Understanding Regulation (EU) 2017/745, Article 117 for Combination Devices

Filmed on April 17, 2024 - This webinar addresses regulatory considerations associated with notified body opinion (NBOp) in accordance with Article 117 of the EU Medical Devices Regulation (EU MDR)1 for medicinal products that incorporate a nonreusable medical device. 0:00 Introduction 3:12 EU Medical Device Definitions: MDD vs MDR 3:55 DDC Products: Device Components Under MDD 5:07 Article 117 6:28 Examples of devices in scope 7:07 Drug and Device Combination Products: EU Approval Pathways 10:36 Impact of Article 117 on Medicinal Product Manufacturers 12:25 Safety and Performance Requirements 17:28 Notified Body Role 20:29 Notified Body Assessment Report 21:33 Notified Body Assessment of Changes 23:53 EU Regulations Timeline Extensions 25:48 Selected Q&A on Practical Aspects of Implementation of Regulation (EU) 2017/745 31:36 Q&A Session Speakers Ibim Tariah - Technical Business Development Director – Medical Devices, SGS North America Greg Jacobson - Sales Director - Medical Devices, SGS Learn more: https://bit.ly/4bZxqHX Follow us on LinkedIn: https://bit.ly/44lmAY1