Members of Team NB have released version 2 of their "Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of Medical Device Regulation (EU) 2017/745".

Key Takeaways:

🔹 Developed by Team NB for unified technical documentation submissions​​.

🔹 Includes administrative manufacturer details, device usage, and classification rationale​​.

🔹 Legible labels and intended sale countries must be indicated​​.

🔹 Details on design, manufacturing, and critical ingredients required​​.

🔹 Compliance with applicable General Safety and Performance Requirements (GSPR) must be demonstrated​​.

🔹 Risk management and performance evaluation interface should be clear​​.

🔹 Documentation should justify required level of clinical evidence​​.

🔹 Plans for post-market follow-up and surveillance should be outlined​​.

🔗 Original Document :  https://www.team-nb.org/wp-content/uploads/members/M2023/Team-NB-PositionPaper-BPG-TechnicalDocEU-MDR-2017-745-V2-20230419.pdf