Swiss Database on Medical Devices – swissdamed!

qtq80 1EUUwv e1711424630380 2024
Swissmedic released a comprehensive guidance document for the implementation of the Swiss Database on Medical Devices – swissdamed.

Feel fully prepared by checking it out on the Swissmedic website or downloading it here!

This decision is in line with the regulatory frameworks outlined in the Medical Devices Ordinance (MedDO; SR 812.213) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO; SR 812.219), as well as the obligations and modalities associated with Articles 27, 29 and Annex VI of the EU-MDR and Articles 24, 26 and Annex VI of the EU-IVDR.

Swissdamed is expected to be available for registrations at the beginning of 2024. The device registrations will become compulsory once the applicable Regulation has been amended.

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