New MDCG Guidance for the Provision of Medical Apps on Online Platforms

Date

May 12, 2025

Category

EU Regulations

Description

On June 16, 2025, the EU Commission published the "MDCG 2025-4 – Guidelines for the Secure Provision of Medical Device Software (MDSW) Apps on Online Platforms." It provides guidance for the provision of medical device software (MDSW) apps on online platforms and clarifies the regulatory requirements and responsibilities for manufacturers and platform operators.

The guidance should help manufacturers avoid inadvertent violations of regulatory requirements by clarifying the interface between the Medical Device Regulation (MDR) and the Digital Services Act (DSA).

The role of platforms is differentiated between host and economic operator. The goal is to ensure that MDSW offered on online platforms such as the App Store or Google Play comply with both the MDR and DSA requirements. This results in specific information obligations for manufacturers and platform operators.