| 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.