MDCG Guidance for Medical Device Software Apps Available Through Online Platforms

New EU guidance recently issued by the Medical Device Coordination Group examines the potential obligations of online platforms that offer software medical device apps to users in the EU. The guidance addresses relevant requirements under the MDR, IVDR as well as the Digital Services Act. Our Life Sciences team reviews the key aspects of the guidance, including the classification of app platform providers under EU law, and their resulting responsibilities.

What you need to know

• New EU guidance clarifies obligations linked to the supply of medical device software apps in the EU using online platforms.
• These platforms can be subject to requirements as ‘intermediary services’ under the DSA or as ‘distributors’ or ’importers’ under the MDR or IVDR, in certain circumstances.

Medical device software (MDSW) apps supplied through online platforms are an increasingly common feature of the EU digital health landscape. The Medical Device Coordination Group (MDCG) has now released a new guidance document, entitled 'Guidance on the safe making available of medical device software (MDSW) apps on online platforms' (MDCG 2025-4), intended to provide clarity for ‘app platform providers’ and other stakeholders under:

• The EU Medical Device Regulation (MDR),
• The EU In Vitro Medical Device Regulation (IVDR), and
• The EU Digital Services Act (DSA).

The Guidance focuses on two key issues:

1. The potential obligations and responsibilities of app platform providers involved in the supply of MDSW apps in the EU
2. The product information that should be provided by manufacturers when making their MDSW apps available using app platforms

Categorising App Platform Providers

The guidance identifies two possible roles of app platform providers involved in the supply of MDSW:

a. App Platform Providers as Intermediary Service Providers under the DSA

Where the provider of an app platform qualifies as an intermediary service provider under the DSA, the guidance confirms that this does not necessarily trigger status of the app platform provider as an economic operator under the MDR, but DSA rules will still apply.

b. ‘App Platform Providers’ as Distributors or Importers under the MDR

Where a legal manufacturer makes its MDSW app available to an app platform provider (i.e. transfers an ownership or other right), and that app platform provider in turn makes that MDSW app available (i.e. transfers an ownership or other right) to a device user, the guidance confirms that this would qualify the app platform provider in this scenario as either an importer or a distributor of the MDSW app under the MDR.

The guidance provides no further insights from the MDCG as to how the transfer of ownership, possession or any other right (excluding intellectual property rights), as described in the EU Commission Blue Guide, should be interpreted in the context of the supply of MDSW apps. Seeing as this is not a settled area, and this question is central to the status of app platform providers under the MDR, this will be viewed as a missed opportunity by many stakeholders.

Information requirements

The guidance does provide some useful clarification on what constitutes the “information concerning the labelling and marking in compliance with rules of applicable Union law on product safety and product compliance” under the DSA, in the context of the MDR and IVDR specifically.

In the case of medical devices and IVDs the guidance states that this information includes:

• The MD or IVD symbol indication
• A clear description of the device and its intended purpose
• Warnings or precautions to be taken that need to be brought to the immediate attention of the user
• A link to the IFU
• The Unique Device Identification (UDI-DI) number

And (where applicable):

• The name and address of the authorised representative
• The notified body number
• The EU certificate number
• Any particular operating instructions for the device
• Information on whether a hardware device available from the manufacturer is also required for use as part of the device or accessories
• Minimum requirements for hardware, setup and connection and security.

The guidance also recommends that app platform providers create a clear delineation in their app libraries between MDSW apps and lifestyle/wellness apps that are not regulated as medical devices or IVDs.

Conclusion

This guidance sets out key considerations for the supply of MDSW apps through online platforms, including app stores. It highlights how these app platform providers must carefully assess their specific role – and their possible status as an intermediary service provider under the DSA, or an economic operator under the MDR or IVDR – in order to understand their regulatory obligations. MDSW manufacturers must also provide all necessary product information when supplying their devices via app platforms, and the guidance provides some helpful clarifications as to what information is required in this context

For more information, contact a member of our Life Sciences team.

The content of this article is provided for information purposes only and does not constitute legal or other advice.