The European Commission unveiled its latest guidance on June 16, 2025, aimed at enhancing the safety and compliance of medical device software (MDSW) apps available on online platforms. This move responds to the growing reliance on digital health solutions by patients and healthcare professionals across the EU, ensuring that these applications meet stringent regulatory standards before reaching the market.
Regulatory Framework Integration
The new guidance, designated as MDCG 2025-4, outlines the specific responsibilities of online platform providers under the European Medical Devices Regulation (MDR) 2017/745, the In-vitro Diagnostic Medical Device Regulation (IVDR) 2017/746, and the Digital Services Act (DSA). It clarifies how these regulations overlap and which provisions take precedence, particularly emphasizing the DSA’s Article 6 on liability exemptions and Article 8 on non-general monitoring obligations. Platform providers are now required to implement mechanisms to swiftly address and remove illegal content related to MDSW, ensuring continuous compliance with EU standards.
Responsibilities of Online Platforms
Platform providers like the Apple App Store and Google Play Store must categorize themselves as importers or distributors based on the manufacturer’s location, either within the EU or from third countries. This classification dictates their compliance requirements, including cooperation with competent authorities and adherence to transparency mandates similar to those outlined in the MDR and IVDR. Additionally, large platforms designated by the EC must adopt risk assessment frameworks to mitigate the dissemination of illegal or non-compliant MDSW content.
• Ensuring real-time monitoring and swift removal of illegal MDSW content
• Adhering to transparency requirements for instructions and safety warnings
• Collaborating closely with EU competent authorities and the EC
• Implementing robust risk assessment frameworks for large platforms
• Differentiating roles based on the manufacturer’s geographical location
These measures signify a robust approach to harmonizing digital health solutions with EU regulatory standards, ultimately fostering a safer digital environment for healthcare applications.
As digital health continues to evolve, the European Commission’s guidance marks a critical step in safeguarding patient and professional use of medical apps. By establishing clear responsibilities for platform providers and ensuring rigorous compliance with existing regulations, the EC is setting a high benchmark for the quality and safety of medical software within the Union. This initiative not only protects end-users but also supports manufacturers in navigating the complex regulatory landscape, promoting innovation while maintaining stringent safety standards. Stakeholders in the digital health sector should closely monitor these developments to ensure their products and services align with the new requirements, fostering trust and reliability in the rapidly expanding market of medical device software.
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