Medical Device Coordination Group (MDCG) updates – April to June 2025

DateGuidance NoAbout the guidance
19 Jun 2025MDCG 2025-6FAQ on Interplay between the Medical Devices Regulation & In vitro Diagnostic Medical Devices Regulation and the Artificial Intelligence Act (June 2025)

This document provides a first set of answers, that will be continuously developed and updated, to the most frequently asked questions related to the joint application of the AIA and the MDR or IVDR4
for manufacturers.

This Frequently Asked Questions (FAQ) document is primarily aimed at (but not limited to) medical device manufacturers, notified bodies and competent authorities.

All references to ‘manufacturer’ within the meaning of the MDR/IVDR should be understood as references to ‘provider’ in accordance with the AIA. ‘

Deployer’ defined in the Article 3(4) AIA as a natural or legal person, public authority, agency or other body using AI systems under their authority, unless the use is for a personal non-professional activity.

The AIA does not define the concept of ‘user’ which is defined in the
MDR/IVDR as any healthcare professional or lay person who uses a device. Therefore, the concept of ‘deployer’ under AIA cannot be understood as referring to ‘user’ under MDR/IVDR.

For the purposes of this document, AI systems used for medical purposes are referred to as Medical Device Artificial Intelligence (MDAI).
18 Jun 2025MDCG 2025-5Questions & Answers regarding performance studies of in vitro diagnostic medical devices under regulation (EU) 2017/746 (June 2025)

This document is intended for sponsors of performance studies of in vitro diagnostic medical devices (IVDs) conducted within the scope of the Regulation (EU) 2017/746 (IVDR).

It also contains information of relevance to manufacturers providing IVDs for use in performance studies that may be sponsored by other actors, and sponsors of combined studies
17 Jun 2025Update MDCG 2019-11 rev.1Qualification and classification of software – Regulation (EU) 2017/745 and Regulation (EU) 2017/746 (June 2025)

This document, which primarily targets Medical Device Software (MDSW) manufacturers, provides guidance on:
• the criteria for the qualification of software falling within the scope of the Medical Device Regulations including Medical Device Artificial Intelligence (MDAI)
• the application of the classification criteria under those regulations to MDSW and
• information related to placing on the market MDSW.

The revision 1 changes are listed on page 1 of the updated document.

Further reading
Revised guidance on classification of Medical Device Software in the EU by Jackie Mulryne et al, 8 July 2025, Arnold & Porter
16 Jun 2025MDCG 2025-4Guidance on the safe making available of medical device software (MDSW) apps on online platforms (June 2025)

This guidance aims to describe the obligations of app platform providers and their respective responsibilities under the MDR/IVDR as well as the Digital Services Act (DSA), which introduces requirements for online intermediary service providers.

In accordance with Article 103 (8) of Regulation (EU) 2017/745 on Medical Devices (MDR) and Article 98 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), this MDCG guidance provides clarifications regarding the role and responsibilities of app platform providers when facilitating the making available of medical device software (MDSW) apps on the Union market.

This guidance also provides information regarding information which should be provided by medical device manufacturers when making available their MDSW Apps.

Further reading
EU Medical Device Software: New guidance on placing software medical devices on the EU market by Jackie Mulryne et al, 20 June 2025, Arnold & Porter.