Team-NB Updates Best Practice Guidance on MDR Technical Documentation ⚕️ Pure Clinical

Team-NB Updates Best Practice Guidance on MDR Technical Documentation

The updated Team-NB guidance on technical documentation provides manufacturers with a comprehensive framework to build MDR-compliant technical files. While non-binding, the document is widely regarded as a reference standard by many notified bodies. Version 3 incorporates updates based on real-world assessments and lessons learned across the sector.

Scope of the Team-NB guidance

The guidance elaborates on the structure and content of technical documentation in line with MDR Annexes II and III, covering:

full device description, variants, and configurations,
compliance with General Safety and Performance Requirements (GSPRs),
non-clinical testing, clinical evaluation, and clinical evidence,
post-market surveillance (PMS) and PMCF planning,
labelling and instructions for use.

Recommendations from Team-NB

The document offers actionable insights to improve both document quality and review efficiency:

Manufacturers should align documentation strictly with MDR format, avoiding legacy structures from MDD/IVDD submissions.
Avoid generic templates, Documentation must be device-specific, reflecting intended purpose, clinical context, and risk profile.
Strong links between sections (e.g., GSPR ↔ risk analysis, PMS ↔ PMCF) are essential for a credible and coherent dossier.
Excessive annexes or scattered evidence should be avoided. The file should be easily navigable for reviewers.
All documents should be version-controlled, dated, signed, and clearly referenced—formal gaps may lead to non-conformities.

Impact on manufacturers and notified bodies

The guidance enhances mutual understanding between stakeholders and helps reduce review timelines and documentation deficiencies. It supports a harmonised approach to MDR interpretation and contributes to improving the overall efficiency and predictability of the certification process across Europe.

Read the article: Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of Medical Device Regulation (EU) 2017/745