On 19 June 2025 the MDCG released a comprehensive FAQ on the interplay between the Medical Devices Regulation & In vitro Diagnostic Medical Devices Regulation and the Artificial Intelligence Act
This publication aims to address common inquiries concerning the integration and application of the AI Act alongside existing medical device regulations within the European Union. The document serves as a guide for stakeholders to navigate the regulatory landscape and ensure compliance with the evolving legislative framework.
Key takeaways include:
High‑risk classification: Under AIA Article 6(1), an AI system is classed as high-risk if it's a safety component or a medical device subject to conformity assessment under MDR/IVDR—but this doesn’t change the device’s risk class under MDR/IVDR.
Terminology alignment: “Manufacturer” in MDR/IVDR equates to “provider” in AIA, while “deployer” in AIA is not the same as “user” under MDR/IVDR.
Quality management & risk lifecycle: It encourages integrating AIA-specific data governance, transparency, human oversight, and lifecycle surveillance into existing MDR/IVDR QMS.
Technical documentation & post‑market monitoring: A single coherent technical file is recommended that satisfies both MDR/IVDR and AIA requirements, including AI-specific oversight and ecosystem interaction risks.
This “living document” will evolve with more FAQs as new regulatory challenges emerge.
Download the full document.
