Published on: 07 January 2025
Published by a LexisNexis Life Sciences expert
In summary, the long‑anticipated substantive regime is edging closer. The consultation to revamp the regulatory regime for medical devices post‑Brexit launched in September 2021, with the government’s detailed reply issued in June 2022 (see: LNB News 16/09/2021 90 and LNB News 27/06/2022 48). In early 2024, the MHRA set out a Roadmap detailing the milestones towards the future regulatory framework (see News Analysis: MHRA issues Roadmap towards new medical devices rules). There have been two key recent developments:
In October 2024, a new PMS Statutory Instrument (SI) was laid before Parliament, representing the first significant update to the framework since the consultation. The MHRA’s goal is to bring in ‘clearer and more robust requirements’ to strengthen patient safety and support better traceability of incidents and reporting trends. The government characterised the PMS changes as a ‘priority measure’, designed to underpin patient safety ahead of additional reforms. The SI will modify and supplement the existing PMS obligations in the UK Medical Device Regulations 2002 (UK MDR) (under powers derived from section 15(1) of the Medicines and...
When evaluating a general damages claim, the practitioner ought initially to refer to the Judicial College Guidelines (JCG)...
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...
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