One assessment
The MDR/IVDR notified body assesses the AI Act requirements as part of its procedure, if it is designated for them.
Your mandated EU point of contact under Article 22 of the AI Act
AI that is a medical device, or a safety component of one, and that requires a notified body under the MDR or IVDR is a high-risk AI system under Article 6(1). The AI Act requirements apply on top of the device rules - through one conformity assessment.
Class I devices that are self-declared are not high-risk under Article 6(1) on this basis. Since Regulation (EU) 2026/1744, AI used solely for non-safety aspects such as user assistance, performance optimisation or convenience is not a safety component.
The MDR/IVDR notified body assesses the AI Act requirements as part of its procedure, if it is designated for them.
A single set of technical documentation can cover both regulations.
The quality management system and post-market surveillance can integrate the AI Act elements.
AI Act obligations for Annex I systems apply from 2 August 2028.
A manufacturer outside the EU needs an Authorised Representative under Article 11 MDR/IVDR and, for the high-risk AI system, an authorised representative under Article 22 AI Act. Both can be the same EU company, under mandates covering both regulations. MDR representation is provided on getEAR.eu.
No. It is high-risk under Article 6(1) when the AI is the device or its safety component and the device requires notified body assessment under the MDR or IVDR.
From 2 August 2028, as amended by Regulation (EU) 2026/1744.
No. The AI Act requirements are assessed within the MDR/IVDR conformity assessment by a notified body designated for them.
On getMDR.eu.
On getEAR.eu.
AI Act procedures.
Note: This guide provides general information about Regulation (EU) 2024/1689 (AI Act) as amended by Regulation (EU) 2026/1744 (Digital Omnibus on AI), not legal advice. Last reviewed 5 October 2026.