Regulatory news Normativa europea 21 febbraio 2025 EMA Updated Questions & Answers on Implementation of MDR and IVDR (specifically in regard to Integral Drug-Device Combinations (DDCs))
Normativa europea Regulatory news 17 febbraio 2025 EMA establishes regular procedure for scientific advice on certain high-risk medical devices
Normativa europea Regulatory news Sperimentazione clinica 7 febbraio 2025 Medical Devices: Clinical investigations and performance studies - Pilot coordinated assessment
Normativa europea Regulatory news 24 gennaio 2025 HTA Regulation: Commission adopts rules for joint scientific consultations on medical devices and in vitro diagnostic medical devices
Regulatory news 5 dicembre 2024 EU joint HTA estimated activity in 2025 following the new HTA Regulation
Sperimentazione clinica Normativa europea 3 giugno 2024 Europe - Updated EC Guidance for the Transition of clinical trials from the CTD to the CTR (version 4)
Regulatory news Normativa europea 22 maggio 2024 Medical devices: new guidance for industry and notified bodies
Normativa europea Regulatory news 24 aprile 2024 New recommendations to strengthen supply chains of critical medicines
Regulatory news Autorità nazionali 18 marzo 2024 Sostanze medicinali ancillari nei dispositivi medici
Normativa europea 4 agosto 2023 Reflection paper on the use of artificial intelligence in the lifecycle of medicines
