MDR – Notified Body Opinion – Article 117

09:30 - 10:05

The number of drug delivery devices, also known as ‘combination products’, entering the global market has grown significantly due to advances in medical technology as well as an increase in user demand. While these products have benefited millions of patients and hold great promise for the future of healthcare treatment, bringing them to market still involves a number of regulatory challenges, particularly within the European Union (EU). This presentation will discuss how a drug delivery device (e.g. prefilled syringe, on-body injector) is currently regulated within the EU as well as the impact of the new Medical Devices Regulation (Reg. 2017/745). In particular, the impact and challenges of the Notified Body Opinion requirement (Article 117) for prefilled devices will be discussed from an industry perspective

April Kent, M.Sc., B.Sc. Regulatory Affairs Manager, Combination products and IVDs, Amgen