The Medical Device Coordination Group (MDCG) just published a new guidance on medical device software (MDSW) available on app platforms. Overall, more than one legislative framework can apply to the same product, including MDSW apps. MDCG 2025-4 explains the obligations of app platform providers and their responsibilities under the Medical Devices Regulations (MDR and IVDR) as well as under the Digital Services Act (DSA).
MDSW apps on the Union market: regulatory consideration
The upload of a MDSW app by a manufacturer corresponds to the “placing on the market” (whether in return for payment or free of charge). The time during which the MDSW app is available on the app platform provider corresponds to the “making available on the market”. The app platform provider qualifies as an economic operator in the distribution chain when they make its own MDSW available to users.
First scenario: app platform provider as an intermediary service provider
Based on how an app is made available on the Union market, different scenarios can be analysed. For instance, an app platform provider can act as an intermediary service provider, including as an online marketplace (an online platform allowing consumers to conclude distance contracts with traders) where the product is made available to the user by the manufacturer, importer or distributor. In this case, although the app platform provider does not classify as an economic operator, DSA would still be applicable. Consequently, the app platform providers’ obligations include, among others:
- Notification of illegal content
- Transparency and compliance requirements
- Accountability
Second scenario: app platform providers as distributors or importers
Different obligations apply when the app platform provider classifies as an economic operator. For instance, this is the case when a manufacturer makes a MDSW app available to an app platform provider and the app platform provider makes that app directly available to the user as a distributor or importer (by for example transferring the ownership or other right). In addition, if the manufacturer is based outside of the EU, then the app platform provides acts as importer and the manufacturer must appoint an authorised representative.
According to this scenario, as distributors or importers the platform provider has specific obligations. This includes, but is not limited to:
- Ensuring compliance with the MDR and IVDR
- Cooperation with authorities
Information obligations to provide to patients
MDCG 2025-4 provides also a list of information to supply with the MDSW according to the MDR and IVDR. The list also aims to facilitate the fulfilment of the DSA requirements by app platform providers. The list includes:
- Information to be requested from MDSW manufacturers and available to patients on app platform. This enhances name, address, telephone number and email address of the economic operator, information necessary for identification of the product and the trader, information on labelling and product compliance.
- Clear product categories on app platforms. App platform providers should differentiate between MDSW app and health apps (apps with no intended medical purpose).
- Information concerning the labelling and marking in compliance with rules of the MDR and IVDR. This includes product information, legal compliance information, and operating requirements.
- Information obligations for app platform providers considered as intermediary services providers. App platform providers should conduct regular checks to ensure that apps include the required information. Additionally, Very Large Online Platforms are subject to further obligations under the DSA.
Updated software guidance
In June 2025, the MDCG group updated MDCG 2019-11. This document provides guidance on the qualification and classification of software according to the MDR and IVDR. Among others, the revised version includes more considerations on the intended purpose of MDSW, clarifications on the scope of Annex XVI software, and new examples.
To learn more about MDSW, additional information is available in our Library of Documents. For any questions, contact us here or at mdlaw@obelis.net.
Leave a Reply