Powered by Lexis+®
Jurisdiction(s):
United Kingdom

UK and EU life sciences legal and regulatory highlights: AI regulation, MHRA device advice, pricing and reimbursement, EMA paediatric plans, environmental standards, antibiotics shortages, NICE consultation, ASA rulings

Published on: 11 December 2025

Published by an LexisNexis Life Sciences expert
Legal News
imgtext
Article summary

In this issue:

  • Medical devices
  • Commercialisation
  • Pharmaceuticals—regulatory framework
  • Research and development
  • Advertising of medicines
  • Daily and weekly news alerts
  • New and updated content
  • Trackers
  • Useful information

Medical devices

Digital Omnibus on AI Regulation—considerations for life sciences companies

The European Commission has unveiled its Digital Omnibus on AI Regulation Proposal, a draft law with targeted measures aimed at smoothing the practical roll-out of the EU AI Act. Hélène Boland and Fabien Roy of Hogan Lovells set out key points for life sciences companies. See News Analysis: Digital Omnibus on AI Regulation—considerations for life sciences companies.

EU countries question proposed approach for delaying AI Act’s key duties

MLex reports that plans to postpone core EU AI Act obligations face scrutiny from Member States, who caution that the Commission’s method lacks clear benchmarks, predictability and adequate participation of national regulators. Even backers of a pause voiced reservations, and others queried what ensues if compliance tools remain unavailable despite the revised schedule, or if amendments fail to be adopted before the August 2026 cut-off. See: EU countries question proposed approach for delaying AI Act’s key duties.

MHRA publishes guidance on regulatory advice meetings for medical devices

The Medicines...

To view the latest version of this document and thousands of others like it, sign-in with LexisNexis or register for a free trial.

Popular documents

When evaluating a general damages claim, the practitioner ought initially to refer to the Judicial College Guidelines (JCG)...

Read More Right Arrow

This Practice Note This Practice Note reviews mechanisms used in settling litigation. A Tomlin order consists of a consent order paired with a schedule. It operates to stay proceedings on terms that have been agreed. The provisions contained in the schedule may remain confidential. This Practice Note describes the scope of confidentiality attaching to the schedule and sets out how it differs from a standard consent order. Sample wording for a Tomlin order is included, alongside links to precedents, as well as guidance on court approval. It also addresses varying, setting aside and enforcing a Tomlin order, including the considerations the court will take into account when handling applications for each. Further guidance is provided on interpreting and applying the relevant provisions of the CPR; however, some courts and divisions impose very specific requirements for both drafting and approval, and for approaching the schedule and confidentiality issues. Accordingly, you must consider the particular rules and court guide provisions in the forum where your claim is proceeding when drawing up the Tomlin order...

Read More Right Arrow

Date [ date ] Parties [ name of Landlord ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Landlord) [ name of Tenant ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Tenant) [ [ name of Guarantor ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Guarantor) ] [ [ name of Mortgagee ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Mortgagee) ] Definitions Within this Deed, the terms below shall be interpreted as follows: [ Annual Rent • the annual sum reserved under the Lease; ] [ Insurance Rent • the Tenant’s share of the Landlord’s costs of insuring the Property (as set out in the Lease); ] Lease • the lease of the Property dated [ date ], entered into between (1) [ the Landlord OR [ name ...

Read More Right Arrow

I, [ name ], of [ address ], solemnly and sincerely state that: [ Matters to be verified, set out in numbered paragraphs ] I make this solemn statement in good conscience, believing it to be true, and pursuant to the provisions of the Statutory Declarations Act 1835. DECLARED at [ details ] this [ day ] day of [ month and year ] Before me ................................................................................ [ signature of the person before whom the declaration is made ] A [ commissioner for oaths OR [ solicitor OR [ insert other qualification ] ] authorised to administer oaths ]...

Read More Right Arrow