Join us live online for two half-day sessions on February 22-23, 2023 12:00p - 4:00pm ET.

During this virtual training, our hand-picked experts will share details about the changes to the standard and provide insight on other key topics around information security, the changing landscape, and new threats.

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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

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.

Live Online Classes

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Private Class

Interested in a private or customized version of this course? Request a quote.

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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