Published on: 01 July 2025
Published by a LexisNexis EU Law expert
On 19 June 2025, the Medical Device Coordination Group (MDCG) issued fresh guidance (MDCG 2025-6) on how Regulation (EU) 2017/745 (the Medical Devices Regulation, MDR), Regulation (EU) 2017/746 (the In Vitro Diagnostic Medical Devices Regulation, IVDR), and Regulation (EU) 2024/1689, the EU AI Act, interrelate. The document supplies a first set of answers to the most frequently asked questions on the joint application of the EU AI Act and the MDR/IVDR for manufacturers of AI systems used for medical purposes (MDAI). The MDCG guidance clarifies a few points:
The MDCG explains that references to ‘manufacturer’ within the meaning of the MDR/IVDR should be understood as referring to ‘provider’ in accordance with the EU AI Act...
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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