Impact of the AI-act on your medical device 

This deadline is not only applicable to new AI-enabled medical devices, but also to AI-enabled medical devices undergoing a substantial modification. Unfortunately, it is not yet exactly known what constitutes a substantial modification under the AI Act but note that it is probably different from a substantial change as defined by the MDR.  

Requirements and preparations

Even though the details are not fully known yet, and only one guideline is available, you should not wait to start preparing for the AI Act. The regulation itself already lays down requirements that need to be fulfilled. Part of this overlaps with requirements that are already known from the MDR, but there are also new requirements. For example, requirements on data governance, transparency, human oversight, automatically generated logs, and fundamental rights. 

Interaction with the Notified Body

Furthermore, the interaction with the Notified Body will change somewhat, as the Notified Body can, under the AI Act, request access to datasets, trained models etc. The manufacturer should be able to enable safe and secure remote access through API or other technical means. 

New guidance document

The new guidance document** makes very clear that conformity assessment of AI-enabled medical devices towards MDR and AI Act should be integrated, requiring one single technical documentation, one single quality management system, and as such also one single conformity assessment, which should cover the additional requirements posed by the AI Act. 

Currently, Kiwa is already certifying AI-enabled medical devices under the MDR, and as such has the expertise to evaluate the AI part already, since the MDR also requires accuracy, robustness and reliability as part of the general safety and performance requirements.

At this moment, even though there have so far been no details from the European authorities on how exactly designation will take place, Kiwa is actively working towards getting designated, by extending competences, procedures and testing facilities for AI Act specific requirements. To make sure we will be able to accept your applications or continue with ongoing applications and already MDR certified AI-enabled medical devices, as soon as we are designated to the AI act.  

* See also C(2025) 5053 final, d.d. 29.7.2025; Commission Guidelines on the definition of an artificial intelligence system established by Regulation (EU) 2024/1689 (AI Act) 

** AIB 2025-1 MDCG 2025-6 Interplay between the Medical Devices Regulation (MDR) & In vitro Diagnostic Medical Devices Regulation (IVDR) and the Artificial Intelligence Act (AIA)