Medical Devices (MD) registration
When will the registration of Medical devices and procedure packs in Swissdamed become mandatory and replace the notification obligation and is there a transition period?
The registration of devices, systems, and procedure packs according to Art. 108 MedDO will become mandatory in swissdamed as of 1 July 2026, with a transition period until 31 December 2026.
To which MD devices does the registration obligation apply?
The registration obligation applies to devices under the existing legislation (MedDO) and to devices under the old legislation according to Art. 101 MedDO (“legacy devices”), which continue to be placed on the market at the time the registration obligation enters into force.
The registration obligation replaces the notification obligation by 1st July 2026.
For which Medical Devices will the notification obligation remain in place?
The notification obligation remains in place for the following devices:
- Repackaged or relabelled medical devices according to Art. 53 or 54 MedDO
- Medical devices manufactured and used in health institutions according to Art. 18 MedDO
- Custom-made devices according to Art. 19 MedDO
With the exception of custom-made devices according to Art. 19 MepV, only notifications of individual devices may be submitted from 1 January 2027, onwards.
Source: Swissmedic
In-Vitro diagnostic (IVD) Devices registration
When will the registration of In-Vitro diagnostic (IVD) Devices in Swissdamed become mandatory and replace the notification obligation and is there a transition period?
The registration of devices according to Art. 90 IvDO will become mandatory in swissdamed as of 1 July 2026, with a transition period until 31 December 2026. Device registration
To which IVD devices does the registration obligation apply?
The registration obligation applies to devices under the existing legislation (IvDO) and to devices under the old legislation according to Art. 82 IvDO (“legacy devices”), which continue to be placed on the market at the time the registration obligation enters into force.
The registration obligation replaces the notification obligation by 1st July 2026.
For which IVD Devices will the notification obligation remain in place?
The notification obligation remains in place for the following IVD devices:
- Repackaged or relabelled IVDs according to art. 46 para. 4 and art. 47 para. 4 IvDO
- IVDs manufactured and used in healthcare institutions according to art. 10 IvDO
From 1 January 2027, only notifications of individual devices may be submitted.
Source: Swissmedic