Team-NB, the European Association of Medical Devices Notified Bodies, has published Version 3 of its “Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of Medical Device Regulation (EU) 2017/745.” This updated guidance aims to harmonize expectations between manufacturers and notified bodies, enhance transparency, and improve the quality of conformity assessment submissions.
Scope and Key Updates
The revised guidance provides detailed recommendations on structuring technical documentation in line with MDR Annexes II and III. It covers essential aspects such as:
- Comprehensive device descriptions, including variants and configurations.
- Compliance with General Safety and Performance Requirements (GSPRs).
- Non-clinical testing, clinical evaluation, and clinical evidence.
- Post-market surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) planning.
Labelling and instructions for use.
Notably, Version 3 has expanded from 47 to 79 pages, incorporating practical insights from notified body audits and market observations. It introduces “Common Pitfalls” sections at the end of each chapter, highlighting frequent deficiencies ranging from incorrect UDI assignments to misuse of terminology and issues related to risk management. Moreover, they provide practical solutions aimed at enhancing the effectiveness of the conformity assessment process.
Recommendations for Manufacturers
Team-NB emphasises the importance of:
- Ensure your technical documentation follows the MDR format, avoiding outdated structures from MDD submissions.
- Ensuring documentation is device-specific, reflecting intended purpose, clinical context, and risk profile.
- Establishing strong links between sections like GSPR and risk analysis, PMS and PMCF, for a coherent dossier.
- Avoiding excessive annexes or scattered evidence to facilitate navigability.
- Implementing version control, dating, signing, and clear referencing of all documents to prevent formal gaps.
These recommendations aim to enhance mutual understanding between stakeholders and help reduce review timelines and documentation deficiencies. They support a harmonised approach to MDR interpretation and contribute to improving the overall efficiency and predictability of the certification process across Europe.
To assist manufacturers in adapting to these updates, Team-NB has scheduled the ninth session of its MDR Technical Documentation Training for Manufacturers on June 17, 2025. This session will provide in-depth insights into the updated guidance and offer practical advice for compliance.
