Medical device Notified Bodies (NBs) work with many types of combination products. This session aims to discuss the combination products in scope of notified bodies and their regulatory requirements. This will cover Integral drug device combinations, regulated as medicines but assessed by NBs under Article 117, device drug combinations that fall under Rule 14 as well as discuss integration of digital features into these combinations.
The Role of Notified Bodies in Combination Products
Dr Jonathan Sutch, BSI Group, UK
Dr Jonathan Sutch is a principal medicinal specialist at the Notified Body BSI Group, working with medical devices containing medicinal substances and drug/device combinations. Jon trained as a Pharmacist at the London School of Pharmacy prior to completing a PhD in Pharmaceutical Sciences at Nottingham University. He has 15 years of experience in the pharmaceutical industry as a formulation scientist and manager before moving to BSI 7 years ago.