Introduction
Software Applications (Apps) are significantly changing our way of living, helping in various aspects of our daily lives, including healthcare. Medical device software (MDSW) Apps cover an extensive variety of uses such as those intended to drive insulin pumps, detect and diagnose skin cancers (e.g. melanoma) etc.
These apps are directly available on app platforms for download and use by patients. Their safety and compliance with the safety and performance requirements of the Medical Devices Regulations is paramount. It is therefore of crucial importance that app platform providers enable manufacturers of MDSW to fulfil their requirements including but not limited to the transparency requirements set out in the MDR/IVDR.
This guidance aims to describe the obligations of app platform providers and their respective responsibilities under the MDR/IVDR as well as the Digital Services Act (DSA), which introduces requirements for online intermediary service providers.
In accordance with Article 103 (8) of Regulation (EU) 2017/745 on Medical Devices (MDR) and Article 98 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), this MDCG guidance provides clarifications regarding the role and responsibilities of app platform providers when facilitating the making available of medical device software (MDSW) apps on the Union market. This guidance also provides information regarding information which should be provided by medical device manufacturers when making available their MDSW Apps.
MDCG 2025-4 - Guidance on the safe making available of medical device software (MDSW) apps on online platforms (June 2025)
MDCG 2025-4 - Guidance on the safe making available of medical device software (MDSW) apps on online platforms (June 2025)
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