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We recently published this Advisory for our US clients, but thought it may be a useful reminder for UK and EU teams given the number of updates in this area.

We are sure that you are aware that the European Union (EU) medical devices framework has been subject to significant changes over recent years. However, implementation of the new rules has been problematic since the beginning, as both the industry and the EU institutions, national authorities, and notified bodies have found it difficult to adapt to the stricter and demanding new legal requirements. There are ongoing delays in companies obtaining CE marks under the new regime, criticism that the rules are stifling innovation, and concerns about the impact on patients.

Given the calls for change, criticism, and ongoing consultations, this Advisory sets out the current status of developments and what is important to know when seeking to do business in the EU.Continue Reading EU Medical Devices Legislation: What You Need To Know Given Latest Developments and Ongoing Challenges

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 devices

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 IVDR

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 discontinuations

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 devices

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

On 23 October 2024, the European Parliament adopted a resolution on the urgent need to revise the Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR).

This resolution acknowledges that the MDR and IVDR were adopted to strengthen the regulatory framework for medical devices and in vitro diagnostic medical devices in the EU, to ensure higher standards of safety, transparency and clinical performance, while also fostering innovation in the sector. However, it is also acknowledges that significant challenges have been encountered in implementing the MDR and the IVDR. These include delays, shortages, and difficulties in navigating the regulatory procedures. The particular impact on small and medium sized enterprises (SME) and on patient care are highlighted.

The lack of harmonised procedures for Notified Bodies, and the lack of harmonised interpretation of the MDR and IVDR between Notified Bodies, is also noted, and the fact that this leads to unpredictable timelines for certification and market access.

The Parliament resolution therefore seeks to address some of these difficulties. Continue Reading European Parliament resolution on need to revise the Medical Devices Regulation

In our recent blog post, we reviewed the overall impact of the new EU AI Act on the life sciences industry. The AI Act (Regulation (EU) 2024/1689), which entered into force on 1 August 2024, is the world’s first comprehensive law regulating artificial intelligence (AI). While some provisions are already applicable, the provisions relating to high risk AI systems, which are those most likely to impact the life sciences industry, will apply from 2 August 2027.Continue Reading The European AI office and other resources relevant to high risk AI systems

In our previous blog post, we set out the Commission’s proposed amendments to the Medical Devices Regulations (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulations (EU) 2017/746 (IVDR). The new Regulation introducing these changes has now been published: Regulation (EU) 2024/1860.

The new Regulation includes a welcome extension to the transitional periods for certain IVDs under the IVDR, where applicable conditions have been met. The other proposals relate to a gradual roll-out of Eudamed and notification obligations for interruptions in supply.Continue Reading Transition periods under the IVDR extended