Jurisdiction(s):
United Kingdom

EU and UK life sciences weekly update: medical devices, pharmaceuticals, IP, AI Act, Windsor Framework, cosmetics, plant varieties, EMA/HRA, FOI tribunal (27 February 2025)

Published on: 27 February 2025

Published by a LexisNexis Life Sciences expert

Legal News

Article summary

In this issue:

Medical devices
Pharmaceuticals—regulatory framework
Intellectual property
Borderline products
Research and development
Data protection and confidential information
Daily and weekly news alerts
Trackers
New and updated content
Useful information

Medical devices

Inside the EU’s headache to designate AI models ‘with systemic risk’

MLex: The EU AI Act imposes stringent obligations on AI models judged to carry a ‘systemic risk’. Yet fresh trends — including a novel Reinforcement Learning-centred paradigm and improved compute efficiency — are undermining the principal designation approach before the provisions even bite. Work on alternative designation benchmarks is already under way, but EU officials are likely to struggle to match a technology accelerating at a blistering pace. See News Analysis: Inside the EU’s headache to designate AI models ‘with systemic risk’.

Commission opens consultation on electronic instructions for use for certain medical devices

The European Commission has launched a feedback window on a draft implementing regulation that would permit instructions for use in digital format for all medical devices intended solely for healthcare professionals.

...

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

Using the Judicial College Guidelines to assess general damages in personal injury claims

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

Tomlin orders in England and Wales: CPR guidance on drafting, confidentiality, approval, variation, enforcement, limitation, CCA issues, court-specific requirements, sample wording and precedents

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...

Precedent: Deed of Surrender of Lease with Optional Premium, Settlement and Release, Landlord, Mortgagee and Guarantor Consents, Reimbursement and HM Land Registry Provisions (England and Wales)

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 ...

Precedent Statutory Declaration: Standard Wording under the Statutory Declarations Act 1835

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 ]...