News & Trends
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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)