All Insights
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Regulatory Outlook
Products | UK Regulatory Outlook February 2026
General/digital products: EU product compliance: digitalisation and common specifications proposals | Proposal to amend EU regulations on AI rules Life
Life Sciences and Healthcare
Enactment of BBNJ Act brings UK closer to ratifying High Seas Treaty
Secondary legislation still required to meet treaty obligations before ratification
Life Sciences and Healthcare
Spain's Council of Ministers approves draft legislation on patient organisations
A consultation runs until 4 March on the legal framework for organisations' participation in the National Health System
Life Sciences and Healthcare
European Health Data Space Regulation and TEHDAS2 lay down a new roadmap for cross‑border data use
Europe takes the first steps to transform the regulatory framework into an operational ecosystem to reuse health data
ESG – Environmental, social and governance
ESG Knowledge Update | February 2026
Welcome to our Osborne Clarke ESG Knowledge Update, which offers a round-up of legal, regulatory and market news
Regulatory and compliance
Future Foods Takeaway | Brussels’ beef with plant-based food names
The alternative foods sector awaits with uncertainty for an outcome from the next round of EU talks on meat names
Life Sciences and Healthcare
EU device package envisages more support for 'orphan' and breakthrough products and flexible access in crises
In-house exemptions, 'orphan grandfathering', 'sandboxes' and crisis derogations aim to balance unmet needs with safety
Life Sciences and Healthcare
Draft EU medtech revisions adjust importer and distributor roles to support supply chain resilience
Digital obligations, leaner repackaging rules and new shortage reporting tools may evolve supply chain responsibilities
Life Sciences and Healthcare
Data-driven digital health businesses challenged with balancing AI advances and tighter regulation in 2026
Hyper-personalisation, data interoperability and AI are among 2025's fast-evolving areas to continue to watch this year
Life Sciences and Healthcare
EU MDR and IVDR poised to remain main framework for medical AI in draft AI interface reforms
Lex specialis treatment, integrated notified body reviews and clarified duties are designed to limit overlapping regulation of medical AI
Life Sciences and Healthcare
EU digital by default medtech plans signal shift in submissions, product information and online sales
E-submissions, digital documentation and clarified Eudamed and UDI duties to steer medtech towards fuller digitalisation
