Jurisdiction(s):
United Kingdom

UK medical devices regulatory reform tracker: GB and NI divergence, PMS SI, IRP, CE recognition plans, UDI shift, IVD reclassification, SaMD/AI initiatives, guidance, fees and consultations (2024–26)

Published by a LexisNexis Life Sciences expert

Practice notes

$imgtext$

This Practice Note serves as a horizon-scanning tool for monitoring how UK regulatory work advances towards a new domestic framework for medical devices. It collates legislative proposals, consultations, principal guidance, initiatives, and other regulatory and governance movements affecting devices in Great Britain (GB) (ie England, Scotland and Wales) and across the UK. For updates on device developments featuring AI or digital health (including medical software and apps), refer to Practice Note: AI in life sciences and digital health tracker—UK.

Horizon scanning overview

Following the UK’s exit from the EU, the UK’s medical device regime has moved into a major phase of reform. Through the Medicines and Medical Devices Act 2021 (MMDA 2021), ministers received delegated powers to modify the Medical Devices Regulations 2002 (UK MDR), SI 2002/618, establishing the statutory footing for a comprehensive reset of the regulatory environment. The programme aims to broadly align with internationally harmonised benchmarks and the EU’s changes under the Medical Devices Regulation (MDR), Regulation (EU) 2017/745, and the In Vitro Diagnostic Medical Devices Regulation (IVDR), Regulation (EU) 2017/746, whilst also building in flexibility to...

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

Web page updated on 22/05/2026

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 ]...