regulatory clarity for higher-risk devices while reducing unnecessary burdens on those producing low-risk diagnostics.

The MHRA’s International Reliance Pathway is another key development. Devices approved in the EU, US, Canada or Australia may gain streamlined access to the UK market if they meet GB equivalence standards. This approach aims to reduce duplication and accelerate access to innovative technologies.

Software, AI & digital health — regulating the future

The MHRA is also expanding its oversight of digital health and AI. 

The AI Airlock pilot programme is entering its second phase. The successful pilot phase saw four breakthrough AI technologies — including software that could help doctors create personalised cancer treatment plans and a tool to help hospitals, AI developers and regulators monitor AI performance in real time — tested in a regulatory ‘sandbox’ environment. 

While the MHRA has published guidance on Good Machine Learning Practice (GMLP), further guidance is expected on cybersecurity for Software as a Medical Device (SaMD).

In addition, the MHRA continues to support Exceptional Use Authorisations, allowing non-UKCA-marked devices to be used in urgent clinical scenarios where no alternatives exist.

The Product Regulation and Metrology Act 2025

The Product Regulation and Metrology Act 2025 — which received Royal Assent in July — provides the legislative foundation for many of these reforms. Although medical devices aren’t directly included, the Act enables secondary legislation that could modernise product regulation more broadly. It introduces new responsibilities across the supply chain — from manufacturers to online marketplaces — and includes provisions for cost recovery and enforcement mechanisms.

What does all this mean?

For legal and compliance teams, these reforms are more than regulatory housekeeping. 

They require strategic planning and organisations must:

• Review internal PMS and vigilance systems.
• Update contractual obligations to reflect new reporting timelines.
• Reassess market access strategies in light of CE mark recognition and international reliance.
• Prepare for digital health oversight, especially if developing AI-based technologies.

Talk to us

Our medical devices and health tech team is working closely with clients to ensure that they remain informed and prepared for what lies ahead. While the MHRA’s roadmap is ambitious, with the right guidance stakeholders can navigate these changes confidently.

If you’re looking for guidance, talk to us by calling 0333 004 4488, emailing hello@brabners.com or completing the contact form below.