The European Commission (EC) has published MDCG 2025-4, a new guidance document endorsed by the Medical Device Coordination Group (MDCG), offering clarity on how medical device software (MDSW) apps should be made safely available on online platforms. The guidance addresses the obligations of both app platform providers and manufacturers under the Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR), and the Digital Services Act (DSA).
Why This Matters
With more patients using mobile apps for medical purposes, such as diagnostic tools, it's essential that these MDSW apps meet regulatory standards. This guidance ensures safe and transparent distribution of MDSW apps via digital platforms such as app stores and marketplaces.
Key Roles and Responsibilities
App platform providers - two scenarios are outlined for app platforms:
- Intermediary Service Providers (under the DSA):
If the app store hosts apps from external developers (e.g., manufacturers), it acts as an intermediary and must: - Allow users to report illegal content
- Ensure trader (manufacturer) details are visible and accurate
- Comply with risk assessment framework obligations if designated as a Very Large Online Platform
- Distributors or Importers (under MDR/IVDR):
If the app store owns and distributes the app itself, or if it acts on behalf of a third-country manufacturer, it becomes an economic operator and must: - Ensure the app complies with MDR/IVDR
- Cooperate with competent authorities
- Fulfil obligations under Articles 13 or 14 of MDR/IVDR
Required Information on App Platforms
App platform providers are expected to ensure that sufficient product and regulatory information is made available by MDSW manufacturers. This includes relevant technical and compliance details to help users clearly understand the nature of the app and its medical purpose.
The guidance also stresses the importance of distinguishing MDSW apps from general wellness, health, or lifestyle apps, ensuring transparency and avoiding user confusion. Platforms should facilitate visibility of such information in a clear and accessible manner.
Data & Risk Compliance
Platforms must make reasonable efforts to:
- Verify traders' legitimacy before listing apps
- Randomly check online databases for app legality
- Conduct annual risk assessments, especially if classified as Very Large Online Platforms
This guidance plays a pivotal role in ensuring safe access, traceability, and compliance for medical apps across the EU, while balancing regulatory responsibilities between manufacturers and digital platforms.
Official Source: MDCG 2025-4 - Guidance on the safe making available of medical device software (MDSW) apps on online platforms (June 2025)
Published by European Commission on 16 June 2025
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