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Course Details

In Vitro Diagnostic Regulation (IVDR) Application Process 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

The IVDR was published on 5 May 2017 and manufacturers will need to start complying with it by May 2022 in order to be able to place their devices on the EU market. The challenge, until very recently, was that no notified body was approved to undertake conformity assessments under the new, more stringent, legislation. BSI is one of the first to achieve designation to the IVDR with both BSI Netherlands and UK Notified Bodies now being able to provide conformity assessments to the full scope of the IVDR, which includes over 80 codes. 

For IVD manufacturers wishing to apply with BSI, join this webinar to hear Todd Moorman provide guidance on how to prepare a successful IVDR Application.

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