Improving MDR Technical Documentation: Practical Lessons from the New Team-NB Guidance Revision

What the new Team-NB guidance means for MDR submissions

On 21 April 2026, Team-NB — the European Association of Medical devices Notified Bodies — adopted Version 4 of its Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of the MDR. The document reflects a collaborative notified body approach and is intended to support a more consistent understanding of what manufacturers should provide when submitting technical documentation.

Compared with earlier versions, Version 4 provides updated and expanded guidance on recurring reasons for technical documentation delays, communication with notified bodies before submission, documentation structure, translations, file format, file naming, and the consistency of duplicated information across the technical file. Practical submission details are also relevant here: the guidance recommends keeping individual PDF files to a maximum of 100 MB, limiting the combined file path and file name to 160 characters (with spaces counting as “%20”, i.e. three characters), using bookmarks or a dedicated table of contents for documents of 10 pages or more, and agreeing the folder structure with the notified body in advance.

The update also incorporates recent regulatory and technical developments across several documentation areas, including e-IFU requirements, AI Act considerations, software and cybersecurity, biocompatibility, chemical characterization, CMR and endocrine-disrupting substances, sterilization, packaging, SSCP, and post-market surveillance. More specifically, the guidance does not treat the AI Act as a separate documentation chapter; AI/ML-related expectations are addressed within product verification and validation and software documentation, including training and test data sets, reference to the EU Ethics Guidelines for Trustworthy AI, and the Team-NB/German NB Alliance questionnaire for AI in medical devices.

The practical message for manufacturers

One of the key messages of the guidance is that technical documentation should not be treated as a collection of individual reports. It should function as a connected compliance system.

This means manufacturers should ensure that the technical file clearly links device description, intended purpose, classification, GSPR compliance, benefit-risk analysis, risk management, verification and validation evidence, clinical evaluation, PMCF, PMS, and PSUR documentation. When these elements are not aligned, notified bodies may need to raise additional questions to understand how the evidence supports conformity.

A practical way to reduce this risk is to maintain a clear documentation structure with a logical index or table of contents, searchable files, consistent terminology, complete reports, and explicit links between evidence and the relevant MDR requirements.

Key areas covered by the guidance

The guidance follows the structure of MDR Annex II and Annex III and provides practical recommendations across the main sections of the technical file. These include:

Leveraging previous conformity assessment evidence

A particularly relevant part of the guidance concerns the use of evidence from previous conformity assessments, especially for manufacturers transitioning devices from the Directives to the MDR.

Team-NB explains that, in some cases, evidence previously assessed by a notified body may be leveraged to support MDR conformity assessment. However, manufacturers still need to provide full technical documentation under MDR Annex II and III. They should clearly indicate whether previously assessed evidence has changed, what the extent of any changes is, and where the evidence was previously reviewed.

This is especially important for legacy devices. Manufacturers should not assume that previous MDD evidence will automatically be accepted. Instead, they should make the connection transparent and provide references to previous assessment numbers, project IDs, or notified body reports where applicable.

For manufacturers, the value of the guidance is not only in understanding what must be submitted, but also how information should be presented so that notified body reviewers can efficiently follow the logic of compliance.

The full Team-NB guidance can be accessed here