Weekly highlights

Weekly highlights

Each week we provide a round-up of key legal developments in the life sciences sector curated by our life sciences legal team. This includes

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Latest Life Sciences News

MHRA launches call for evidence on the regulation of artificial intelligence in healthcare

The Medicines and Healthcare (MHRA) products Regulatory Agency has launched an open call for evidence to inform the work of the National Commission into the Regulation of AI in Healthcare, seeking views on how artificial intelligence used in healthcare should be regulated in the UK. The MHRA established the Commission to advise on the development of a regulatory framework for AI as a medical device that is safe, effective, proportionate and trusted, with recommendations to be published in 2026. It seeks views on whether the current regulatory framework is sufficient, how it may need to be improved to support timely access to safe and effective AI medical devices, how safety and performance should be monitored once such technologies are in use, and how responsibility and liability should be allocated across those involved in their development and deployment, in order to address emerging regulatory challenges while supporting innovation and maintaining public trust . The call for evidence will run until 2 February 2026.

MHRA updates guidance on Health Institution Exemption for medical devices

The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on the Health Institution Exemption (HIE) for general medical devices in Great Britain. The exemption allows health institutions, such as NHS Trusts and Boards to design, manufacture or modify devices for in-house use only, subject to safety and quality requirements. Key changes include clearer definitions, practical examples and five principles of good practice: (1) quality management; (2) ensuring device traceability; (3) meeting essential requirements; (4) keeping technical documentation; and (5) post-market monitoring. The exemption applies only to general medical devices and does not cover in vitro diagnostic devices (IVDs). Institutions should inform patients when devices are made under the exemption and report safety issues via the Yellow Card scheme. The update replaces previous in-house manufacturing guidance. Separate EU-aligned rules apply in Northern Ireland.

Medical devices to get softer AI compliance regime, European Commission proposes

MLex: Manufacturers of medical devices would see compliance with the EU AI Act's high-risk regime eased under a European Commission proposal. Part of a broader update to medical-device laws, it reflects longstanding industry concerns and would lower regulatory burdens for the medical technology sector if confirmed by the European Parliament and Council of the EU.

ASA issues final guidance on less healthy food and drink advertising restrictions

TMT analysis: From the 5 January 2026, ads for ‘identifiable’ less healthy food and drink products will be banned from appearing on television between 5.30 am and 9.00 pm, on on-demand programme services between 5.30 am and 9.00 pm, and in paid online media at any time. Alongside exemptions for SME’s and media outside scope (such as radio, press and posters), the regime creates a safe harbour for ‘brand advertisements’. Brinsley Dresden, Rebecca Moore, and Helen Hart of Lewis Silkin consider the issues.