Insights

The European Medicines Agency (EMA) has released an updated Questions & Answers document addressing the implementation of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).

This guidance provides essential information for marketing authorisation holders (MAHs), notified bodies (NBs), and applicants, clarifying regulatory requirements for drug-device combinations, companion diagnostics, and co-packaged medical devices. Key highlights include:

🔹 Integral Drug-Device Combinations (iDDCs): New requirements under Article 117 MDR, including the need for notified body opinions for medical devices forming part of a medicinal product.

🔹 Companion Diagnostics: Consultation procedures with EMA or national competent authorities are now mandatory under IVDR Article 48.

🔹 Co-Packaged Medical Devices: Updates on labelling requirements and transitional provisions for devices certified under previous directives.

These updates are crucial for ensuring compliance with evolving EU regulations and facilitating market access for medical devices.

👉 RPN will provide any further update and is available to provide full support for regulatory activities.