Team-NB Best Practice Guidance V2 on IVDR Technical Documentation Submissions (Annex II & III)

Team-NB has published the first revision of its Best Practice Guidance for the submission of technical documentation pursuant Annex II and III of the In Vitro Diagnostic Medical Devices Regulation (IVDR) (EU) 2017/746.

This guidance aims to:

• Harmonize notified bodies’ expectations for technical documentation submissions
  Provide manufacturers with a clear, structured framework for preparing their technical documentations
  Reduce delays caused by inconsistencies or missing information during conformity assessment activities
• Emphasize compliance with General Safety and Performance Requirements (GSPRs), risk management, performance evaluation, and post-market surveillance requirements

With this harmonized guidance, notified bodies aim to support manufacturers in drafting robust technical documentation that demonstrates both regulatory compliance and the highest standards of patient safety and device performance.

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