Team-NB guidance on submission of technical documentation under IVDR

Team-NB has released a new position paper on the best practice guidance for submitting technical documentation under Annexes II and III of the IVDR. To develop a unified approach on technical documentation submissions from IVD manufacturers of all classes, this guidance addresses the most common reasons for delays in the submission of this documentation to Notified Bodies, which are:

  • Incomplete submissions;
  • Lack of a cohesive structure in the technical documentation.

As such, this document focuses on several relevant aspects such as:

  • Device description and specifications;
  • Information to be supplied by the manufacturer: DoC, Labels, IFUs, etc;
  • Design and Manufacturing information;
  • General Safety & Performance Requirements (GPSR);
  • Benefit-Risk Analysis and Risk Management;
  • Product Verification and Validation, which includes, among others:
    • Stability of reagents;
    • Metrological Traceability;
    • Chemical, Physical and Biological properties;
    • Requirements for devices with measuring functions;
    • Requirements for Software and Software validation;
    • Electrical Safety and Electromagnetic Compatibility (EMC);
  • Performance Evaluation, which includes, among others:
    • Product verification by EURL;
    • Performance Evaluation Plan;
    • Performance Evaluation Report
  • Post Market Surveillance;
  • Companion Diagnostics;

You can find all Commission and other relevant documents in the IVDR Notified Bodies and IVDR Position Papers section of our Library of Documents.

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