• Steps needed for a Notified Body Opinion
• Industry Experiences and Challenges
• Learning & best practices related to compliance with Article 117 MDR

This presentation outlines key strategies for successfully obtaining a positive notified body opinion, incorporating the experiences of 14 EFPIA member companies with Article 117 over the past three years. It highlights both the progress made and the challenges encountered in dossier submissions. Emphasizing the importance of early engagement and proactive planning, the presentation advocates for streamlined submission processes. Furthermore, it calls for enhanced communication and collaboration among the EMA, NBs, and the Medical Device Coordination Group (MDCG) to improve regulatory guidance and approval timelines. Ultimately, fostering collaboration among stakeholders is crucial for overcoming existing challenges related to integral drug-device combination products.

Michael Kuehler

Regulatory Affairs Senior Expert for Medical Devices

Bayer AG