Team-NB Releases AI Questionnaire on MDR and IVDR

Team-NB has released a position paper and a questionnaire with IG-NB addressing the integration of Artificial Intelligence (AI) within medical devices under the current Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

How Does the Team-NB AI Questionnaire Align with MDR, IVDR, and Future Regulations?

The questionnaire, aligned with the Medical Device Coordination Group’s (MDCG) 2022-14 requests, is understood in the context of the MDR and IVDR regulations and MDCG guidance on software as a medical device (MDSW). It does not yet incorporate specific stipulations from the AI Regulation 2024/1689, which will be included in an upcoming comprehensive revision.

Despite this, the questionnaire acknowledges the significant overlap between the AI Regulation and the existing regulatory and standards framework for software and AI.

The questionnaire emphasizes that ensuring the safety of AI-based medical devices requires a focus on the processes involved rather than just the products themselves. It advocates for a process-oriented approach that takes into account all relevant life cycle stages and processes to achieve safety in AI-integrated medical devices.

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Team-NB’s position paper highlights the need for a process-focused approach to AI in medical devices. This collaborative effort helps shape future regulatory frameworks, with stakeholders encouraged to engage in shaping the evolving landscape of AI-driven medical device regulations. For guidance on navigating evolving regulations, contact us today.

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