Q1/ 2026 - Life Sciences Law Update

Pharma

Final texts of the new directive and regulation published for the EU Pharma Package: As previously reported, the Package revises EU pharmaceutical law by replacing both, Regulation (EC) No 726/2004 and Directive 2001/83/EC. Key measures include inter alia: (i) a recalibrated regulatory framework ament to incentive innovation, but also fosters generics, (ii) shortened market exclusivity for certain Orphan Medicinal Products, and (iii) strengthened obligations for supply and shortage‑prevention. The European Commission published the final texts and EU institutions will conduct legal‑linguistic review and translations before formal adoption, currently expected in the second half of 2026. No further substantive changes are anticipated at this stage.

The EU is advancing several initiatives to improve clinical trial processes:

• Draft EU guidance to streamline clinical trials during public health emergencies: This initiative aims to harmonize and accelerate approvals for new clinical trials and CT amendments, clarify how to adapt/continue ongoing trials, and address operational issues (e.g., site transfers) while safeguarding participant rights, safety, and data integrity. It also encourages early scientific advice from EMA's Emergency Task Force.
• FAST-EU pilot speeds multinational clinical trial authorisations: A coordinated fast-track procedure for the authorisation of multinational clinical trials in the EU/EEA is being launched as a pilot under FAST-EU. The initiative is designed to make assessment timelines more predictable and efficient while maintaining scientific, safety, and ethical standards. It reflects the EU's broader effort to strengthen clinical research competitiveness. For sponsors, this may improve planning certainty and support faster study start-up across multiple Member States, particularly for complex multinational trials.
• Furthermore, the EU Biotech Act aims to standardise data protection measures for clinical trials (see "Intersection of Data Privacy and Life Sciences” below).

Medical Devices

European Commission Proposal on MDR/IVDR Simplification: In Q4 2025, the European Commission proposed amendments to MDR and IVDR to simplify regulations, reduce administrative tasks, and improve certification while maintaining patient safety. The plan would make MDR the main framework for AI medical devices/IVDs under the AI Act. The amendment moves AI medical devices and AI IVDs to Annex I, Section B of the AI Act. As a consequence, the high-risk requirements of the AI Act (e.g., risk management, data governance, transparency, human oversight, robustness, cybersecurity) would no longer directly apply under the AI Act. However, these obligations may be transferred to the MDR/IVDR via delegated/implementing acts. Industry groups like MedTech Europe and BVMed support transferring AI medical devices/IVDs from Annex I Section A to Section B in the AI Act, citing reduced duplication and greater legal certainty. Conversely, critics such as TÜV-Verband are concerned that these changes could weaken patient safety and negate investments made in existing AI compliance. It has to be seen whether the proposal makes it into the law, though this seems likely.

New Medical Devices Coordination Group (MDCG) published new guidance:

• MDCG 2025-8 rev. 1: Guidance on the implementation of the Master UDI-DI solution for spectacle frames, spectacle lenses and ready-to-wear reading spectacles
• MDCG 2019-6 rev. 5 Q&A: Requirements relating to notified bodies.

Omnibus legislation proposing inter alia amendments to the Corporate Sustainability Due Diligence Directive (CSDDD) and sustainability reporting finally entered into force: As previously reported, the substantive Omnibus Directive (EU) 2026/470 was in the final stages of the legislative process. Such process has now been completed with the approval of the EU Council on 24 February 2026, publication in the EU Official Gazette on 26 February 2026, and entering into force on 18 March 2026. Agreed amendments, as already mentioned in our last update, now include, inter alia: (i) for the CSRD further limiting the scope for EU companies (at least 1,000 employees and net turnover EUR 450m), simplification and reduction of reporting requirements, prohibition to obtain information only for CSRD reporting from entities in the value chain with less than 1,000 employees other than information to be specified in the sustainability standards for voluntary use, and (ii) for the CSDDD further limiting the scope for EU companies (at least 5,000 employees and net turnover EUR 1.5bn), removal of requirements to adopt and implement a climate transition plan, change of diligence obligations to a risk-based approach, no EU harmonized civil law liability regime, and deferral of transposition deadline to 26 July 2028.

EU Commission presents proposal for an EU Inc. to make it easier to start and operate business across the EU: As part of the new broader 28th regime, the EU commission presented a proposal for an EU Inc., a new single set of corporate rules applying across the entire EU intended to make it easier to start, operate and grow a business across the EU. Main features shall include a faster and simpler registration process, fully digital operations throughout the lifecycle, simplified liquidation procedures, digital procedures for financing, simplified share transfers, and full access to the single market, while maintaining strong national safeguards against abuse. Due to the urgent need to enhance the EU's competitiveness, the Commission has requested the Parliament and the Council to reach an agreement on the EU Inc. proposal by the end of 2026.

Revision of horizontal merger guidelines: The European Commission is expected to publish revised horizontal merger guidelines at the end of April 2026, with a stronger focus on supply chain resilience and innovation, which prompted a discussion about the creation of “European champions” in strategic sectors. The update – drawing on experience under the EU Merger Regulation and Mario Draghi's 2024 competitiveness report – can impact life sciences companies in particular with regards to R&D collaboration, manufacturing capacity, and supply chain security.

Transparency International's Corruption Perceptions Index 2025 reveals increasing global corruption risks: Transparency International's 2025 Index covers 182 countries, showing a drop in the global average score to 42, with 122 countries scoring below 50—signalling widespread public-sector corruption. Only five nations now score above 80, down from 12 ten years ago; traditional democracies like the US, Canada, New Zealand, UK, France, and Sweden have seen their scores worsen. The 50 biggest declines often occur where civic space is restricted, and journalists killed investigating corruption are mostly in low-scoring countries, highlighting links between repression and corruption. Transparency International notes lasting progress relies on political will, strong oversight, and protecting democracy; centralized power and weak accountability lead to persistently low or falling scores.