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

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

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.

Discover more expert content

Discover all

Stay ahead in life sciences

Keeping up with the fast-paced life sciences industry doesn’t have to be overwhelming.

Our newsletter delivers the latest insights, industry updates, and expert content directly to your inbox, helping you stay informed and make smarter decisions.

Subscribe to our newsletter

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

What does this mean for you?

Discover more expert content

Revision of MDCG 2019-13 released

New revisions of the Preliminary Assessment Review templates, forms and annexes

New Manufacturer Incident Report template and IMDRF terminologies for categorized Adverse Event Reporting released

New revision of Team-NB Position Paper on European AI Act

New Team-NB Position Paper Released on IVDR certification process

Stay ahead in life sciences