Notification according to the MDR

Since the new Medical Devices Ordinance (MedDO, SR 812.213) came into effect on 26 November 2017, class I medical devices that satisfy the requirements of the MDR (Medical Devices Regulation (EU) 2017/745) can now be notified to Swissmedic according to Art. 6 MedDO. Swissmedic would point out that notifications relating to MDR medical devices are not currently uploaded to the EUDAMED database because the existing EUDAMED database is not set up for devices covered by the MDR, and the new EUDAMED is not yet operational. The requirements pertaining to EUDAMED stated in the new Regulation must be fulfilled by the manufacturer at a later date for the devices concerned. 

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

Manufacturers or authorised representatives of Class I medical devices (I, Is, Im, Ir) based in Switzerland are obliged to notify to Swissmedic. The legal basis for this requirement is Art. 6 of MedDO. 

The following form must be submitted to Swissmedic:

Systems & procedure packs

Systems and procedure packs are assembled from several conforming medical devices according to their intended purpose and are subject to the restrictions on use specified by the manufacturer.

Manufacturers or authorised representatives of systems and procedure packs based in Switzerland are obliged to report to Swissmedic. The legal basis for this requirement is Art. 6 MedDO.

The following form must be submitted to Swissmedic: 

Custom-made devices

Manufacturers or authorised representatives of custom-made devices must keep a list of all such devices as part of their quality management system. This list should be available for inspection by Swissmedic on request. The placing on the market of custom-made devices does not need to be reported to Swissmedic according to the MDR.

 

https://www.swissmedic.ch/content/swissmedic/en/home/medical-devices/new-eu-regulations--mdr--ivdr-/meldung-nach-mdr.html