Guidance MDCG 2025-4, published by the EU Medical Device Coordination Group in June 2025, provides guidance on the safety of medical device software (MDSW) apps on online platforms. An online platform is a hosting service that, at the request of a recipient of the service, stores and disseminates information to the public.
Software applications developed for mobile devices (such as smartphone apps) are significantly changing the way we live, supporting every aspect of our daily lives, including healthcare. Medical device software (MDSW) apps cover a wide range of uses, such as driving insulin pumps and detecting and diagnosing skin cancer (e.g. melanoma).
An online platform is a hosting service that disseminates information to the public. The guidance sets out how software apps on online platforms comply with the MDR and IVDR requirements, in one chart:
This is a series of educational articles introducing FDA, NMPA, GMP, CE MDR/IVDR and MDSAP regulations and standards. We are happy to share medical device expertise with industry clients and hope our extensive hands-on experience in quality systems and product registration will be of help to you. Let’s contribute together to the development of the medical device industry.
More articles:
China NMPA Registration: Applying Real-World Data in Clinical Evaluation of Medical Devices
Detailed Guide to the Medical Device Classification Determination Procedure
The Complete Australian Medical Device Registration Process Explained
