Team-NB: update on best practices for submitting technical documentation in accordance with IVDR

[2025-09-03] Team-NB (the European association of notified bodies for medical devices) published, on September 3, 2025, a new version of its guide on good practice for the submission of technical documentation, according to European Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).

New version of the guidelines

This is a 36-page PDF document, entitled “Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746” (version V2). It aligns with the requirements of the IVDR, described in detail in Annexes II and III, and in Article 29.

As with the previous version, it has been drawn up by the members of the Team-NB organization, on the basis of the various guidance documents published individually by the different notified body members of the association. Its aim: to establish a unified approach to expectations regarding the submission of technical documentation by manufacturers of in vitro diagnostic medical devices (IVDDs).

Modified content

The document remains largely identical to the first version of 2023 (see our previous article on the subject). These are mainly updates to bring the content up to date, clarify wording and improve the layout. We will mention the following additions to the document:

  • Note that when the IVDR is mentioned, this includes the latest amendments in relation to the published EU implementing and delegated regulations;

  • A handy table of abbreviations is also included;

  • In the chapter on IVDD description and specifications: when it comes to providing the list of reactive ingredients, add information on the presence of substances that are carcinogenic, mutagenic or toxic to reproduction (CMR). Also include an assessment in relation to Regulation (EU) 1272/2008 (on classification, labelling and packaging of substances and mixtures, known as “CLP” for “Classification, Labelling and Packaging”). Consider including the CAS number (unique registry number, issued by the Chemical Abstracts Service, for a substance);

  • The declaration of conformity must include, if necessary, the intended use of the IVDD for the device identification. In particular, if this cannot be clearly and unambiguously concluded from the name of the device;

  • In the chapter on meeting general safety performance requirements: addition of “state-of-the-art guidelines” alongside harmonized standards and common specifications;

  • In the section on product verification and validation:
    • If applicable, mention any sample preparation;
    • Analytical sensitivity: a description of the sample type should be provided, including surrogate samples, matrix, analyte levels and how the levels were established. If a surrogate sample is used, the manufacturer needs to provide a commutability study.

  • In the chapter on stability (in-use stability): clarification that the study protocol needs to represent routine use, and that automated and manual processing needs to be addressed separately;

  • for the section on electrical safety and electromagnetic compatibility: the list of relevant standards is separate for each subject, and more detailed ;

  • in the chapter on the performance evaluation report: a justification of the approach chosen to gather clinical evidence must be provided;

  • And other minor changes throughout the text.

Conclusion

It is a valuable and detailed guide for manufacturers, written by the very organizations that will be responsible for assessing the conformity of IVDDs technical documentation. The advice given should limit the number of non-conformities found during reviews, and thus speed up certification and product marketing.

For information, a similar document exists for medical devices other than IVDDs. A previous network article discusses the latest update, dated April 2025.

Article written by Christophe Saillet, member of the DMEXPERTS network.

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