Revised Team NB Position Paper on Best Practices for Submission of Technical Documentation under IVDR
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Revised Team NB Position Paper on Best Practices for Submission of Technical Documentation under IVDR
Regulatory Affairs In Vitro Diagnostics
Tuesday, 30 September 2025
Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
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On 3 September 2025, the Team-NB published a revised version of their position paper on Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746.
Revised Team NB Position Paper on Best Practices for Submission of Technical Documentation under IVDR | QbD Group
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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.
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