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Implementation: Notified Body Expectations & Readiness

Speaker:

Ibim Tariah, PhD (Technical Director, BSI Medical Devices)

Location: 210D

Date: Wednesday, February 7

Time: 10:15am - 11:45am

Pass Type: Conference (Paid) - Get your pass now!

Conference Track: MD&M: Regulatory & Quality Update

Vault Recording: TBD

European Notified Bodies may begin applying for designation under the EU MDR and IVDR starting November 26, 2017. The new rules will strengthen the surveillance of Notified Bodies by national authorities. For the medical device sector, the new regulation is a modernization of the original rules, bringing together best practices from existing commission guidance. For the in vitro diagnostics sector, this is a major overhaul of the rules. This session will cover what you need to know to be ready for the changes.

Topics to be covered include:

  • Changes to the EU MDR and industry’s reaction
  • How will Notified Bodies manage the changes needed by device manufacturers?
  • What is the implication for those holding CE marking certificates?