Juni 25, 2025
Artificial Intelligence Act Regulatory

Interplay Between MDR, IVDR and AIA

The use of artificial intelligence (AI) in medical technologies is quickly and profoundly changing the healthcare industry. As AI becomes more integrated into medical and in vitro diagnostic devices, establishing clear regulations is becoming increasingly essential. To keep up with these developments, EU regulatory authorities have issued an important new document to guide the process.

 

The main topics covered are: 

Data Governance

Transparency

Accuracy, Robustness, and Cybersecurity

Clinical and Performance Evaluation

Technical Documentation and Post-Market Surveillance


A Living Document

It is important to understand that the MDCG 2025-6 / AIB 2025-1 FAQ is a dynamic document. It represents an ever-evolving collection of answers that will be regularly updated as the implementation of the AIA progresses and practical experience is gained across the industry.


Significance of this Guidance

This document offers important insights for producers on managing compliance in a regulatory landscape that involves multiple frameworks. It also serves as a useful reference for certification bodies and regulatory agencies to coordinate their roles and expectations when evaluating AI-driven products under different regulations.

As the regulatory landscape for AI-powered devices becomes more intricate, it is crucial for stakeholders to begin adjustments early and develop comprehensive strategies to stay ahead.