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.
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 January 1st, 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:
Class I medical devices
Class I medical devices according to art. 108 MedDO of 1 July 2020 in conjunction with art. 6 MedDO of 17 October 2001 (Status as of 1 August 2020). These are class I medical devices according to the Regulation (EU) 2017/745 (MDR) and class I medical devices according to the Directive 93/42/EEC, that fall under the classes Ir, IIa, IIb or III according to MDR. The notification obligation applies to manufacturers 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:
Systems and procedure packs
Systems and procedure packs according to art. 108 MedDO of 1 July 2020. The notification obligation applies to persons (assemblers) based in Switzerland or in Liechtenstein that assemble systems or procedure packs prior to placing such devices on the market. The following form must be submitted to Swissmedic:
Devitalised human tissue
Devitalised human tissue according to art. 108 MedDO of 1 July 2020 or art. 103 MedDO of 1 July 2020, see:
