The MDCG has released a new guidance relating to safe making available of medical device software (MDSW) apps on online platforms. To offer some background to this guidance, Software Applications (Apps) are transforming the way we live, playing an increasingly important role in various aspects of our daily lives, including healthcare. Among these are Medical Device Software (MDSW) apps, which serve a wide range of purposes—from controlling insulin pumps to detecting and diagnosing conditions such as melanoma.
These apps are often made directly available to patients via app platforms. As such, ensuring their safety and compliance with the relevant Medical Devices Regulations is critical. It is therefore essential that app platform providers support MDSW manufacturers in meeting their regulatory obligations, including the transparency requirements outlined in the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR).
This guidance document outlines the responsibilities of app platform providers under the MDR/IVDR, as well as under the Digital Services Act (DSA), which sets out additional requirements for online intermediary service providers.
Pursuant to 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 guidance—issued by the Medical Device Coordination Group (MDCG)—provides clarification on the role and obligations of app platform providers in enabling the availability of MDSW apps in the EU market. It also outlines the information that medical device manufacturers must provide when offering their MDSW apps to users.
The guidance document can be accessed using the following link
