Theme Making available medical device software applications on the market
Target Audience Suppliers of medical device software application platforms
Products concerned MD and IVD software applications

In June 2025, the MDCG published a guide describing the roles and responsibilities of suppliers of medical device software application platforms.

As a reminder, software application suppliers can be considered as :

  • importers
  • distributors
  • intermediary service providers

Depending on their status, the requirements of the RDM/RDIV Regulations or the Digital Services Act will apply.