Recentes

• Securing Technology and Equipment (Operational Technology) Used for Medical Product Manufacturing
• New CTIS Guidance for Sponsors- Version 6.0
• Real-world evidence framework to support EU regulatory decision-making
• Implementing Decision (EU) 2025/1324, amending Decision (EU) 2019/1396, introducing changes to the governance and scope of expert panels under the Medical Devices Regulation (EU) 2017/745 and IVDR (EU) 2017/746.
• The new version of EUDAMED 2.15.0 has been deployed.
• Strategy to position the EU as the world’s most attractive place for life sciences by 2030
• New version released – TEAM NB Code of conduct for Notified Bodies
• 3rd progress report on the use of real-world evidence (RWE) in medicines regulation (February 2024 – February 2025)