Team NB Publishes New Good Practice Guide for the Submission of Technical Documentation under the MDR
Team NB, the European association of Notified Bodies for medical devices, published Version 3 of its good practice guide for the submission of technical documentation under Annexes II and III of Regulation (EU) 2017/745 (MDR) in April 2025. This document aims to standardize expectations among Notified Bodies and support manufacturers in preparing more complete, clear and compliant technical dossiers.
Objectives of the document
The guide sets out practical and structured recommendations to ensure that technical files:
Be complete, coherent and easily navigable;
Are aligned with the requirements of the MDR, including demonstrating compliance with the General Safety and Performance Requirements (GSPRs);
Reduce delays and rework during assessments by Notified Bodies.
Highlights of the guide
Organization of technical documentation
A logical structure is recommended, with a table of contents, internal hyperlinks and consistency of terminology (e.g. product name, UDI, intended use).Common mistakes to avoid
The guide identifies frequent failures, such as inconsistent data, poor quality translations, gaps in the risk assessment or inaccurate references in technical dossiers.Reinforced pre-submission communication
Manufacturers are encouraged to consult Notified Bodies in advance to clarify language requirements, accepted formats, and folder structure.Use of previous data
In some cases, it is possible to reuse data that has already been assessed under the previous Directive (MDD), provided that it is properly referenced and still valid in relation to the state of the art.Focus on the life cycle of the device
The guide reinforces that technical documentation should reflect a holistic and continuous approach, covering everything from design to post-market surveillance.
Implications for manufacturers
This guide represents a strategic tool to ensure more effective, transparent submissions in line with the expectations of Notified Bodies. Its adoption can significantly reduce the time and resources spent on requests for clarification or corrections during conformity assessment processes.
How Smart MDR can support
The Smart MDR team has consolidated experience in supporting the preparation and review of technical documentation under the MDR. We can help with:
Structuring and reviewing the technical dossier;
Preparation of GSPR checklists and traceability maps;
Review of clinical documentation and risk assessment;
Communication with Notified Bodies.
Contact us to ensure that your submission is in line with the best practices in the sector.
Be Smart. Be Compliant.
