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European Clinical evaluations with In Vitro Diagnostics are now governed by the In Vitro Diagnostic Regulation 2017/746 + update 2023/607
Understand the EU In Vitro Diagnostic Regulation (IVDR 2017/746) and its 2023 update. Learn how stricter classification rules, enhanced clinical evidence requirements, and reinforced post-market surveillance impact IVD compliance, performance evaluation, and market access in Europe.
5 feb 2023
European Regulation on personal data protection (EU/016/679)
Learn how the EU General Data Protection Regulation (GDPR 2016/679) impacts clinical research and data handling. Discover key compliance requirements, patient data protection obligations, and best practices for managing personal data in clinical trials within the EU.
5 feb 2023
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