MHRA – spring updates on the UK medical devices and clinical trials regimes

We provide a brief update on three key developments in the UK medical devices and clinical trials sectors:

• CE-marked medical devices consultation: in February 2026 the UK Medicines and Healthcare products Regulatory Agency (MHRA) launched a consultation on key changes to the rules on CE-marked medical devices in the UK. The proposals include:

  • extending current transitional arrangements for devices certified under the EU Medical Device Directive,

  • granting indefinite recognition of EU MDR and EU IVDR-compliant devices, and

  • introducing an international reliance route of CE-marked devices which fall into a higher risk class under GB rules.

• Guidance on mental health apps: the MHRA published user guidance in January 2026 for mental-health support apps to help users make informed decisions when relying on app-led advice and to understand which apps are reliable, safe and appropriate for their individual needs. This provides guidance on the line between medical devices and wellness/ lifestyle apps.

• New clinical trials regulations: on 28 April 2026, The Medicines for Human Use (Clinical Trials) Amendment Regulations 2025 will come into force after a 12-month implementation period. The new regulations have been developed by the MHRA and Health Research Authority (‘HRA’). These amendments are a significant reform of UK clinical trial regulations, and are designed to introduce alignment with international standards, to simplify the processes for sponsors, while maintaining transparency for patients.

We summarise these developments below. If you have specific questions about how the developments could impact you and your business, our team is available to assist you further.

Consultation on the indefinite recognition of CE-marked devices

It is a requirement that a public consultation is carried out before any changes are made to regulations under the Medicines and Medical Devices Act 2021. MHRA has explained that its proposals are part of larger changes to medtech regulation to realise its objective that the UK becomes one of the top three fastest countries in Europe for access to medtech by 2030.

If you are a manufacturer intending to sell medical devices on the GB market the outcome of the consultation will be significant. The consultation is open until 10 April 2026. A link to the Consultation can be found here.

1. Extending current transitional arrangements for devices certified under the EU Medical Device Directive (MDD), aligning GB timelines with the EU’s transition to the EU Medical Device Regulation (EU MDR)

The transitional arrangements that are in place following Brexit are currently due to end on 30 June 2028. If this change is implemented, devices approved under MDD could be placed on the GB market until 31 December 2028. The proposal is being made to reduce the risk of supply disruption, as around 90% of medical devices currently used in GB are CE marked.

2. Indefinite recognition of EU MDR and EU IVDR-compliant devices, to reduce the risk of interruption to the supply of medical devices for patients in GB.

Recognition of EU MDR and EU IVDR-compliant devices expires on 30 June 2030. This proposal is designed to ensure patients continue to have access to devices which meet EU standards. The MHRA is seeking views on whether indefinite recognition should apply to all devices, or only those which are classified as either the same or in a lower risk category under the Medical Devices Regulations 2002 as they are in the EU MDR or IVDR.

If indefinite recognition for all CE marked devices is implemented, it would mean that the classification rules in the EU MDR or IVDR would be accepted in GB.

Conversely, if this is only implemented for the same or lower risk category devices, then the GB classification rules would apply and take precedence over the EU classification rules, in those cases where the device classification is higher under MDR 2002 as opposed to under the EU MDR or IVDR.

3. Introducing an international reliance route for a small proportion of CE-marked devices that would fall into a higher risk class under GB rules, to ensure appropriate oversight while maintaining access.

After 30 December 2030, manufacturers of devices which fall into a higher risk category under GB rules than in the EU and that are already CE-marked could continue to access the GB market using this international reliance route or the UKCA conformity assessment process. This expands on the July 2025 consultation response which focused on devices from comparable regulator countries in North America and Australia, by targeting EU devices where certain criteria are satisfied.

Annex B of the consultation sets out a list of pre-requisites for devices to be eligible for the international reliance route. These include having English language labelling/packaging, compliance with the post-market surveillance (PMS) requirements in the Medical Devices Regulations 2002; and be within the scope of the Medical Devices Regulations 2002. A certificate of international reliance would not provide a UKCA marking or UKCA certification, it would only grant access to the GB market.

