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Revised Team NB Position Paper on Best Practices for Submission of Technical Documentation under IVDR

Regulatory Affairs In Vitro Diagnostics
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Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
Revised Team NB Position Paper on Best Practices for Submission of Technical Documentation under IVDR | QbD Group
0:43

The revision includes updates to various sections and brings the content up-to-date. Additionally, clarification in wording and improved formatting is included.

 

What does this mean for you?

IVD manufacturers should review the updated paper to ensure their technical documentation meets current best practice expectations, reducing the risk of regulatory queries and facilitating smoother conformity assessments.

 

CTA RA update

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