The Revised MDCG 2019‑11: What It Means for SaMD Classification (August 2025)
- Elevate MedTech Partners
- Mar 9
- 2 min read
In August 2025, the EU revised MDCG 2019‑11, the key guidance on how software is classified as a medical device under MDR Rule 11. For digital health and SaMD developers, this update can change risk class and impact the entire regulatory plan.
Why this update matters
MDCG 2019‑11 explains how Rule 11 of MDR Annex VIII applies to software and helps decide whether a product is class IIa, IIb, or III based on its intended purpose and clinical impact. The 2025 revision adds clearer examples and borderline cases, especially for:
Lifestyle/wellness apps vs real medical device software
Clinical decision support tools that influence diagnosis or therapy
Software that drives or influences a device
AI/ML tools that predict or forecast disease or treatment response
For many solutions, this may mean a higher risk class than initially assumed.
Practical implications for SaMD and digital health
Following the revision, manufacturers should:
Recheck intended purpose and claims
Terms like “monitoring”, “diagnosing”, or “supporting treatment decisions” can push software into a higher class, with more demanding evidence and Notified Body involvement.
Review existing classifications
Products previously classed as IIa may now be seen as IIb or III when measured against the updated examples, especially clinical decision support and AI tools.
Align clinical and regulatory strategy
Confirmed risk class affects clinical evaluation depth, PMCF strategy, and the overall submission pathway.
What you can do next
If you develop SaMD or AI‑enabled tools for the EU market, now is the time to:
Map your products against the revised MDCG 2019‑11 examples.
Update intended purpose, labelling and documentation where needed.
Adjust your clinical and risk management strategy to match the final class.
At Elevate MedTech Partners, we help digital health teams interpret MDR software rules and turn them into practical regulatory and clinical plans.
If you’d like to understand how the August 2025 revision of MDCG 2019‑11 affects your roadmap, get in touch and we’ll be happy to explore your specific case.
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