Is the EU planning to clarify regulation of continuously learning AI in medical devices?

Question

I am looking for literature or official documentation indicating that the EU is planning to provide more clarity regarding the regulation of continuously learning or dynamic AI systems within medical devices. I have seen some unsubstantiated statements suggesting that the EU (though not clear which body, possibly the MDCG) may want to adopt approaches similar to the FDA’s Predetermined Change Control Plans (PCCP).
Can anyone point me to concrete evidence or official sources on this topic?

Dr. Oliver Eidel · Accepted Answer

I found evidence in a publication from VDE DGBMT, which argues that continuous learning systems are actually possible within the current regulatory framework, though this would require changes in practice. Additionally, the draft Artificial Intelligence Act (AIA) specifically references something that sounds similar to PCCPs in Article 43. This could be an indication that the EU is moving towards a more concrete regulatory approach for these types of AI systems.

Answer

The IG-NB guidance on AI states that continuously learning AI systems in medical devices are not currently possible, but there are rumors that this may change in the next version of the guidance. However, any change in non-binding guidance may not provide much regulatory clarity.

Answer

From my discussions with a Notified Body, they said that continuously learning systems are possible, but you need to put in significant effort to convince your Notified Body. The upcoming guidance may make this process more practical and reliable, but as of now, it still requires a strong justification.

Is the EU planning to clarify regulation of continuously learning AI in medical devices?

3 Answers

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