- Article 117 of EU MDR introduces the need for single integral medicinal products with a device component of class IIa and above to have a Notified Body opinion – what does this mean for combination product manufacturers? And what can manufacturers do to be ready for this change in regulations?
- Notified Bodies will have to apply for MDR designation – what will the impact on this have on the availability of Notified Bodies to meet growing demands and timelines?
- What will Rules on up classification mean for development and continued marketisation of Devices which will be up classified from class I to class IIa or b such as Rule 20 for inhalers?
Bjorg K. Hunter, Regulatory Manager, Devices, GSK
April Kent, M.Sc., B.Sc. Regulatory Affairs Manager, Combination products and IVDs, Amgen
Beat Steffen, Founder and Chief Executive Officer, confinis
James K. Mellman, Device Manager, Novartis
Torsten Kneuss, QA Manager Combination Products, Bayer