The introduction of the MDR has brough in some additional requirements and challenges for combination products. This session will discuss the progress and learnings with examples, focussing on Article 117 combination products requiring Notified Body Opinions and Rule 14 devices with ancillary medicinal products requiring Competent Authority consultations. The session will cover the process and documentation required for these regulatory routes, the common pain points as well as point to available guidance.
Notified Bodies’ experience with 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.