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The current EU regulatory landscape for biotechnology is widely viewed as insufficient to be able to exploit the full potential of such technologies. Regulatory hurdles exist at EU and Member State level, and this is thought to have driven investment into other regions.

To help tackle this problem, the introduction of a new EU Biotech Act (the Act) has been proposed by the Commission to encourage innovation in areas such as health technology assessment and clinical trials. A simpler regulatory landscape, with no reduction to safety standards, will be a central aim of the Act.

However, it was announced on 20 March 2025 that the Act has been delayed until the third quarter of 2026 (initially due in the last quarter of 2025). As such, it remains to be seen what shape the Act will take, including whether any changes will be limited to setting out general guidelines, or whether it will take the form of a binding legal instrument, imposing specific measures to which Member States and EU institutions must adhere. Various studies and papers have been developed following the announcement of the proposed Act, and it is hoped that as these are finalised, they will provide further insight into what we can expect.Continue Reading EU Biotech Act– what we know so far

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 11 March 2025, the European Commission published a proposal for a Critical Medicines Act (CMA).

The CMA introduces measures to improve the security of supply chains and availability of critical medicinal products and medicinal products of common interest in the European Union (EU). Some of the proposed measures directly affect Life Sciences companies, while other measures targeting the EU Member States can have a significant indirect impact on Life Sciences companies.Continue Reading European Commission Publishes Proposal for EU Critical Medicines Act

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

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 2024

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

On 24 April 2024, the European Parliament formally adopted the Regulation on Standards of quality and safety for Substances of Human Origin (SoHo) intended for human application (the SoHO Regulation). On the same date, the European Commission published a Questions & Answers (Q&A) document on the SoHO Regulation. Then on 27 May 2024, the EU Council adopted the new rules. For the final step in the legislative process, the new Regulation is due to be published in the Official Journal shortly.

The SoHO Regulation aims to introduce new and innovative measures to help ensure that high standards of safety and quality for SoHO are maintained across the EU and that SoHO activities are appropriately regulated.  A key goal is to facilitate cross-border exchanges and access to SoHOs across the EU, while ensuring high levels of health for donors, recipients and offspring from medically assisted reproduction. A more harmonised approach to the regulation of SoHO across the EU is envisaged, which will be welcomed by industry. However, Member States may still diverge and include more stringent measures under their national laws. The extent to which one Member State’s authorisation of a SoHO Entity, SoHO establishment or SoHO preparation is really “EU wide” therefore remains to be seen. Furthermore, the success of the SoHO Regulation is reliant upon cooperation and coordination between Member States, including the use of the SoHO Platform and seeking opinions from the SoHO Coordination Board on borderline issues. This will require continuous contact between Member States and a good understanding of the ever-developing and innovative uses of SoHOs. Guidance accompanying the new rules, as well as what measures need to be put in place from the outset, will need to be informative, clear and proportionate for the SoHO Regulation to make the differences it is intended to achieve.Continue Reading European Parliament adopts Regulation on substances of human origin (SoHO)

On 20 March, the Commission proposed several measures intending to boost technology and biomanufacturing in the EU, including the Commission Communication Building the future with nature: Boosting Biotechnology and Biomanufacturing in the EU; and Questions & Answers on the Commission Communication.

The Communication, while directed towards the broader biotech sector, refers to the aim to have a resilient EU biotech ecosystem to safeguard the supply of innovative and generic medicines. It recognizes the significance of vaccine and mRNA technology research for cancer, cardiovascular infectious, and rare diseases, as well as the role of AI in personalized healthcare and diagnostics, including generative AI for medicines discovery and complex genetic diseases.

At the same time, it acknowledges the challenges found in the biotech sector in the EU due to complex regulatory obstacles both nationally and at EU level; or the uncertainty over the return of their investments. Continue Reading Commission Communication on biotechnology and biomanufacturing

On 11 March, the European Commission adopted the proposal for a Delegated Regulation to amend Regulation (EC) No 1234/2008 as regards the examination of variations to the terms of marketing authorisations for medicinal products for human use: Commission Delegated Regulation (EU) 2024/1701 of 11 March 2024. The amendments will apply from 1 January 2025.

Scientific and technological advancements have led to a rise in the number of requests for variations to marketing authorisations (MA) and have brought the need to revise the variations procedure to make it more efficient and adaptable to change, in particular in relation to biological medicinal products, vaccines and medical devices.

The proposal aims to make the variations procedure simpler, clearer and more flexible to be able to respond to scientific and technological progress, and to reduce administrative burden.Continue Reading European Commission proposal to amend the Variation Regulation for Medicines