EU Commission drafts guidelines on classifying high-risk systems under the AI Act
EU Commission drafts guidelines on classifying high-risk systems under the AI Act
Publish Date: 2026-06-02 15:37:00
Source Domain: www.raps.org
Here are seven key points from the article summarizing guidelines from the European Commission on the classification of high-risk AI-integrated medical devices under the EU’s Artificial Intelligence Act:
1. The European Commission has drafted guidelines to support companies in determining if their products containing AI components, particularly medical devices, are classified as high-risk under the AI Act.
2. These high-risk classifications will layer on existing obligations under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) but will not replace them.
3. The AI Act aims to govern and encourage the development of “human-centric and trustworthy” AI for medical purposes, including in vitro diagnostics and other medical devices.
4. The AI Act will come into effect on 2 December 2027 for stand-alone high-risk AI systems and on 2 August 2028 for AI systems embedded in products.
5. The Commission published three guidelines to explain its interpretation of high-risk products, focusing on general principles for classification, and addressing the content of Annex 1 and Annex III in the AI Act.
6. According to Nils Lölfing, specific high-risk AI systems under the act include those with significant potential impacts on human health, safety, and fundamental rights necessitating strict compliance measures.
7. Efforts are underway to prevent AI-integrated medical devices from being governed under multiple regulatory frameworks, such as the AI Act and the existing MDR/IVDR, by incorporating mechanisms to eliminate redundant requirements.
