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

This digest covers key virtual and digital health regulatory and public policy developments during May and early June 2024 from United Kingdom, and European Union.

Of interest, artificial intelligence (AI) safety has been in focus over the past month, including with the publication of the Interim International Scientific Report on the Safety of Advanced AI. International collaboration in this area is increasing as world leaders met at the AI Summit in Seoul, and the UK government recently announced a collaboration on AI safety with Canada, supplementing its existing commitment with France. Further, the UK launched the AI safety evaluations platform, which is available to the global community. In the meantime, the EU has established an AI Office to oversee the implementation of the AI Act and the Medicines and Healthcare products Regulatory Agency (MHRA) has published its AI Airlock to address novel challenges in the regulation of artificial intelligence medical devices (AIaMD).Continue Reading Virtual and Digital Health Digest – June 2024

On 2 February 2024, the US Food and Drug Administration (FDA) published its much anticipated final rule amending the medical device Quality System Regulation, which sets out the FDA’s quality management system (QMS) requirements for medical devices. The amendments seek to align more closely with International Standard Organization (ISO) standard 13485:2016, Medical Devices —

On 23 January 2024, the European Commission announced proposals to amend the Medical Device Regulations (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Device Regulations (EU) 2017/746 (IVDR), as applicable, to:

  • extend the transition provisions for certain in vitro diagnostic medical devices (IVDs) under the IVDR
  • allow for a gradual roll-out of Eudamed so that certain modules will be mandatory from late 2025
  • include a notification obligation in case of interruption of supply

The proposal will now need to be adopted by the European Parliament and Council before it enters into force. However, as the proposal follows a similar structure to the recent amendments to the MDR, we do not anticipate significant changes during the legislative process.Continue Reading Commission proposes extension to IVDR transition periods and accelerated launch of Eudamed