MDCG 2019-11 Rev.1 - New guidance on qualification and classification of software as a medical device or in vitro diagnostic medical device

The Medical Device Coordination Group (MDCG) published revision 1 of guidance document MDCG 2019-11, which addresses the qualification and classification of software under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR).

This document, aimed primarily at manufacturers of Medical Device Software (MDSW), provides a detailed overview of:

• Criteria for determining whether software qualifies as a medical device or an in vitro diagnostic medical device (IVD);

• Application of classification rules to MDSW, including software with artificial intelligence (MDAI);

• Considerations regarding placing software on the market and conformity assessment, whether as a standalone device or in combination with hardware;

• The importance of clearly defining the intended purpose of the software, essential to ensure compliance and safety.

The revised version (June 2025) introduces relevant clarifications, such as:

• Clarification of scope, including Annex XVI software;

• New examples of MDSW, including software with therapeutic purposes;

• Updated guidance on modules and modular software;

• Alignment with the European Health Data Space (EHDS) Regulation for electronic health record (EHR) systems;

• Inclusion of new examples of software classification;

• Update and expansion of the application of MDR Rule 11.

This revised document provides practical guidance, helping manufacturers ensure a consistent and robust approach to the development and classification of software in the healthcare sector — an increasing necessity with the rise of digital and AI-based solutions.

Although the original text dates back to 2019, the 2025 update is a valuable addition for the sector, clarifying aspects that have significantly evolved with technological development and new regulations, such as the AI Act and the EHDS.

Access the document below.