European Commission releases updated MDCG 2019-11 guidance on software qualification and classification under MDR and IVDR
20 June 2025
The European Commission has published an updated version of Guideline MDCG 2019-11 “Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR”. This guidance addresses the classification of medical device software and clarifies whether it is to be considered a medical device or an accessory, determining whether it falls under the Medical Device Regulation (MDR) or the In Vitro Diagnostic Medical Devices Regulation (IVDR). Furthermore, the risk class of the software is determined based on its intended use.
The updated guideline brings important changes and clarifications. The scope of the guideline has been expanded to include software that falls under MDR Annex XVI, i.e. products without a medical purpose. In addition, the necessity of a clear intended purpose is underscored. The guideline also provides a thorough explanation of the handling of modular software, consisting of medical device software and other software, and examines the connection between the MDR requirements and those of the European Health Data Space (EHDS).
New examples illustrate the various software applications. These include software for treatment, therapeutic software with virtual reality (VR) or interactive games, modular software, whereby important modules are non-medical and do not fall under MDR/IVDR, and Class I software.
An explanation and clarification of sub-rule 11a has also been added to classification rule 11.
This revision resolves ambiguities and inconsistencies, making it particularly relevant for medical device software manufacturers. It is crucial that manufacturers understand and apply the updated guidance to meet regulatory requirements.
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