The recently published MDCG 2025-4 guidance provides important clarifications on how Medical Device Software (MDSW) apps should be made available via online platforms and on the role of these online platforms. With digital distribution channels such as the App Store and Google Play playing a central role in healthcare software deployment, the guidance has significant implications for medical device manufacturers operating in the EU.
In essence, the guidance clarifies that digital distribution does not reduce regulatory obligations. Software-based medical devices must be subject to the same level of regulatory scrutiny and compliance as traditional, physical devices.
We set out below some comments on the distinction between platforms acting as intermediary service providers under the Digital Services Act (DSA) and those that may qualify as importers or distributors under the EU Medical Devices Regulations (the MDR and IVDR).
Placing MDSW on the market and making MDSW available
The MDCG guidance confirms that when a medical device manufacturer uploads an MDSW app to a digital platform, this act constitutes "placing on the market" under MDR/IVDR. Once the app becomes available to users, it is considered "made available on the market."
The guidance also confirms the scope of the regulatory framework, noting that MDSW is not exempt from medical device rules. Before uploading an app, manufacturers must ensure full compliance with applicable MDR/IVDR requirements, including CE marking, labelling, intended purpose, and safety documentation.
The role of the app platform: Intermediary vs. distributor/importer
The guidance distinguishes between platforms acting as intermediary service providers under the DSA and those that may qualify as distributors or importers under MDR/IVDR. This distinction carries significant regulatory implications.
1. Platform hosts third-party apps = Intermediary service provider
Where platforms host third-party apps without taking ownership or modifying the product, they may be considered intermediary service providers under the DSA. For example, the platform may store and disseminate information to the public and allow consumers to conclude contracts with traders. In this case, the platform is not an economic operator in the supply chain under the medical device rules, and the regulatory responsibility remains solely with the manufacturer.
The DSA nonetheless imposes transparency and accountability obligations on these platforms, including mechanisms for illegal content reporting, information accuracy checks, and cooperation with authorities in the case of unsafe or non-compliant products.
2. Platform takes ownership of MDSW and then makes it available to the user = Distributor or importer
Where a platform takes ownership of or receives other rights in the MDSW app from a manufacturer, and then makes it available to EU users, it may be classified as an importer or a distributor. In this case, it is the platform that obtains rights in the MDSW and transfers these rights to the end user, and is therefore an economic operator in the supply chain. Classification as an importer or distributor comes with specific regulatory obligations, including verification of regulatory documentation, cooperation with competent authorities and ensuring MDR/IVDR compliance before distribution. This is a significant burden for platforms.
Transparency considerations
Regardless of the platform's role, the platforms must allow manufacturers to clearly display identifying information, such as the manufacturer's name and address, Single Registration Number (SRN), Unique Device Identification (UDI), intended purpose, warnings or precautions, and links to electronic instructions for use (eIFU). In addition, the guidance encourages platforms to clearly distinguish MDSW apps from health and lifestyle apps.
Next Steps for MDSW manufacturers and platforms
Given the compliance risks involved, manufacturers should engage early with their platform partners to clarify their role (intermediary or distributor/importer). These roles should also be clearly defined in contractual agreements, with the obligations of both parties clearly set out, and contracts with end-users should also be checked to ensure these reflect the roles of the parties. Importantly, manufacturers should anticipate that platforms will need to request more detailed documentation as part of their due diligence, potentially introducing administrative hurdles or delays before MDSW can be made available.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
