[Emergo, UL] European Commission issues guidance on making safer apps available

In our daily lives and also in the medical field, patients and healthcare professionals are increasingly using apps. On June 16, the European Commission (EC) published “MDCG 2025-4 Guidance on the safe making available of medical device software (MDSW) apps on online platforms.”

 

While the EC has published several pieces of guidance on MDSW already (our next update will be on the MDCG 2019-11 revision), this guidance is aimed at describing the responsibilities and obligations of platform providers under the European Medical Devices Regulation 2017/745 (MDR) and the European In-vitro Diagnostic Medical Device Regulation 2017/746 (IVDR) and the Digital Services Act (DSA). The guidance describes the responsibilities and obligations of platform providers that facilitate MDSW manufacturers in making their apps available in the Union market.

 

 

European Commission issues guidance on making safer apps available | Emergo by UL

European Commission issues guidance on making safer apps available