An industry survey conducted by KPMG and the Regulatory Affairs Professionals Society (RAPS) found little familiarity with the European Union’s new Medical Device Regulation and its requirements that take full effect in May 2020.
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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)