Today, 12 July 2024, the Artificial Intelligence Regulation (AI Act) was published in the Official Journal of the European Union. Regulation (EU) 2024/1689 sets harmonised rules for development, placing on the market, putting into service, and use of AI systems in the Union. The AI Act implementation impacts regulatory requirements for different products and services, including medical devices and IVD medical devices.
Classification of AI medical devices and IVDs
The Regulation defines AI systems as as “a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments”.
Under the new AI rules, the majority of medical devices using AI technologies are classified as “high-risk”. Under the AI Act, this risk category includes systems that can pose a significant risk of harming people’s health, safety, or fundamental rights. For “high-risk” devices, a third-party conformity assessment body has to verify compliance with both the AI and MDR or IVDR requirements.
Timelines to application
The AI Regulation applies from 2 August 2026 with some exceptions. Chapters I and II, on “general provisions” and “prohibited practices”, apply already from 2 February 2025. The following provisions apply from 2 August 2025:
- Chapters III section 4 on notifying authorities and notified bodies
- Chapter V on classification rules
- Chapter VII on governance
- Chapter XII on penalties
- Article 78 on confidentiality
Obligations for high-risk devices apply from 2 August 2027.
Do you have questions on AI medical devices’ compliance? Contact us here.
Leave a Reply