The European Commission has published draft guidelines to help developers determine whether their artificial intelligence (AI) qualifies as ‘high-risk’ under Article 6 of the AI Act. For developers of AI-enabled medical devices, the stakes are particularly high: those whose products are classified as high-risk will be required to comply with both the EU AI Act and the existing EU Medical Device Regulation (MDR) and EU In Vitro Diagnostic Regulation (IVDR) frameworks.
The draft guidelines, published in May 2026, follow an agreement reached between the European Parliament and the European Council on the AI Omnibus, which delays high-risk obligations coming into force until December 2027 for standalone AI systems, and August 2028 for embedded AI systems. While machinery products have been granted an exemption to comply only with sector-specific regulations, no equivalent exemption has been put in place for medical devices, which will continue to need to comply with both the EU AI Act and EU MDR/IVDR. The agreement does, however, suggest a mechanism through which, where sector-specific legislation contains similar AI requirements to the AI Act, the latter’s requirements can be limited through implementing acts.
The classification guidelines come in three parts: one covering general principles for the classification of high-risk AI products, and two focusing on Annex I (regulated products) and Annex III (high-risk AI systems) of the AI Act. As per Article 6(5) of the EU AI Act, the guidelines aim to provide practical examples of use cases.
The guidelines are open for consultation until the 23 July, following an extension granted in response to stakeholders’ requests, with the final guidelines expected to be adopted by the end of 2026, according to the Commission website.
An announcement regarding a new Scientific Panel and an Advisory Forum to support enforcement of the EU AI Act was also announced in June. Both bodies will advise the AI Office at the Commission and national authorities on applying the rules. The Scientific Panel, comprising 60 experts, will focus on areas such as general-purpose AI (GPAI) classification and supporting market surveillance activities, while the Advisory Forum, made up of 174 members, will provide broader stakeholder feedback and technical expertise on specific implementation issues related to the EU AI Act, including standardisation.
