MDCG 2025-04: New EU guidance on ensuring safe distribution of medical device software via online platforms
19 June 2025
On June 16, 2025, the European Commission published the guideline MDCG 2025-4 “Guidance on the safe making available of medical device software (MDSW) apps on online platforms”. This guideline outlines the requirements for the safe provision of software apps classified as medical devices on online platforms: The MDR (EU) 2017/745, the IVDR (EU) 2017/746, and the Digital Services Act (DSA) may then apply to manufacturers of such apps and app platforms.
In the new guideline, the European Commission defines the role of app platforms that provide medical device software apps. There is a distinction between app platform providers acting as intermediary service providers and distributors or importers. In the more passive role of intermediary service provider, the platform merely enables app manufacturers to make their apps available to users. The platform is not considered as an actor under the MDR/IVDR and the DSA applies. These platforms must remove illegal content and provide a transparent user interface. Very Large Online Platforms (VLOPs) must also carry out risk assessment and implement risk mitigation strategies. However, a platform can also take a more active role by directly transferring ownership or other rights to the user and thereby acting as a distributor under MDR/IVDR. In this case, Article 14 MDR/IVDR applies. If the app manufacturer is based outside the EU and the platform operator is based within the EU, the platform operator is considered an importer in accordance with Article 13. In this role of distributor or importer, the platform must ensure the conformity of the apps and cooperate with the authorities, among other things.
The guideline also lists the information that must be provided on the app platforms. This includes information that the manufacturer must provide and that must be visible to the user on the platform, in accordance with Article 31 of the DSA. Clear categories must be defined for the apps and products, such as Medical Device, Health, Lifestyle and Medical. In addition, marking and labeling must comply with MDR/IVDR. Furthermore, the guidance defines information obligations for app platform providers as intermediary service providers. This includes verifying information before publishing apps and conducting risk assessments for large platforms.
The guideline is relevant for manufacturers and platforms as it not only explains the new role of app platforms under DSA and MDR/IVDR, but also clarifies the regulatory requirements and framework conditions for these platforms and outlines how these regulations interact.