User guidance for mental health apps

On 27 January 2026, the MHRA published user guidance for mental health apps. Developed with support from NHS England, the guidance provides advice to members of the public who use mental health apps. It aims to educate users to understand what safe and reliable mental health technology looks like, and explains the reasoning why some mental health apps may not be as reliable as others.

If an app is classified as a medical device, it is subject to MHRA regulation and approval and must meet the relevant safety standards, including confirmed CE or UKCA marking, before it can be placed on the market. Conversely, if a mental health app is categorised as a wellbeing or lifestyle product, it is not subject to the MHRA’s regulations. Although this does not necessarily mean that such apps are unsafe, the guidance makes it clear that these apps are governed by different, and less stringent, requirements than regulated mental health apps.

The guidance also encourages users to familiarise themselves with what safe digital mental health technology looks like, using accessible materials such as animated videos and real-life examples. The intention is to make key information memorable and thought-provoking, prompting users to ask questions about the tools they rely on and to discuss suitability with their clinicians where appropriate.

In addition, the guidance highlights the MHRA’s 'Yellow Card Scheme', the designated platform for reporting concerns about medicines and medical devices. While many manufactures and organisations regulated by the MHRA will already be familiar with this system, the widespread public use of unregulated mental-health technologies makes it important to raise broader awareness. Informing the public of the Yellow Card Scheme helps ensure that individuals now exposed to unregulated mental-health apps understand how to report safety issues, ultimately supporting improved oversight and user protection.

This guidance has been published at a crucial time as the government begins to implement its 10-year health strategy, which includes a key commitment to expanding the National Institute for Health and Care Excellence’s (NICE) appraisal process of medical technologies.

The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025

Separately, on 28 April 2026, The Medicines for Human Use (Clinical Trials) Amendment Regulations 2025 will come into force after a 12-month implementation period. The new framework introduced via this legislation is designed to:

• Adopt the latest Good Clinical Practice standards;

• Enhance transparency;

• Simplify consent procedures;

• Implement new pharmacovigilance rules;

• Modernise requirements for manufacturing, labelling and importation.

The regulations streamline the approval process of applications. Specifically, regulatory scrutiny (from the MHRA) and ethical reviews (from Research Ethics Committees) are to be merged into a single application, preventing duplication and in a shorter timeframe of a maximum of 30 calendar days.

A notification scheme for initial applications and modifications in the process is also to be introduced. This creates a fast-track pathway for lower-risk studies through automatic authorisation, although note that the sponsor bears the responsibility of determining if the trial meets the relevant criteria. This will allow eligible trials to become operational in a much shorter timeframe.

The changes also seek to align with international good clinical practice, specifically the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines. This ensures that UK clinical trial data can be accepted on a global basis.

The importance of transparency features strongly in the revised legislation. Sponsors will be legally obliged to register trials on a public registry before the first participant enrols or within 90 days of approval, and to publish summary results within 12 months of trial conclusion. They must also offer participants a lay summary. Non-compliance is punishable as an offence.

Additionally, the pharmacovigilance framework is being strengthened to ensure rigorous safety monitoring and clearer sponsor and investigator responsibilities. Labelling, manufacturing, and import requirements for investigational medicinal products have been updated. Archiving obligations have also been extended significantly, increasing retention of trial master files from 5 to 25 years to ensure long-term data integrity.

The MHRA’s goal is to enhance patient safety and promote participant centred trial design, while shortening the time from application to recruitment by nearly 40%, with a shift from an average of 250 to 150 days.

Sponsors should ensure they are compliant with new requirements, and keep an eye out for updated guidance that the MHRA is due to issue.

This article was co-authored by Trainees, Brooke Foster, Katy Parkinson and Fiona Broad.