The MDCG has released a guidance document concerning the interplay between the Medical Devices Regulation (MDR) & In vitro Diagnostic Medical Devices Regulation (IVDR) and the Artificial Intelligence Act (AIA).
This document offers an initial set of answers to the most frequently asked questions concerning the joint application of the Artificial Intelligence Act (AIA) and the Medical Devices Regulation (MDR) or In Vitro Diagnostic Medical Devices Regulation (IVDR). These FAQs will be continuously developed and updated. The primary audience includes — but is not limited to — medical device manufacturers, notified bodies, and competent authorities.
Throughout this document, the term ‘manufacturer’ as defined in the MDR/IVDR should be interpreted as equivalent to ‘provider’ under the AIA. The term ‘deployer’, as defined in Article 3(4) of the AIA, refers to any natural or legal person, public authority, agency, or other body that uses AI systems under its authority, except where the use is for personal, non-professional purposes. It is important to note that the AIA does not define the term ‘user’ — which in the context of the MDR/IVDR refers to any healthcare professional or layperson using a device. Therefore, the term ‘deployer’ under the AIA should not be considered synonymous with ‘user’ under the MDR/IVDR.
While the MDR and IVDR address risks associated with medical device software, they do not explicitly cover risks unique to AI systems. The AIA complements these regulations by introducing specific requirements to address AI-related hazards and risks to health, safety, and fundamental rights. Under the New Legislative Framework, this results in a simultaneous and complementary application of the AIA alongside the MDR or IVDR for medical devices incorporating one or more high-risk AI systems.
For the purposes of this document, AI systems used for medical purposes are referred to as Medical Device Artificial Intelligence (MDAI). All references to MDAI are understood to include not only medical devices covered by the MDR but also products listed under MDR Annex XVI, accessories to medical devices, in vitro diagnostic medical devices, and their accessories.
This guidance is issued without prejudice to any further guidance that may be adopted by the European Commission based on the AIA.
To ensure consistency, reduce duplication, and minimise administrative burden, MDAI manufacturers — in accordance with Article 8(2) of the AIA — are encouraged to integrate, where appropriate, the required testing, reporting, information, and documentation into their existing MDR/IVDR compliance systems. While manufacturers are encouraged to make use of this flexibility, they must still ensure full compliance with all applicable requirements under the AIA, MDR or IVDR, and any other relevant Union legislation.
The guidance document can be accessed using the following link
