The European Medicines Agency and the Co-ordination Group for Mutual Recognition and Decentralized Procedures (CMDh) have issued a revised guidance that clarifies the information manufacturers should submit in new and existing applications for drug-device combination products. The guidance, which is in a question-and-answer format, incorporates major changes compared to a previous version issued in November 2023.
The guide should be read in conjunction with the revised Medical Devices Regulation (MDR), the In Vitro Diagnostic Medical Devices Regulation (IVDR) and Medical Device Coordination Group (MDCG) guidance documents. The MDR went into effect on 26 May 2021 while the IVDR came into force on 26 May 2022; both allow a transitional period for certain devices…
