Practical Guide: Submitting Technical Documentation under MDR (EU) 2017/745
News
Team-NB (the European Association of Notified Bodies for medical devices) is a professional organization that unites the main Notified Bodies (NBs) responsible for certifying medical devices within the European Union. This association promotes best practices and harmonization of certification processes, aiming to enhance the safety and compliance of medical devices across the EU, especially with the new requirements of the MDR (EU) 2017/745 regulation.
During a recent training session on CE marking technical files organized by Team-NB, we were reminded of their Best Practice Guide for Submitting Technical Documentation. This guide is an invaluable resource for manufacturers aiming to ensure compliance with MDR requirements. Here are the key points from the guide, plus a special offer at the end for our French-speaking clients.
Key Points from the Team-NB Guide
1. Purpose and Scope of the Guide
The guide aims to align expectations for submitting technical documentation for medical devices, following the requirements of Annexes II and III of MDR (EU) 2017/745. Although it is not exhaustive, it provides essential guidelines to help manufacturers meet standards when evaluated by a Notified Body.
2. General Considerations
Many delays in technical evaluations are due to incomplete or poorly organized submissions. Manufacturers are advised to consult with their Notified Body beforehand to clarify specific requirements, including language and documentation formatting.
3. Device Description and Specifications
Documentation must include details such as the product’s name, intended use, EMDN codes, and target users. The device classification must be justified, and any specific or new functionalities must be clearly identified. Ensuring consistency of information, particularly regarding variations, accessories, and configurations, is critical.
4. Information Provided by the Manufacturer
The submission should include the Declaration of Conformity (Annex IV of MDR), product labels, and Instructions for Use (IFU). Team-NB also reminds manufacturers of the obligation to publish certain information on their website, in accordance with MDR Annex I transparency requirements.
5. Risk Management and Benefit-Risk Analysis
The risk management process, based on ISO 14971, must be documented and should include detailed analysis for each device component. The risk management report must demonstrate that residual risks are acceptable and that the benefits for the patient outweigh these risks.
6. Product Verification and Validation
Biocompatibility, stability, and software validation tests (including cybersecurity) must be documented to demonstrate the device’s safety and performance. These tests should include detailed reports covering critical aspects of the device, contact materials, physical properties, and international testing standards.
7. Specific Requirements Depending on Device Nature
For devices containing medicinal substances, of human or animal origin, additional information is required, including safety justifications and evaluations. Documentation must include risk management analysis related to biological or active materials, when applicable.
Conclusion
The Team-NB guide is an invaluable tool for medical device manufacturers seeking MDR certification. By following these practices, manufacturers can streamline the compliance process and ensure a smooth transition to the MDR framework.
Also, check out our article: MDR Documentation: Avoid Common Mistakes and Follow Best Practices.
A French Version of the Guide: A Valuable Resource for Francophone Manufacturers
For our French-speaking clients, we offer a French translation of the Team-NB guide free of charge. This document simplifies access to MDR (EU) 2017/745 requirements, aiding manufacturers in understanding standards and preparing technical files for submission to Notified Bodies.
CSDmed: Your Partner in the Transition to MDR 2017/745
The European MDR 2017/745 introduces new requirements for medical devices, with more stringent demands on documentation, clinical evaluations, PMS procedures, and many other aspects of regulatory compliance.
At CSDmed, we help clients—whether start-ups, manufacturers, importers, or distributors—overcome the challenges of transitioning to MDR. Our team of experts and specialized consultants will guide you through the entire process, from achieving compliance to final certification.
🔗 Contact us to learn how our team can support you in successfully navigating your MDR transition.