Notification for classes I, Im & Is and systems

Classical medical devices in class I (I, Is, Im)

First placers on the market who are Swiss-domiciled manufacturers or authorised representatives must notify Swissmedic when they place class I (I, Is, Im) medical devices on the market for the first time. The legal basis for this requirement is Art. 6 of the Medical Devices Ordinance.

The following form must be submitted to Swissmedic:
The following link provides an example of a declaration of conformity for a class I medical device:

Systems & treatment units

Systems and treatment units are assembled from several conforming classical medical devices according to their intended use and are subject to the restrictions on use specified by the manufacturer.
First placers on the market who are Swiss-domiciled manufacturers or authorised representatives must notify Swissmedic when they place a system/treatment unit on the market for the first time. The legal basis for this requirement is Art. 6 of the Medical Devices Ordinance.

The following form must be submitted to Swissmedic:
The following Information sheet provides further details on this subject:
https://www.swissmedic.ch/content/swissmedic/en/home/medical-devices/market-access/notification-for-classes-i--im---is-and-systems.html