Law360, London: An ostomy care company failed on 19 February 2026 to revive a patent infringement case, after an appellate court held that a rival's drainable pouch for collecting waste in colostomy patients was missing some crucial patented elements.

EU Law analysis: Alison Dennis, partner and co-head of the international life sciences team at Taylor Wessing, looks at the addition of the EU AI Act to the regulatory framework around medical devices.

Introduction This medical devices regulatory due diligence questionnaire relates to the proposed purchase by [insert buyer name] (the Buyer) of the [entire share capital of [insert name of target company] Limited incorporated in England and Wales under number [insert company number] (the Company) OR [insert description of the business to be acquired] (the Business) as a going concern, together with certain assets used in the Business ] from [insert seller name] (the Seller) (the Proposed Acquisition). This questionnaire is designed to enable the Buyer, the Buyer’s solicitors and other professional advisors to obtain the legal information relating to the medical device’s regulatory compliance from the [Company OR Business] which the Buyer requires to assist in the valuation of the [Company OR Business] and with the negotiation of the Proposed Acquisition. Please answer every question fully. Please provide your answers in italics underneath each question and provide copies of all relevant documentation, ensuring that all answers and documents are clearly marked by reference to the appropriate paragraph of this questionnaire. We reserve the right to raise further enquiries

MLex: Manufacturers of medical devices would see compliance with the EU AI Act's high-risk regime eased under a European Commission proposal. Part of a broader update to medical-device laws, it reflects longstanding industry concerns and would lower regulatory burdens for the medical technology sector if confirmed by the European Parliament and Council of the EU.

This Practice Note serves as a reference guide to compare key provisions of the current UK regime for medical devices; the EU regime as governed by the Medical Devices Regulation (MDR), Regulation (EU) 2017/745, and the In Vitro Diagnostic Medical Device Regulation (IVDR), Regulation (EU) 2017/746; and the proposed UK changes. On 25 November 2021, the Medicines and Healthcare Products Regulatory Agency (MHRA) public consultation on proposed changes to the regulation of medical devices in the UK closed (see: LNB News 16/09/2021 90). The government’s response was published on 26 June 2022. The government confirmed its intention to proceed with the large majority of the proposals which form the basis for this Practice Note’s comparison. See News Analysis: A closer look at MHRA’s proposals on future regulation of medical devices in the UK. There have been delays in laying the new regulations as the UK consults industry and stakeholders on various aspects (for example, see: MHRA extends implementation of future Medical Devices Regulations to July 2024—LNB News 26/10/2022 35, and MHRA publishes post-Brexit

These training materials consist of template PowerPoint slides that can be used as the basis of one or more training seminars on Regulation (EU) 2017/745, the Medical Devices Regulation (MDR) and Regulation (EU) 2017/746, the In Vitro Diagnostic Medical Devices Regulation (IVDR). It is anticipated that those providing training will use these slides as a helpful starting point for their presentations and then amend them accordingly to reflect their particular circumstances. The training materials are customisable. Click the links below to download the presentation. Contents • Introduction and rationale for the reform • Key changes • Scope and classification • General safety and performance requirements • Traceability—UDI • Traceability—Registration • Transparency—EUDAMED • Person Responsible for regulatory compliance • Clinical evaluation • Post-market

These drawings have been prepared by Dr Manuel Anderson, Consultant General Physician and Fellow of the Royal Society of Arts and Gillian Lee, Medical Illustrator. Anatomy diagram This sketch is inspired by Myron's sculpture (Greek, circa 460–450 BC). The muscles have been deliberately emphasised so that they show more clearly than in the original sculpture. The drawing can also be of assistance with regard to the understanding of movements of limbs: both arms are abducted. The right arm is also extended at the shoulder, while the left arm is slightly flexed at the elbow. The fingers of the right hand are flexed over the discus. The trunk is flexed at the hips and

The examination of a person by a medical practitioner.

Negligent acts or omissions of medical professionals which cause injury and damage.

PI & Clinical Negligence analysis: Her Honour Judge Emma Kelly, sitting as a High Court judge, dismissed a claim for damages arising from the stillbirth of the claimant’s son on grounds of causation. The court had identified that the midwives charged with monitoring the claimant had breached their duty in several respects including failures to refer for obstetric review and a failure to monitor her condition overnight. When determining causation, the judge considered the extent to which the concept of ‘Claimant Benevolence’, or Keefe benevolence, could be applied, ie, whether the court could err in favour of the claimant where the defendant’s negligence had deprived her of the best evidence. The judge accepted that the concept had a role to play, but did not accept that claimant benevolence could provide a bridge to causation in the face of reasoned expert evidence to the contrary. Written by David Juckes, barrister at Hailsham Chambers.

The right to obtain disclosure Disclosure is the term given to the process where parties offer up documents in their control which are material to the issues in dispute. The fundamental purpose of disclosure is to further the overriding objective by ensuring parties to litigation are on an equal footing. The meaning of ‘documents’ is not restricted to paper or writing but extends to any form of record-keeping. This includes computer databases, microfilms used to keep records, video and audio tapes and discs. In clinical negligence claims, the most important category of document is likely to be the claimant’s medical records. They will provide the most contemporaneous record of the treatment given to a patient and will, in almost all cases, be the basis of expert opinion that will determine the outcome of the litigation. An early and objective scrutiny of medical records can save a lot of time and expense and is necessary to assess the merits, strengths and weaknesses of any proposed claim from the outset. Medical

NOTE: The United Kingdom General Data Protection Regulation, Assimilated Regulation (EU) 2016/679 (UK GDPR) is applicable under UK law from the end of the Brexit transition/implementation period. For further information on the UK GDPR, see Practice Note: Introduction to the EU GDPR and UK GDPR. SUBJECT ACCESS REQUEST (Pursuant to the UK General Data Protection Regulation and Data Protection Act 2018) I hereby make a subject access request through a third party, namely my solicitor (whose details are below). Please make available to my solicitor copies of all my medical records, whether held in paper or digital format (including all radiology). As these records should be readily accessible by reference to my personal information detailed below this is not considered to be an excessive request and the records should be capable of being provided without fee within one month. The purpose of this request is to progress a [civil personal injury claim] against another party, and the records may be used by instructed medical experts to