Overview

Manufacturers of drug-device combination products need to be aware of the changes in Article 117 of the Medical Device Regulation (MDR). For drug-device combination products marketed as medicinal products where the combination is placed onto the market as an integral device, Notified Body involvement is required to confirm compliance with applicable General Safety and Performance Requirements of the MDR.

Key takeaways and learning objectives

• Overview of BSI and Notified Bodies

• Introduction of BSI’s Medicinal and Biologics team

• What Article 117 is all about and what drug-device combinations are impacted

• How the review for Notified Body Opinion (NBOp) works

• Documentation requirements by manufacturers  

• Learnings from NBOps already completed

• What the NBOp output looks like

Presenter information

Join Dr. Jennifer Durrant, Global Head of Medicinal and Biologics and Dr Jonathan Sutch, Medicinal Technical Specialist to hear about BSI’s perspectives on Article 117 and drug-device combination products.