On 6 February 2025, EU Member States announced the launch of a new pilot scheme for coordinated assessment of clinical investigations of medical devices (CI) and performance studies for in vitro diagnostic (IVD) medical devices (PS). Supported by the European Commission, the pilot allows sponsors to submit a single CI or PS application for review across multiple Member States, rather than each Member State conducting independent standalone reviews. The pilot scheme aims to make the application process for multi-national CI and PS more efficient and to reduce the duplication of activities by both the sponsor and competent authorities. As this has been a major cause of delays and complications in conducting CIs, this pilot will be welcomed by industry.
Continue Reading EU announces pilot coordinated assessment for clinical investigations of medical devicesMedical Devices
Virtual and Digital Health Digest – February 2025
Welcome to the latest installment of Arnold & Porter’s Virtual and Digital Health Digest. This digest covers key virtual and digital health regulatory and public policy developments during January and early February 2025 from the United States, United Kingdom, and European Union.
In this issue, we discuss some useful international guidance documents from the International Medical Device Regulators Forum (IMDRF). These include Guiding Principles on Good Machine Learning Practices (GMLP) that build on the principles previously set out by the U.S. Food and Drug Administration (FDA), UK Medicines and Healthcare products Regulatory Agency (MHRA), and Health Canada, and guidance on characterization and risks of medical device software. The continued development of international guidance in this area highlights the importance of coordination between regulatory authorities and standardized guidance for these products. There have also been important developments in ongoing litigation relating to digital technologies, although whether these developments provide clear guidance to manufacturers remains to be seen.
Continue Reading Virtual and Digital Health Digest – February 2025Virtual and Digital Health Digest – January 2025
By Arnold & Porter, Dr Beatriz San Martin, Sofia Holmquist, Ana Gonzalez-Lamuno, Zahrah Kazim & Joy Wee on
Welcome to the latest installment of Arnold & Porter’s Virtual and Digital Health Digest. This digest covers key virtual and digital health regulatory and public policy developments during December 2024 and early January 2025 from the United Kingdom, and European Union.
In this issue, we feature the emerging trends in digital health in 2024 that have been highlighted in IQVIA’s recent report. The IQIVA report is a yearly summary of digital health trends and gives a good snapshot of the market. The latest report notes that Germany continues to lead in its approval and reimbursement of digital therapeutics, followed by the United States and UK.
Continue Reading Virtual and Digital Health Digest – January 2025Virtual and Digital Health Digest – December 2024
By Arnold & Porter, Dr Beatriz San Martin, Sofia Holmquist, Ana Gonzalez-Lamuno, Zahrah Kazim & Joy Wee on
Welcome to the last 2024 installment of Arnold & Porter’s Virtual and Digital Health Digest! This digest covers key virtual and digital health regulatory and public policy developments during November and early December 2024 from the United Kingdom and European Union.
Of note, health authorities in the EU continue to develop methods to assess and recommend health apps. The latest is in Denmark, where new guidance has been published on how health apps will be assessed by the Board for Health Apps. The assessment criteria includes evidence of clinical effectiveness, usability, price, and value to society. This guidance is another important step to ensure greater access to health apps across the EU.
It has been a busy year in digital health and the impact to care delivery is only just beginning. We hope you will continue to follow the digest in 2025 as we track what we expect to be an even busier year.
Wishing you the best for the new year!
The Arnold & Porter Team
The European Commission launches public consultation on the MDR and IVDR
By Arnold & Porter & Eftychia Sideri on
The European Commission has opened the floor for a discussion on whether the EU medical devices legislation is effective, efficient, relevant, coherent and valuable.
The Commission aims to assess the performance of the Medical Devices Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR). Anyone interested in giving feedback to the Commission must do so by 21 March 2025 using this link.
The results of this consultation may not provide any quick or easy solutions to the difficulties that have been encountered as a result of the MDR and IVDR. However, it is an opportunity for the European Commission, and later the EU legislators, to reconsider objectives, understand the needs and difficulties of the industry and set realistic targets for all stakeholders.
Continue Reading The European Commission launches public consultation on the MDR and IVDRFDA LDT Final Rule Litigation — Status and What May Happen Next
By Mahnu Davar & Philip Desjardins on
In our blog post from May this year, we set out what you need to know about the U.S. Food and Drug Administration (FDA) final rule, revising the regulatory definition of an in vitro diagnostic (IVD) to explicitly capture IVDs manufactured by laboratories (known as laboratory developed tests or LDTs).
