Trackers

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Trackers

Trackers monitor key cases, legislation, consultations, guidance documents, reports, opinions and other events for certain areas of law. See:

  1. •

    Life sciences cases tracker—UK is intended to be used to track the progress of UK cases relevant to the life sciences sector

  2. •

    Life sciences cases tracker—EU is intended to be used to track the progress of EU cases relevant to the life sciences sector

  3. •

    Life sciences tracker—UK is intended to be used to track the progress of UK legislative proposals and current consultations relevant to the life sciences sector

  4. •

    Life sciences tracker—EU is intended to be used to track the progress of EU legislative proposals and current consultations relevant to the life sciences sector

  5. •

    Patents tracker—UK is intended to be used to track the progress of key patent judgments, legislative proposals and consultations in the UK

  6. •

    Patents tracker—EU is intended to be used to track the progress of key patent judgments, legislative proposals

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Latest Life Sciences News

AIB and MDCG issue joint guidance on Medical Devices and EU AI Act requirements

The Artificial Intelligence Board (AIB) and Medical Device Coordination Group (MDCG) have published joint guidance (AIB 2025-1/MDCG 2025-6) clarifying the interaction between Regulation (EU) 2017/745 (Medical Devices Regulation (MDR)), Regulation (EU) 2017/746 (In vitro Diagnostic Medical Devices Regulation (IVDR)) and EU Artificial Intelligence Act (EU AI Act). The guidance establishes classification criteria for high-risk Medical Device Artificial Intelligence (MDAI), conformity assessment procedures, and requirements for data governance, human oversight and transparency. It outlines when MDAI systems require third-party conformity assessment and details post-market monitoring obligations. The document also clarifies substantial modification requirements and implementation timelines, with key provisions taking effect from 2 August 2027.

Changes to NDAs under the Victims and Prisoners Act 2024

Information Law analysis: The Victims and Prisoners Act 2024 (VPA 2024), section 17 comes into effect on 1 October 2025. The provision codifies common law protections for the reporting of crime to the police and whistleblowing in relation to criminal activity. It also expands the liberty of victims of crime to make certain further disclosures without risk of enforcement of non-disclosure agreements (NDAs). The scope of permitted disclosures includes those made for the purposes of seeking legal advice, co-operating with regulatory investigations and seeking support from certain persons in relation to the relevant conduct, which include, among others, victim support services, and the close family of the person making the disclosure. From 1 October 2025, contract terms seeking to prevent the making of such disclosures will be void and unenforceable. Written by Gaelyn Fuhrmann, solicitor at Wiggin.

DSIT welcomes DUA Bill becoming Act of Parliament as DUAA

The Department for Science, Innovation and Technology (DSIT) has welcomed the Data (Use and Access) Bill (DUA Bill) receiving Royal Assent on 19 June 2025 and becoming law as the Data (Use and Access) Act 2025 (DUAA). DSIT notes that key measures include enabling real-time sharing of healthcare data across NHS services, saving 140,000 hours of admin annually and improving patient care, and the simplification of digital identity verification through certified tools, aiding tasks like renting or job application. The DUAA also introduces legislation to support investigations into child deaths linked to social media by preserving relevant data. Additionally, DSIT underlines that as mandated by the DUAA, a new Information Commission will replace the ICO, with a recruitment drive underway for its board to ensure diverse expertise.

MDCG Guidance on Performance Studies for In Vitro Diagnostic Medical Devices

The Medical Device Coordination Group (MDCG) has issued a comprehensive guidance document, endorsed in June 2025, addressing performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746. The document, developed by representatives from all Member States and chaired by a representative of the European Commission, delineates the applicable regulatory framework and procedures. It clarifies the definitions and distinctions between analytical and clinical performance studies, stipulates when a device is deemed an in vitro diagnostic medical device (IVD) and consequently subject to the Regulation, and sets out responsibilities regarding the assignment of intended purpose and conduct of performance studies. The guidance details the requirements for application or notification to competent authorities, including specific scenarios such as studies involving surgically invasive sample-taking, companion diagnostics, and left-over samples, alongside the relevant articles of the Regulation. It further provides practical instructions on documentation, submission requirements, safety reporting, and the handling of substantial modifications. The document serves as a harmonised reference for sponsors of performance studies, clinical investigators, and manufacturers, ensuring compliance with the IVDR, while underscoring the importance of adhering to both European and national legislative requirements in the conduct of performance studies.

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