Life sciences - market insights April 2025

This article was co-authored by Trainee Solicitor Eleanor Sinnerton.

AI Airlock

The pilot phase of the AI Airlock runs until April 2025. Five technologies have been selected for this pilot including AI to improve cancer care and medical devices for respiratory diseases patients. At the end of the pilot phase, reports will be produced that will inform regulation and guidance for AIaMD products.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) launched its first regulatory sandbox ‘AI Airlock’ on 9 May 2024, enabling manufacturers to explore how best to collect evidence that might later support their products’ regulatory approvals.

The AI Airlock provides a safe space to trial new AI as Medical Device (AIaMD) products under MHRA supervision, to understand regulatory challenges associated with AIaMDs, mitigate any risks identified, facilitate innovation, and a bespoke regulatory framework to protect patient safety.

MHRA Roadmap for medical devices

The MHRA’s Roadmap, which sets out the timeline for the UK’s new future regulatory framework, was updated on 11 December 2024. The new Roadmap outlines the key dates for 2025 in relation to the milestones for the following:

• PMS (post-market surveillance) regulations
• New regulations for pre-market requirements
• IVD (in vitro diagnostics) roadmap
• Key dates for deployment of software/cybersecurity.

New post-market surveillance requirements for medical devices

The Post-Market Surveillance (PMS) Statutory Instrument (SI) (UK PMS Regulation) will come into force on 16 June 2025 representing an important step towards updating the framework for medical device regulation in Great Britain.

The MHRA reports that the new PMS measures aim to prioritise patient safety. The measures are expected to reduce adverse incidents by ensuring manufacturers identify and address issues earlier and reduce the time for corrective actions to be taken. The new PMS measures also aim to bring the UK’s existing medical device regulatory framework more in line with the EU’s Medical Device Regulation and In Vitro Diagnostic Medical Device Regulation.

The MHRA published guidance which sets out comprehensive changes introduced by the UK PMS Regulation, establishing stricter monitoring requirements, clearer reporting timelines and more detailed documentation requirements for manufacturers to ensure device safety and regulatory compliance throughout the device life cycle.

Consultation on medical Device regulations: Routes to market and in vitro diagnostic devices

The MHRA hosted a consultation from 14 November 2024 to 5 January 2025, for feedback on the proposed changes to the regulatory framework for medical devices. The consultation was open to the likes of patients, medical device researchers, manufacturers, clinicians and other healthcare professionals.

MHRA proposals set out in the consultation focused on four key areas:

• International reliance – continued support for the introduction of expedited routes to market for certain medical devices which already have regulatory approval in comparable regulator countries, such as the EU and US.
• UKCA marking – physical UKCA mark requirements to be replaced with unique device identification requirements, including unique device identifiers assigned to devices for traceability.
• In vitro diagnostic devices (IVDs) – replacement of the current classification scheme governing IVD regulation, with a scheme more closely aligned with the EU and other international requirements.
• Assimilated EU law – removal of the revocation date of 26 May 2025 for four assimilated EU laws, to avoid disruption to the regulatory framework and patient safety. Dismissal of these revocation dates will mean the assimilated laws will apply until they are transposed with updated UK legislation.

The Government response, published on 26 February 2025, states the response to proposals was “overwhelmingly positive”. In addition, it provides that careful analysis is to be given to the responses to the assimilated EU law proposal, following which and once Parliamentary allows, secondary legislation will be drafted and made.

Innovative Licensing and Access Pathway (ILAP)

The UK Government relaunched ILAP for medicinal products at the end of January 2025. ILAP, first launched in 2021, is an initiative to accelerate entry to market for innovative medicinal products, facilitating patient access. The re-launch will create a single integrated platform for collaboration between the developer, the MHRA, the UK Health Technology Assessment bodies and the NHS as a new core partner of the initiative.

The new ILAP began accepting applications for medicinal products to partake in this initiative from 31 March 2025. The application guidance provides that the focus will be on therapeutic medicinal products with evidence of safe use in humans, but where confirmatory trials have not yet started.

In-house manufacture of medical devices

In-house manufactured medical devices are devices that are both manufactured and used for patients in the same healthcare establishment, such as an NHS hospital. Guidance outlining the minimum requirements healthcare institutions must satisfy when manufacturing medical devices in-house is currently under review by the MHRA.

The guidance will not apply to devices manufactured for independent dental practices and separate guidance will apply for in-house manufactured in-vitro diagnostic medical devices.

New MHRA guidance on digital mental health technologies

On 3 February 2025, the MHRA published new guidance on the regulatory qualification and classification of digital mental health technologies (DMHTs). The guidance will help manufacturers identify whether their DHMT qualifies as a ‘software as a medical device (SaMD) product’. According to the guidance, a DHMT will be classified as a SaMD if the intention is for it to have a medical purpose and it is considered to have ‘high functionality’. If a DMHT qualifies as a medical device, it will be subject to classification rules that determine its regulation.

Status of the Terminally Ill Adults (End of Life) Bill

The Terminally Ill Adults (End of Life) Bill was introduced by the House of Commons. The Bill proposes, subject to safeguards and protections, to allow terminally ill adults to receive assistance to end their own life.

The Bill passed its second reading in the House of Commons on 29 November 2024 and is now under consideration by a Public Bill Committee. The Bill is likely to remain in the House of Commons Committee Stage until this April.

Read more about the Terminally Ill Adults Bill in our healthcare market insights.