The integration of Artificial Intelligence (AI) in medical devices is transforming the healthcare sector, offering innovative opportunities for diagnosis and treatment.
However, this technological advancement comes with regulatory challenges, particularly with the introduction of the European Union’s Artificial Intelligence Act (AI Act) and the Medical Device Regulation (MDR).
Understanding these regulatory frameworks is essential for manufacturers aiming to develop AI-based medical devices.
1. Understanding the AI Act and Its Interaction with the MDR
The AI Act, adopted in 2024, establishes a legal framework for the use of AI within the European Union, classifying AI systems according to their level of risk. Medical devices incorporating AI are generally considered high-risk systems, subject to stringent requirements concerning safety, transparenc
At the same time, the MDR, in effect since 2021, governs the market placement and post-market surveillance of medical devices, with a strong focus on safety and clinical performance. The interaction between these two regulations means that manufacturers must navigate a complex regulatory landscape to ensure product compliance.
2. Expectations from Notified Bodies and Key Considerations for Manufacturers
Notified bodies play a key role in assessing the compliance of medical devices. With the implementation of the AI Act, these bodies must now have specific expertise in AI to properly evaluate affected devices. Manufacturers should therefore:
– Strengthen Risk Management: Implement robust processes to identify, assess, and mitigate risks specific to AI.
– Ensure Algorithm Transparency: Clearly document how AI algorithms work to facilitate evaluation by notified bodies and build user trust.
– Guarantee Data Quality: Use representative, unbiased datasets to train algorithms, ensuring reliable and fair performance.
– Prepare Comprehensive Technical Documentation: Include detailed information on the development, validation, and post-market monitoring of AI systems.
By adopting these practices, manufacturers can not only comply with regulatory requirements but also enhance the quality and safety of their AI-based medical devices, contributing to responsible innovation in healthcare.
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Celine Efaiki
Community Manager
