MDCG Guidance on the Safe Making Available of Medical Device Software (MDSW) Apps on Online Platforms
The Medical Device Coordination Group (MDCG) has published MDCG 2025-4, which provides guidance on the safe making available of medical device software (MDSW) apps on online platforms. Underlining that compliance of medical device software apps with the safety and performance requirements of the Medical Devices Regulations is paramount and recognizing that medical device software apps can be directly available on app platforms for download and use by patients, the Guidance imposes obligations on app platform providers to enable manufacturers of MDSW to fulfil their related regulatory obligations.
The obligations that operators of online operators are required to fulfil depend on the role of the platform.
Where an online platform is considered to be an "intermediary service" provider, they are considered to be one of the following:
a "mere conduit" communication service transmitting information provided by a recipient of the service or, providing access to a communication network;
a "caching" communication service which transmits information from a recipient of the service through automatic, intermediate, and temporary storage solely for the purpose of making onward transmission of the information to other recipients more efficient; or
a "hosting" service whereby information provided by or at the request of a recipient of the service is stored.
An "online platform" is a hosting service that, at the request of a recipient of services, stores and disseminates information to the public and, for objective and technical reasons, cannot be used without that service. Moreover, the integration of the feature or functionality into the other service is not a means to circumvent applicability of the Regulation.
The Guidance confirms that uploading of a MDSW app onto a platform by a manufacturer constitutes the "placing on the market" of the software. During the time that the app is available via the platform, this constitutes "making available on the market" of the app, i.e., any supply of the app in a commercial activity, whether in return for payment or free of charge.
Where the app made available is the platform's own app the platform provider is considered to be an economic operator in the distribution chain of the medical device;
Where the app platform provider offers only third party MDSW it is considered only as an intermediate service between the app manufacturer and the user or patient who downloads the app.
Where an app platform is an intermediate service that includes an online marketplace, it is not considered to be either a distributor or an importer and, consequently, is not an economic operator. However, overarching provisions of Regulation (EU) 2022/2065 (the Digital Services Act) such as liability exemption and non-general monitoring obligations apply.
Where an app platform permits the conclusion of distance contracts with manufacturers, they must respect obligations that include, but are not limited to:
Notification of illegal content;
Transparency and compliance requirements; and
Where a manufacturer makes a MDSW commercially available on an app platform and the platform then makes the app directly available to the user as a distributor, then the provisions of the Medical Devices Regulation (MDR) and the in vitro diagnostics Regulation (IVDR) governing distributor obligations apply. Where the app manufacturer is from a third country, the platform must undertake the obligations of an importer provided in the Regulations. These include the obligations to:
Ensure compliance with the MDR and IVDR, including with provisions governing safety and performance and data protection; and
Cooperation with authorities.
The Guidance includes details concerning the information that the app platform must request from MDSW manufacturer and the information that must be made available to patients.