Simplify Regulatory Compliance for AI-Powered Medical Devices with the Team NB and IG-NB Questionnaire
MD, AI and Cybersecurity
Artificial intelligence (AI) is playing an increasingly significant role in the medical device industry. In response to the technical and regulatory challenges this brings, the questionnaire developed by Team NB and IG-NB serves as a valuable tool for manufacturers striving to demonstrate the compliance of their AI-powered medical devices with the MDR (2017/745) and IVDR (2017/746) regulations. This document, created with the support of the Medical Device Coordination Group (MDCG), offers a systematic approach covering the entire product lifecycle—from design to post-market surveillance.
Why is this questionnaire essential?
The Team NB and IG-NB questionnaire addresses a specific request from the MDCG: to provide manufacturers with a unified guide for structuring their regulatory compliance processes. However, its significance extends far beyond this goal:
1. Comprehensive approach: It tackles key areas such as risk management, data validation, AI model documentation, and post-market surveillance.
2. Strong references: It is based on recognized norms and regulations (MDR, IVDR, ISO 14971) and emerging standards for AI.
3. Adaptability: While designed for medical devices, its methodologies can be applied to other industries facing similar technical challenges.
Preparing for the AI Act: An Added Value
Although the questionnaire is not specifically designed to address the upcoming European AI Act, it effectively prepares manufacturers for some of its fundamental principles:
- Data quality and traceability: Sections on data collection, validation, and processing align with the transparency and bias prevention requirements of the AI Act.
- Continuous monitoring: The questionnaire emphasizes the ongoing evaluation of AI model performance, a central obligation under the AI Act.
- Risk management: By identifying potential model drifts (concept drift, data drift), it anticipates challenges unique to evolving AI systems.
However, additional steps will be required to fully meet the AI Act’s demands, particularly regarding the classification of AI systems and adherence to ethical principles.
A Ready-to-Use Tool: Download the Questionnaire in Excel
To further simplify the use of this questionnaire, we’ve transformed its content into an interactive Excel file:
- Original version in English: Organized to facilitate response entry and tracking.
- French version: Carefully translated for Francophone manufacturers.
These files are designed to guide you through regulatory compliance, making it easier to analyze requirements and implement necessary actions.
Download Your Free Excel Version
Take advantage of our free adaptation of the Team NB and IG-NB questionnaire by clicking the links below:
These tools represent a vital step in structuring your compliance efforts and ensuring the safe market release of your AI-powered medical devices.
Team NB and IG-NB: A Key Reference for AI-Powered Medical Devices
The Team NB and IG-NB questionnaire is an essential reference for manufacturers of medical devices incorporating AI. Whether you are preparing for MDR/IVDR certification or anticipating the requirements of the AI Act, this tool enables you to organize your processes systematically and rigorously. Don’t wait—download our interactive Excel version today and move confidently toward compliance.
CSDmed: Your Partner for AI-Integrated Medical Devices
The European MDR 2017/745 and the AI Act introduce new requirements for medical devices integrating AI, including stricter demands for documentation, clinical evaluations, PMS procedures, and many other aspects of regulatory compliance.
At CSDmed, we help our clients—startups, manufacturers, importers, and distributors—overcome these challenges. Our team of experts and specialized consultants supports you throughout the entire process, from compliance to final certification.
🔗 Contact us to discover how our team can assist you.