MDCG 2025-4: new guidance for the secure provision of MDSW apps on online platforms

In June 2025, the Medical Device Coordination Group (MDCG) published document MDCG 2025-4, a guidance that outlines the responsibilities and obligations related to the provision of software as a medical device (Medical Device Software – MDSW) on digital platforms.

With the exponential growth of health apps—many of which qualify as medical devices or in vitro diagnostic devices (IVDs)—it is essential to ensure that their availability on online platforms complies with the regulatory requirements of Regulation (EU) 2017/745 (MDR), Regulation (EU) 2017/746 (IVDR), and the Digital Services Act (DSA).

Regulatory Framework

The new guidance clarifies the responsibilities of both MDSW manufacturers and platform operators (app stores) that make such software available to end users in the EU market. Key points include:

• Distinction between platforms acting as intermediaries (under the DSA) and those considered distributors or importers under MDR/IVDR

• Mandatory information requirements on platforms — including labeling, CE marking, UDI-DI, and other critical data

• Clarification of compliance responsibilities, cooperation with authorities, and management of illegal content

• Enhanced role of Very Large Online Platforms, which are subject to risk assessments and reinforced obligations under the DSA

Labeling and Information Requirements

To ensure users and patients can clearly identify apps that are medical devices (versus wellness or lifestyle apps), the MDCG recommends that platforms:

• Implement visible and well-differentiated categories

• Ensure MDSW manufacturers provide information such as:

  • Name and function of the device

  • Name and contact details of the manufacturer and authorized representative (if applicable)

  • UDI-DI number

  • Warnings and precautions

  • Information on required hardware or technical specifications

Implications for Manufacturers and Platforms

With this guidance, the MDCG aims to strengthen the safety, traceability, and regulatory compliance of MDSW apps in the European digital market. It is essential that:

• MDSW manufacturers offering apps on online platforms review their compliance practices and documentation

• App store operators with a presence in the EU adjust their policies and controls to ensure they do not promote or distribute non-compliant apps

If you are planning to offer software as a medical device in the EU, or if you manage an online platform with health apps, contact us.

Access the full document below.