The Medicines and Healthcare Products Regulatory Agency (MHRA) is responsible for ensuring that medicines and medical devices placed on the UK market are safe to use. The MHRA’s activities are undergoing significant regulatory reform in 2025 to continue ensuring medical product safety while making the market more accessible for suppliers of innovative treatments and technologies.
In December 2024, the MHRA published a roadmap with its plans for these reforms, divided into four key updates:
- new regulations for post-market surveillance (PMS),
- new regulations for pre-market requirements,
- policy development, and
- additional guidance for software including AI and digital mental health products.
Manufacturers and suppliers of medicines and medical devices should familiarise themselves with the roadmap to prepare for the new obligations and guidance that may impact their operations.
New regulations for PMS
The PMS regime requires manufacturers to continuously monitor the effectiveness of medical devices once they are placed on the market in Great Britain. Regulations to update the PMS requirements were laid before Parliament in October 2024 and will come into force on 16 June 2025.
Once enforced, the regulations are intended to introduce “clearer and more risk-proportionate” PMS requirements, ensuring the safety of medical devices and providing greater certainty for manufacturers.
The primary goals of the new PMS requirements are to enhance the traceability of device safety incidents and enable swift responses to prevent patient harm. The changes will include enhanced data collection and performance reporting obligations for manufacturers across a medical device’s lifespan, and shorter timeframes for serious incident reports.
The MHRA has published guidance to help manufacturers prepare for compliance with the new rules before they take effect in June 2025. This includes advice on writing and issuing effective “field safety notices”, used to inform customers of the corrective action the manufacturer is taking to prevent or reduce the risk of a serious incident in relation to a device which has already been placed on the market or put into service.
The MHRA considers the new rules to be a “foundation for patient safety”, which will be followed by the additional planned reforms. Manufacturers who consult the guidance now can prepare for the new obligations and adopt enhanced product monitoring as best practice.
New regulations for pre-market requirements
Medical devices must comply with regulatory standards before being placed on the market in the UK. This is usually achieved by passing a UK Conformity Assessment (UKCA), which replaced the EU’s CE marking system after Brexit. Although CE-marked products can still be sold in the UK without also obtaining a UKCA mark, the plan is to eventually require all products to be individually assessed under the new UKCA system.
In light of this, the MHRA has consulted on reforms to the UK’s marking system to ensure that products can easily access the UK market. The consultation focuses on four key policy areas:
- International reliance system – As CE-marked products will no longer be automatically permissible in the UK, the MHRA has proposed a system that will allow medical devices to more easily access the Great Britain market if they are already authorised in a comparable jurisdiction (the MHRA has so far specified the EU, US, Canada and Australia).
- Changes to UKCA marking – Whilst medical devices must currently display a UKCA mark, the MHRA has proposed a new Unique Device Identification (UDI) that will be assigned to devices, which will improve traceability and remove the need for a physical UKCA mark.
- Classification of in-vitro diagnostic (IVD) devices – Four separate risk classes have been proposed for IVD devices, with categorisation based on risks to patients and public health.
- Revocation date for EU legislation – The statutory framework for medical devices includes various pieces of assimilated EU law which will be revoked after a certain date. The MHRA has proposed that, for select legislation, the revocation date is removed so that they remain in force whilst the new regime is still in development.
The MHRA has indicated that results of this consultation will be published in Spring 2025. Following this, a new statutory instrument will be debated in Parliament at the end of the year, with plans to bring new rules into force in 2026.
Policy development and additional guidance for software
The roadmap’s third and fourth updates relate to policy development initiatives and new software guidance. These include:
- Guidance for “exceptional use” authorisations – These allow a medical device to be sold even when they are not UKCA-marked, if it is needed to protect a patient’s health and there is no legitimate alternative.
- Policy intent for the Early Access to Medicines Scheme (EAMS) – The MHRA currently operates EAMS to grant patients with serious conditions access to medicines that are not yet otherwise authorised.
- Guidance for Good Machine Learning Practice (GMLP) – The MHRA has previously identified 10 guiding principles for GMLP in collaboration with the US and Canada.
- Guidance for AI Development and Deployment, and cybersecurity guidance for Software as a Medical Device – The MHRA contains a “Software Group” with responsibility for ensuring the safety of AI and software medical device technologies.
- Guidance for Digital Mental Health technology – Since 2023 the MHRA has collaborated on a project with the Wellcome Trust to improve the regulation of these technologies and make them safe and effective.
EU developments
The MHRA’s plans should also be considered in light of the EU’s new framework for Health Technology Assessments, which was formally introduced through new legislation in January 2025. The new rules are designed to facilitate greater collaboration between Member States and increase the efficiency with which new medical technologies reach the single market.
Once fully implemented, the new framework allows for “Joint Clinical Assessment”, for high risk medical devices. This allows for a single submission file at the EU level, rather than make several national submissions. The framework is intended to apply from 2026 onwards.
Next steps
The next major legislative change will be to the PMS rules, and manufacturers are advised to consider their obligations now and consult the MHRA’s guidance so that they are prepared ahead of the new regulatory regime in June. Beyond the changes to the PMS requirements, manufacturers should also consider the effect of the upcoming reforms outlined above, and stay up-to-date with the guidance on these topics, which will be published by the MHRA throughout 2025.
If you require advice on your obligations when manufacturing or selling medicines and medical devices in Great Britain, please contact a member of our life sciences team.
Gustaf Duhs
George Harrington