Life Sciences

life-sciences legal skills for European Union

Bringing a medicinal product or medical device to the EU market means navigating the European Medicines Agency's centralised authorisation pathway, the MDR and IVDR requirements administered through national competent authorities and notified bodies, and GDPR obligations that arise the moment clinical trial data touches a server. The intersection of those regimes — where a single approval project can generate regulatory submissions, clinical study agreements, pharmacovigilance obligations, and data-processing records simultaneously — is precisely where the Life Sciences legal skills in the ThomasMore catalog are designed to operate.

Each skill is agent-ready, built around the specific documents and decisions that life sciences counsel actually handle: drafting or reviewing clinical trial agreements under the EU Clinical Trials Regulation, mapping post-market surveillance duties under the MDR, screening licensing terms against EU competition rules on IP and technology transfer, or assembling GDPR Article 9 compliance checklists for sensitive health data. Reach them over MCP to slot into an active workflow or download them as reusable files for your team's library. The open-source contributions are maintained to track developments as the EMA issues new guidance, notified body capacity evolves, and the Health Technology Assessment Regulation's joint clinical assessments mature. Filter by practice segment — regulatory, transactional, data protection, or litigation — to surface the skills your current EU life sciences matter requires.