Fimea has released a guideline page on using artificial intelligence in medical devices

The EU AI Act (EU 2024/1689) entered into force on 1 August 2024, and its application is progressing in stages. The AI Act does not replace the MD and IVD Regulations concerning medical devices, but complements them by introducing new requirements, especially for high-risk AI systems. The aim is to ensure that using devices that utilise AI is safe, ethically sustainable and transparent throughout their life cycle.

Going forward, medical devices containing artificial intelligence (MDAI) fall within the scope of both the MDR/IVDR and the AI Act. This entails, among other things, additional obligations related to quality management, risk management, technical documentation, data management and transparency. 

Fimea has published a web page that compiles key information and requirements for using artificial intelligence in medical devices. The page will be updated in stages as the implementation of the Act progresses and new guidelines are prepared. It should be noted that the timetable for the Act entering into force may still change, as the details related to the application of the AI Act are still being discussed. The current content of the page is based on the valid AI Act.

Further information and guidelines will be published on the Fimea website as regulation and national legislation become more specific. If you have any questions, you can contact Fimea by email: [email protected].

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Using artificial intelligence in medical devices