AI Act Timeline for Medical Device Software

Applicability for MDSW

For “general” AI medical devices, the AI Act will be applicable from 02-08-2027 (mark that date in your calendars) if any of the following two cases apply:

• Your AI is a product (for which there is no specific definition but let’s say you intend to brand and market your AI for a specific purpose) and that product is required to undergo a third-party conformity assessment under the Medical Devices Regulations. This means that if your medical device already requires Notified Body involvement, the AI Act will apply as well.

  If your AI is not a product in itself and does not require NB involvement under the MDR, the AI Act may still apply if:

• Your product is intended to be used as a safety component of another product. ChatGPT gave me the example of an AI-driven sensor system integrated into a larger patient monitoring device to ensure precision and safety. It can, however, always be argued whether such safety components are not already accessories to medical devices or medical devices in their own right. What this does mean (looking at the ‘is your AI a product’ part of the previous point) is that although your AI is part of another product and you do not specifically market it as a product, the AI Act may still apply if it is a safety component to another product.

Unfortunately, no. If you are a medical device incorporating AI or AI in itself, the MDR still applies and you must comply with MDR requirements, including Notified Body involvement. As Notified Bodies require you to apply state-of-the-art practices, it is likely that you will need to apply international standards that currently inspire AI Act harmonized norms. You will still need to demonstrate the development and validation of your AI as part of your quality management system.

What does this mean?

AI Act requirements greatly overlap with MDR requirements, and you will comply with AI Act requirements as part of obtaining your MDR CE marking, maybe without even specifically knowing it.

What to do?

 Ensure you are aware of the requirements, best practices, and relevant ISO norms to apply to the development and validation of AI medical devices in preparation for your MDR CE-marking and from 2027 your AI Act and MDR CE-marking.