17.08.2026
To the attention of users and economic operators carrying out activities with medical devices – on obtaining the approval for use for the import of medical devices
Given that the first four EUDAMED modules have become fully functional and mandatory, we hereby inform you that economic operators carrying out the activity of importing medical devices are obliged to register into the EUDAMED (the “Actor registration” module) and to obtain the SRN (Single Registration Number).
In order to obtain an operating permit or a modified permit for the activity of importing medical devices, economic operators must have an importer’s SRN, obtained after registration into the EUDAMED.