As of 26 May 2021 the following medical devices have to be notified to Swissmedic:
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 prior to making such devices available on the market. The following form must be submitted to Swissmedic:
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 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 according to art. 18 MedDO of 1 July 2020. The notification obligation applies to health institutions based in Switzerland prior to putting such devices into service. The following form must be submitted to Swissmedic:
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 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 according to art. 108 MedDO of 1 July 2020. The notification obligation applies to persons (assemblers) based in Switzerland 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 according to art. 108 MedDO of 1 July 2020 or art. 103 MedDO of 1 July 2020, see:
FAQ - Notification of medical devices
In the information sheet you’ll find answers to frequently asked questions about notifications of medical devices.
