European Union: European Commission issued guidance on making available of medical device software apps on online platforms clarifying obligations under Digital Services Act

On 16 June 2025, the European Commission issued guidance on making available of medical device software apps on online platforms, clarifying obligations under the Digital Services Act. The guidance addresses the regulatory obligations for app platform providers distributing medical device software (MDSW) apps in the European Union. The document clarifies how both the Medical Device Regulation (MDR) and the Digital Services Act (DSA) apply to these platforms. The guidance establishes two primary regulatory frameworks depending on the platform's role. When app platforms act as intermediary service providers under the DSA, they facilitate connections between MDSW manufacturers and patients without becoming economic operators themselves. In this capacity, they must implement notice and action mechanisms for illegal content, ensure their interfaces enable manufacturers to comply with transparency requirements, and maintain reliable trader information. Very Large Online Platforms face additional obligations, including risk assessments and mitigation measures. Alternatively, when app platforms directly distribute MDSW apps by transferring ownership or rights to users, they qualify as distributors or importers under the MDR. The classification subjects them to additional requirements, including ensuring app compliance with safety and performance standards, cooperating with competent authorities, and maintaining comprehensive documentation. EU-based platforms distributing apps from third-country manufacturers assume importer responsibilities. The guidance notes that platforms must ensure MDSW manufacturers provide details, including company information, device identification, regulatory compliance data, and safety warnings. The guidance recommends creating clear product categories to distinguish medical device apps from general health applications, helping patients identify regulated medical software.