AI-Medical Device software compliance requirements map

This document referrers to the preliminary assessment of the Medical Device Regulation (MDR)1 and the Artificial Intelligence Act (AIA) proposal2 in relation to AI-Mind. “AI-Mind” refers to the AI-Mind connector and predictor tools.

The MDR is a new set of regulations that governs the production and distribution of medical devices in Europe. Compliance with the MDR is mandatory for medical device companies that want to put their products in the European marketplace. The MDR represents brand new regulations with a lot of changes from the previous Medical Device Directive (MDD) and replaced the MDD as of May 2021. The AIA is the European Commission’s proposal of harmonised rules regarding AI applications, published on 21st April 2021. The goal is to regulate the use of AI and promote it by imposing extensive documentation, training, and monitoring requirements. Any company in the EU market will be affected by the AIA. Based on a preliminary assessment, our hypothesis is that AI-Mind will most likely be considered a class IIa medical device and a high-risk AI system