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Course Details

Performance Evaluation under the In Vitro Diagnostic Regulation - Part 2 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

Join this webinar to hear Dr Erica Conway, BSI’s Global Head of IVD Medical Devices and Dr Liz Harrison, IVD Technical Team Manager at BSI, talk about the Performance Evaluation requirements under the In Vitro Diagnostic Regulation (IVDR) – Part 2. 

Topics covered will include:

  • Clinical performance as part of the Performance Evaluation, including clinical performance studies under Annex XIII
  • Post-market Performance Follow-up (PMPF) and the continuing the process of maintaining clinical evidence 
  • This will include initial lessons learned from our first IVDR submissions, and areas under discussion 

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