Following that publication, two…
Medical devices: European Commission issues Q&A on the obligation to notify supply interruptions and discontinuations
The European Commission (‘Commission’) has published a Questions & Answers (‘Q&A’*) document on the new obligation to notify interruptions or discontinuations of the supply of medical devices under the Medical Devices Regulation (Regulation (EU) 2017/745, ‘MDR’) and the In Vitro Diagnostic Medical Devices Regulation (Regulation (EU) 2017/746, ‘IVDR’).
This new reporting obligation is set out in the newly introduced Articles 10a in both the IVDR and the MDR, as amended by Regulation (EU) 2024/1860. This obligation will start to apply on 10 January 2025.
Our blog focuses on the key requirements applying to manufacturers, and how these align with the European Medicines Agency’s (‘EMA’) role to monitor medical device shortages.
Continue Reading Medical devices: European Commission issues Q&A on the obligation to notify supply interruptions and discontinuationsVirtual and Digital Health Digest – November 2024
By Arnold & Porter, Sofia Holmquist, Ana Gonzalez-Lamuno & Mimi Simmons on
This digest covers key virtual and digital health regulatory and public policy developments during October and early November 2024 from the United Kingdom and European Union.
Regulatory and legislative reform is on the horizon in both the UK and in the EU, which will impact software and artificial intelligence (AI) medical devices. The UK government recently published the new medical devices post-market surveillance rules, which could be in place by summer 2025. Further, the Medicines and Healthcare products Regulatory Agency’s (MHRA) priorities until spring 2025 are focused on the draft pre-market rules for devices, the in vitro diagnostics (IVD) roadmap, and guidance on AI development and deployment. In the EU, industry should watch the potential upcoming reform of the Medical Devices and In-Vitro Medical Devices Regulations, with increasingly urgent calls for reform from key stakeholders gaining traction with the institutions.
Continue Reading Virtual and Digital Health Digest – November 2024EU looks to facilitate development of “orphan” medical devices
By Arnold & Porter & Christopher Bates on
The European Union has for the first time introduced measures to facilitate the development of medical devices for rare conditions, and has recently published the Medical Devices Coordination Guidance on the clinical evaluation of orphan devices (the MDCG Guidance). Key aspects of the document include defining “orphan devices” and guidance on their clinical evaluation, including when it may be justified to certify a product with limitations in the pre-market clinical data.
The MDCG Guidance also envisages further assistance to manufacturers of orphan devices and their Notified Bodies through the provision of scientific advice by expert panels. To help implement the new guidance, the European Medicines Agency (EMA) is operating a pilot programme to provide scientific advice for manufacturers of orphan devices. The pilot programme is intended to operate until the end of this year, with the intention that scientific advice from expert panels will subsequently be rolled out on a wider basis.
Continue Reading EU looks to facilitate development of “orphan” medical devicesUK Government Publishes Draft Regulations on Medical Devices Post-Market Surveillance
By Arnold & Porter, Christopher Bates & Mimi Simmons on
On 21 October 2024, the UK Government laid before Parliament the draft statutory instrument setting out proposed new post-market surveillance (PMS) requirements for medical devices in Great Britain (the PMS SI). The PMS SI will significantly enhance the PMS requirements for manufacturers of medical devices placed on the market or put into service in Great Britain.
PMS comprises the post-market monitoring and evaluation of the safety and performance of a medical device. Currently, the medical devices legislation applicable in Great Britain contains limited, high-level requirements for a device manufacturer to operate a PMS system as part of its Quality Management System (QMS). Much of the detail on how a manufacturer should operate its PMS system, including incident reporting, is set out in guidance, primarily EU MedDev guidance 2.12/1 rev 8 and related guidance published under the old EU Directives (upon which the Great Britain medical devices regulatory framework is based). The PMS SI will introduce much more detailed obligations into UK legislation, with a view to creating greater consistency and making enforcement easier. The amendments contained in the PMS SI will bring PMS requirements in Great Britain broadly into alignment with those in the EU Medical Device Directive 2017/745 (the MDR) and the EU In Vitro Diagnostic Medical Devices Directive 2017/746 (the IVDR) (which apply in Northern Ireland).
Notably, the new PMS requirements will apply to all medical devices placed on the market in Great Britain (subject to limited exceptions), including devices CE marked under the EU regimes and made available in Great Britain under transitional arrangements.
Continue Reading UK Government Publishes Draft Regulations on Medical Devices Post-Market Surveillance