A closer look at MDCG 2025-4 guidance for medical software apps

In June 2025, the Medical Device Coordination Group (MDCG) issued guidance document MDCG 2025-4, a pivotal development for digital health regulation in the European Union. This guidance responds to the growing prevalence of medical device software (MDSW) apps released through online platforms. The framework addresses patient safety, regulatory compliance and transparency obligations related to MDSW apps and their distribution channels.

MDCG 2025-4 applies in the context of several overlapping EU legal instruments: the Medical Devices Regulation (MDR), the In Vitro Diagnostic Medical Device Regulation (IVDR) and the Digital Services Act (DSA). The guidance clarifies that entities providing MDSW apps may be subject to requirements as intermediary service providers under DSA, or as distributors/importers under MDR/IVDR, depending on how the apps are offered to users.

App platform providers: Intermediaries or Economic Operators?
MDCG 2025-4 identifies two primary scenarios for digital platforms hosting MDSW apps:

• Intermediary service providers under DSA: When a platform acts solely as a neutral intermediary, connecting manufacturers with consumers without exerting control over the product, it is considered a service intermediary. Such platforms are not classified as distributors or importers. However, they must implement mechanisms for transparency, report and remove non-compliant or illegal apps, and facilitate compliance information flow.

• Distributors or importers under MDR/IVDR: If platforms actively provide MDSW apps directly to users, such as by transferring ownership or rights, they assume the role of distributor or importer and must comply with the relevant MDR/IVDR obligations. These include verifying compliance, ensuring safety and performance standards, and cooperating with competent authorities, especially if the manufacturer is based outside of the EU.

Information requirements
The guidance reiterates that manufacturers bear ultimate responsibility for ensuring that their software fulfils all MDR/IVDR requirements regardless of distribution method. Manufacturers must supply clear, comprehensive data to platforms, including product identity, regulatory marking, intended purpose, warnings and instructions for use. This information should be readily accessible to end-users via the platform interface.

To prevent confusion among users, MDCG 2025-4 strongly recommends that platforms distinctly categorise medical device software apps separately from health and lifestyle applications with no intended medical purpose. Such classification helps to ensure that users can readily identify certified medical devices, and reduces risks arising from misinterpretation of app purposes. Only apps that meet applicable regulatory requirements and provide key compliance data should be labelled as medical devices.

Conclusion
MDCG 2025-4 offers clarity by defining the shared responsibilities of manufacturers and digital platform providers in distributing MDSW apps. By aligning MDR/IVDR requirements with DSA, the guidance supports patient safety and enhances regulatory compliance. To software developers and platform operators, understanding and implementing these provisions is critical in terms of successful market access and sustained compliance in the expanding EU digital health sector. Do not hesitate to contact us for guidance through the regulations!