Course Details

IVDR Regulatory updates

Student taking online training

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

With the IVDR having entered into force on 26 May 2022, there are still many questions and challenges for IVD manufacturers facing the difficult task of implementing the regulation. Join this insightful webinar to hear about the latest IVD regulatory updates.

Key takeaways and learning objectives

This webinar will provide attendees with the latest BSI knowledge and best practise with regards to IVDR Regulatory Updates. This will include:

  • A short recap on where the IVDR is (latest MDCG guidance and developments in Brussels)
  • Description of the challenges for Class D IVD’s and the status on EU Reference Labs
  • Envision the potential ramifications for manufacturers of these updates.

This webinar will be of particular interest to manufacturers of IVD devices. It will also offer notified body insights for all people involved in working towards an IVDR application, whether you are a novice or have experience of working with a notified body.

Join this insightful webinar to hear subject matter expert, Alex Laan, Global Head of IVD at BSI share his knowledge, hints, and tips on latest IVD regulatory updates. You will also gain a better understanding of the status related to IVDR and envision the potential ramifications for manufacturers of these updates.

Presenter information

Speaker - Alex Laan, Head of IVD Notified Body, BSI

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Questions?

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

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