AI Act Published in Official Journal of the EU: Harmonized Rules for AI Systems
July 12, 2024 – The Artificial Intelligence Regulation (AI Act), officially Regulation (EU) 2024/1689, has been published in the Official Journal of the European Union. This landmark regulation establishes harmonized rules for the development, market placement, service deployment, and use of AI systems within the EU. It significantly impacts regulatory requirements for various products and services, including medical devices and in vitro diagnostic (IVD) medical devices.
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Classification of AI Medical Devices and IVDs
The AI Act defines AI systems as “a machine-based system designed to operate with varying levels of autonomy, potentially exhibiting adaptiveness after deployment, and generating outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments.”
Most medical devices using AI technologies are classified as “high-risk” under the new regulations. This category includes systems that pose a significant risk to people’s health, safety, or fundamental rights. For these “high-risk” devices, compliance with both the AI Act and the Medical Devices Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR) must be verified by a third-party conformity assessment body.
Read more about medical device classifications in Europe
Timelines for Application
The AI Regulation will come into full effect on August 2, 2026, with several exceptions. Chapters I and II, covering “general provisions” and “prohibited practices,” will apply starting February 2, 2025. The following provisions will be effective from August 2, 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 will apply from August 2, 2027.
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