Published on: 09 January 2025
Published by a LexisNexis Life Sciences expert
The UK Medicines and Healthcare products Regulatory Agency’s (MHRA) post-Brexit overhaul of the medical devices regime is solidifying, marked by new Post Market Surveillance (PMS) regulations laid before Parliament in October 2024 and an additional government consultation focused on selected aspects of the forthcoming core rules. 2025 is set to be decisive, with the cornerstone draft ‘core’ legislation expected. By Harriet Hanks, counsel, Andrew Austin, partner, Emily Bloxsome and Honor May, associates, and Charlotte Case, trainee, Freshfields LLP. See News Analysis: UK medical devices regulatory reform—where are we now and what’s next for 2025?
The Medical Device Coordination Group (MDCG) has issued two refreshed documents delivering updated guidance for the medical device sector. See: LNB News 08/01/2025 20.
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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...
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 ...
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