MDCG 2025-4: Key Guidance for Medical Device Software on Online Platforms

Understanding the Regulatory Landscape

MDCG 2025-4 operates within the framework of the Medical Devices Regulation (MDR), In Vitro Diagnostic Medical Devices Regulation (IVDR), and the Digital Services Act (DSA). It clarifies that multiple EU legal acts can apply concurrently to a single MDSW product. The guidance distinguishes between "placing on the market" (initial introduction by the manufacturer) and "making available on the market" (ongoing accessibility via app platforms).

Roles of App Platform Providers

The guidance outlines two primary roles for app platform providers, each with distinct regulatory implications:

1. Intermediary Service Provider under the DSA

If an app platform solely facilitates the connection between MDSW manufacturers and patients, acting as an online marketplace, it is generally considered an intermediary service provider under the DSA. In this scenario, the platform is typically not classified as a distributor or importer under the MDR/IVDR. However, even as an intermediary, platforms have significant obligations under the DSA, including:

• Notice and Action Mechanisms: Implementing procedures for reporting and addressing illegal content, including non-compliant or unsafe medical device-related content.
• Transparency: Ensuring their online interface allows manufacturers to provide essential product safety and compliance information, and making efforts to verify trader information.
• Accountability: Very Large Online Platforms (VLOPs) must conduct risk assessments regarding the dissemination of illegal content and implement mitigation measures.

2. Distributor or Importer under MDR/IVDR

An app platform provider assumes the role of a distributor or importer if it directly makes a MDSW app available to the user (e.g., by transferring ownership) after receiving it from the manufacturer. This applies regardless of whether the activity is commercial or non-commercial. If the manufacturer is based outside the EU and the app platform is EU-based, the platform acts as an importer.

In these cases, the DSA does not apply. Instead, the app platform provider is subject to the specific requirements of the MDR/IVDR, including:

• Ensuring Compliance: Verifying that MDSW apps meet MDR/IVDR requirements for safety, performance, and data protection.
• Cooperation with Authorities: Collaborating with competent authorities and providing relevant documentation.

Key Information Obligations

The guidance emphasizes transparency and clear information provision. App platforms must ensure manufacturers can provide comprehensive details, including contact information, clear product identification, and branding.

Crucially, the MDCG 2025-4 recommends that app platforms create a distinct category for MDSW apps, separate from general health or lifestyle apps. This helps users unambiguously identify regulated medical devices. Manufacturers must provide specific labeling and marking information in compliance with MDR/IVDR, such as device name, manufacturer details (including SRN), MD/IVD symbols, intended purpose, warnings, eIFU links, and UDI-DI.

Conclusion

MDCG 2025-4 provides essential clarity for the evolving landscape of MDSW apps on online platforms. It highlights the dual regulatory responsibilities under the MDR/IVDR and DSA, urging all stakeholders to understand their specific roles and obligations. Adherence to this guidance is vital for ensuring patient safety, maintaining regulatory compliance, and fostering trust in digital health solutions within the EU.

Reference

European Commission. (2025, June). MDCG 2025-4 - Guidance on the safe making available of medical device software (MDSW) apps on online platforms. Retrieved from https://health.ec.europa.eu/latest-updates/mdcg-2025-4-guidance-safe-making-available-medical-device-software-mdsw-apps-online-platforms-june-2025-06-16_en