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Course Details

BSI's perspective on Article 117 and drug-device combinations webinar

Course Area

Medical Devices

Availability

Available for 90 days after enrollment

Approximate Course Run Time

1 hour

Continuing Education Units

0.1

Course Fee

No charge

E-learning content is available on demand!

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Course Details

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.

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.

What you will learn in this webinar:

  • 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

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Questions?

For questions regarding any of our courses, contact us or call 1.800.217.1390.

Questions?

For questions regarding any of our courses, contact us or call 800.217.1390 (USA) 800.862.6752 (Canada)

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