June 24, 2025

Medical device software apps: what are the EU compliance requirements?

Written by: Manuel Mateos CEO and Regulatory Affairs Director, CMC Medical Devices & Drugs S.L.

To legally publish a medical device software (MDSW) app in the EU, manufacturers must ensure full compliance with the MDR or IVDR before making the app available on a platform. This includes providing mandatory product information and aligning with MDCG 2025-4 and the Digital Services Act (DSA).

Medical device software (MDSW) apps are transforming healthcare delivery across the EU. But while the technology evolves rapidly, regulatory requirements continue to tighten, especially when apps are made available on digital platforms like app stores.

With the release of MDCG 2025-4, the European Medical Device Coordination Group clarifies the obligations for manufacturers of MDSW under the MDR, IVDR, and Digital Services Act (DSA). Here’s what you need to know.

Table of Contents

When is a medical device software app considered placed on the EU market?

If you upload a MDSW app to an online platform that act is considered placing the product on the EU market.

Even if the app is free, this step marks the point at which full compliance with MDR or IVDR is required. The app must meet all regulatory, safety, and information standards before it becomes accessible to users.

What information must be provided on the platform?

To comply with EU law, manufacturers must ensure that key product information is displayed clearly and accessibly on the app platform. This includes:

Name and contact details of the manufacturer
MD or IVD symbol
Unique Device Identifier (UDI-DI)
Intended purpose of the app
Warnings or precautions
Link to electronic instructions for use (eIFU)
Single Registration Number (SRN)
Name and address of the authorised representative (if applicable)
Notified body number and CE certificate (if applicable)

Platforms must be structured to allow this information to be shown in a consistent and user-friendly way.

Are app platforms considered distributors or intermediaries?

This depends on how the platform is involved in making the app available.

App platform as intermediary (under the DSA)

If the platform only hosts third-party MDSW apps, acting as a neutral intermediary between manufacturers and users, it falls under the DSA as a hosting service or online platform. In this case, it is not considered an economic operator (like a distributor or importer).

Even so, these platforms must:

allow national authorities to issue takedown orders for non-compliant apps
enable traders to present product information as required by EU law
conduct risk assessments if classified as Very Large Online Platforms (VLOPs)

App platform as distributor or importer

If the platform takes part in placing the app on the market, for example, by taking ownership, distributing directly, or acting as an EU-based channel for a non-EU manufacturer, it is considered a distributor or importer under the MDR/IVDR.

This means it is directly responsible for:

verifying compliance of the app
cooperating with EU competent authorities
ensuring that appropriate documentation is available

What do manufacturers need to know about MDCG 2025-4?

This new guidance document brings much-needed clarity to the intersection between medical device law and digital platforms. It highlights the shared responsibility between manufacturers and platforms to ensure that MDSW apps meet all legal requirements before being offered to EU users.

As a manufacturer, you cannot assume that compliance ends after development. You must also:

Validate how your app is presented on each platform
Ensure your economic operators are properly documented
Monitor your listings for completeness and accuracy

Whether you’re developing a new MDSW app or updating an existing one, MDCG 2025-4 is a reminder that market access in the EU is tightly regulated and increasingly digital.