The Growing PFAS Focus in Europe and the UK – Strategies for Life Sciences Companies
PFAS, or per- and polyfluoroalkyl substances – which are widely used across industries and in life sciences applications, from cosmetics and food-contact-material to medical devices and pharmaceuticals – have become an increasing focus of regulatory scrutiny across Europe. In the EU, broad legislative measures aim at restricting the manufacture, placing on the market, and use of PFAS across a wide range of industries, resulting in industry and policy consequences. In contrast, the United Kingdom is considering more targeted regulatory approaches, signaling a potential divergence from the EU framework. The life sciences sector is particularly affected by these developments, given its historic reliance on PFAS in discovery, development, manufacturing, packaging, delivery, and safe use of medicines and healthcare products. These substances are often used for safety and performance reasons, e.g., in diagnostic assays and implantable medical devices, and play a key role in many pharmaceutical manufacturing processes. While carve-outs are likely to apply for certain uses, a broad legislative measure will undoubtfully have sweeping consequences for the life sciences industry. This blog post examines the evolving European regulatory landscape and considers the implications of forthcoming PFAS restrictions for businesses operating in the life sciences sector in Europe.
A More Competitive MedTech Landscape in the EU? What the MDR/IVDR Revision Could Mean for MedTech Manufacturers and Investors
The EU’s targeted revision of the medical device and in vitro diagnostics framework has entered a more active phase, with nearly 800 amendments tabled in Parliament in July 2026 and the Council’s examination continuing in parallel. The revision would ease certification bottlenecks by removing the five-year cap on certificate validity, scaling notified body involvement to device risk, and letting lower-risk software move down to self-certified Class I. It would also loosen clinical evidence requirements, create fast-track pathways for orphan and breakthrough devices, and regulate AI-enabled devices primarily under the MDR/IVDR rather than the AI Act. This post summarizes the key aspects of the proposed revision, the prospects for their adoption, the issues still in play, and what manufacturers and investors should plan for.
EU Biotech Act I: Parliament and Council back Europe’s biotech competitiveness agenda – SPC incentive now the key battleground
Momentum is building behind the European Biotech Act I. The European Parliament and the Council of the EU broadly back the competitiveness agenda, with strong cross-party support for faster clinical trials, strategic-project funding, and regulatory simplification, and Member States showing less resistance than expected. The supplementary protection certificate (SPC) extension is the main open point – and the clearest test of how far Europe will go to attract biotechnology research, development, manufacturing, and investment.
The Commission presented its proposal in December 2025 (see our initial Sidley blog post here). This update focuses on how the package has evolved since then and what the latest developments in Parliament and the Council mean for biopharmaceutical developers and investors.
Is my product a medical device? EU Court judgment clarifies that the test includes objective function and intended purpose, and provides guidance relevant to software and AI-enabled tools
The recent judgment of the Court of Justice of the European Union (CJEU or the Court) in Case C-427/24, Diagramm Halbach clarifies the key principles for determining whether a product falls within the definition of a medical device and will be subject to the EU medical device regime. Crucially, the CJEU held that this analysis includes an assessment of both the manufacturer’s intended purpose of the product and whether the product objectively performs functions for a specific medical purpose listed in Article 2(1) of Regulation (EU) 2017/745, the Medical Devices Regulation (MDR).
UK Looks To Modernize Medicines And Medical Device Regulation In The Era Of AI
A landmark program designed to deepen the regulatory partnership between the UK and the U.S., a regulatory ‘sandbox’ for AI as a medical device, evidence-gathering on AI regulation in healthcare, a consultation on a draft Rare Disease Therapies Regulatory Framework and the launch of the largest package of UK clinical trial reforms in over 20 years – Sidley’s Dr. Chris Boyle and Zina Chatzidimitriadou bring you up to date with developments at the UK Medicines and Healthcare products Regulatory Agency (MHRA) in the first half of 2026.
The EU AI Act’s Machinery Exemption: Does It Extend to Surgical Robotics?
The EU’s latest AI reforms are intended to reduce regulatory duplication for products already subject to extensive sector-specific regulation. For manufacturers of surgical robotics, however, they leave unresolved how AI embedded within increasingly sophisticated surgical systems will be regulated in practice.
EU Pharma Package: Compromise Text Published – Best Efforts Required (Part 2)
After a 10-year process, the compromise text of the new EU General Pharmaceutical Legislation (GPL or Pharma Package) has been published and will soon become law. This blog post discusses the 10 most important changes for company pipelines, transition mechanisms, interaction with other laws, and next steps, and concludes that best efforts will be required from all stakeholders, including Member States, to make the new provisions work and create an attractive environment for medicinal products in the EU – including the interaction between with the Critical Medicines Act (compromise text adopted on 12 May 2026) and the Biotech Act (which is in progress).
Navigating the European Health Data Space Regulation: An (Uneasy) Marriage Between EHDS and GDPR (Part 2)
The European Health Data Space Regulation (EHDS Regulation) took effect on March 26, 2025. Most of its secondary use provisions will apply from March 2029, and implementation at EU and Member State level will have to take place between 2027 and 2035. Health data represents over 30% of the world’s data assets, yet less than 3% is utilized for secondary purposes such as research, regulatory, or public health purposes, a persistent “data-to-value” gap. This update examines how the EHDS Regulation seeks to close that gap by introducing a more prescriptive legal framework for access to health data for (certain) secondary use purposes whilst still aligning with requirements under EU privacy law; and what life sciences companies should be doing now to anticipate such secondary use obligations, data access requests, and opportunities.
EU Pharma Package: Sharp New Tools With Limited Protections (Part 1)
Last week, concluding a seven-year process, the Council of the European Union and the European Parliament agreed on the EU Pharma Package consisting of a new Pharmaceutical Directive and Pharmaceutical Regulation. The Package introduces pivotal changes to the EU pharmaceutical legislation, most significantly the introduction of new launch and supply obligations with only limited safeguards and a reduction and modulation of regulatory data protection and market protection, requiring companies to re-think their pipeline strategies. The provisional agreement now needs to be endorsed by both the Council and the Parliament before being formally adopted and entering into force upon publication in the Official Journal of the European Union. The final text is expected to become available in the coming weeks.
Navigating the European Health Data Space Regulation: What Life Sciences Companies Need to Know About Secondary Use Implementation (Now) – A Tracking Tool (Part 1)
The European Health Data Space Regulation took effect on March 26, 2025. While its key requirements regarding the secondary use of health data will not apply until March 2029, these provisions are set to bring about substantial changes for life sciences companies operating within the EU. This blog marks the beginning of a dedicated series of blogs exploring the implementation of the EHDS Regulation, with a particular focus on secondary use obligations. Our aim is to keep life sciences organizations informed about the latest EHDS Regulation developments, by offering an overview of relevant publications, consultations, and guidance on emerging best practices.