Revised MDCG 2019-11 guidance: updated approach to qualification and classification of medical software

Since its initial release in 2019, MDCG 2019-11 has served as the cornerstone for interpreting how software should be qualified and classified under the Medical Device Regulation (MDR). However, the exponential rise of AI-driven tools, interoperable systems, and cloud-based solutions exposed gaps in the original guidance. The 2025 revision addresses these gaps and delivers a more structured and detailed decision-making framework.

Contextualising the 2025 update: why a revision was necessary

From general principles to targeted interpretation: what’s new in the 2025 version?

Compared to the original version, the updated MDCG 2019-11 introduces:

expanded decision trees for determining software qualification,
clarification of borderline cases involving wellness apps and decision-support tools,
guidance on modular MDSW and compound functionalities,
deeper alignment with Rule 11 of Annex VIII MDR,
and references to the EHDS (European Health Data Space) and IMDRF classification criteria.

Importantly, the update reflects learnings from four years of notified body audits and EU-wide consultations.

The intended purpose of SaMD and its regulatory implications

One of the most critical aspects reinforced in the revision is the formulation of the intended purpose. A vague or overly broad statement may result in:

misclassification of the software,
increased scrutiny during conformity assessment,
or delayed market access due to unclear clinical benefit.

The guidance urges manufacturers to provide precise, measurable, and testable intended purposes — particularly for diagnostic and predictive MDSW.

Reinterpreting Rule 11: clinical risk and software logic

The document expands Rule 11 interpretation by introducing a risk-scaling approach. It encourages consideration of:

the software’s level of autonomy in decision-making,
its role in primary vs. supportive diagnosis,
the severity of potential harm from errors,
and whether human intervention is assumed or bypassed.

This allows for better alignment between the software’s functionality and its risk class — ensuring proportionate regulatory control.

Implications for manufacturers and notified bodies

For manufacturers, this update means:

revisiting classification justifications for existing MDSW portfolios,
enhancing risk management files and clinical evaluation plans,
and aligning documentation with latest MDCG expectations.

For notified bodies, it provides a more consistent framework to assess borderline and emerging software categories — improving harmonisation across Member States.

Ultimately, the revised MDCG 2019-11 offers a forward-looking lens into how the EU envisions regulating software not just today, but in the evolving digital health landscape of tomorrow.