Notification of medical devices

Device Registration

The registration of devices, systems, and procedure packs according to Art. 108 MedDO will become mandatory in swissdamed as of July 1, 2026, with a transition period until December 31, 2026. Device registration

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.

Notification of medical devices

The notification obligation remains in place for the following devices:

• Custom-made devices according to Art. 19 MedDO
• 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

With the exception of custom-made devices according to Art. 19 MepV, only notifications of individual devices may be submitted from January 1^st, 2027, onwards.

As of 26 May 2021 the following medical devices have to be notified to Swissmedic:

Custom-made devices

Custom-made devices according to art. 19 MedDO of 1 July 2020. The notification obligation applies to persons (manufacturers, authorized representatives, importers or distributors) based in Switzerland or in Liechtenstein prior to making such devices available on the market. The following form must be submitted to Swissmedic:

Repackaged or relabelled medical devices

Repackaged or relabelled medical devices according to art. 53 or 54 MedDO of 1 July 2020. The notification obligation applies to persons (importers and distributors) based in Switzerland or in Liechtenstein prior to placing such devices on the market. The following form must be submitted to Swissmedic:

The product list template for the notification of a device group can be downloaded here:

Medical devices manufactured and used in health institutions (in-house MD)

Medical devices manufactured and used in health institutions according to art. 18 MedDO of 1 July 2020. The notification obligation applies to health institutions based in Switzerland or in Liechtenstein prior to putting such devices into service. The following form must be submitted to Swissmedic: