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EU regulation emphasises centralised authorisation, precautionary principles, strong data protection, and post-market surveillance. Companies must also navigate both EU-level rules and national authority requirements.
EU life sciences law is complex and rapidly evolving, with overlapping EU and national rules requiring specialised, cross-border legal insight.
Consequences may include product recalls, fines, suspension of authorisations, civil liability and criminal sanctions under national laws.
Clinical trials are governed by the EU Clinical Trials Regulation (CTR), which introduces a single application via the Clinical Trials Information System (CTIS) and harmonised assessment across Member States.
Effective compliance programmes, internal audits, training and early legal advice help manage evolving EU regulatory obligations.
GDPR imposes strict requirements on the processing of personal and health data, including lawful basis, consent, data minimisation, and cross-border data transfers.
Yes, but special safeguards apply, including pseudonymisation, ethics approvals, and compliance with Member State-specific research exemptions.
Key issues include software qualification as a medical device, cybersecurity, data governance, algorithm transparency and obligations under the EU AI Act.
Life Sciences Lawyer