EC | Revised Guidance on Qualification and Classification of Software Under MDR & IVDR (MDCG 2019-11 Rev.1)

Syafina Y. July 04, 2025
On 17 June 2025, the European Commission (EC) released MDCG 2019-11 Rev.1, a key update to the existing guidance on the qualification and classification of software under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

This document is a critical reference for manufacturers of Medical Device Software (MDSW), including applications that run on mobile, cloud, or other platforms. The guidance clarifies when software qualifies as a medical device and how it should be classified under applicable EU regulations. Importantly, this update also provides new examples and clarifies the regulatory expectations for software modules, Annex XVI products, and Artificial Intelligence (AI)-enabled software.

Terminology Update: "Standalone Software" No Longer Used

The term “standalone software”, previously used under the Medical Devices Directives, is no longer applicable under the MDR and IVDR. This change reflects the regulatory shift to qualify and classify software solely based on its intended purpose, regardless of where or how it operates, be it embedded, cloud-based, mobile, or platform-hosted.

This ensures consistent interpretation across all deployment environments and simplifies regulatory classification logic.

Key Revisions in MDCG 2019-11 Rev.1 (June 2025)

The table below highlights the main updates introduced in the revised guidance:

Section
Key Revision Summary
1
Scope clarification
3
Added importance of clearly defining intended purpose; references to modular MDSW introduced
3.1
Clarified scope for Annex XVI software
3.2
New examples added, including MDSW intended to treat
4.2.1
Clarified Rule 11 (Subrule a); added references and examples for devices intended for illness prevention
7
Expanded elaboration on Modules
Annex I (c.1)
Now includes reference to the European Health Data Space Regulation for Electronic Health Record Systems (EHR)
Annex IV
Added a new Class I example

This updated guidance supports more consistent qualification and classification decisions and is aligned with the evolving landscape of digital health technologies. Manufacturers are encouraged to review the full document for implementation details:

Published by European Commission on 17 June 2025