Notification of IVD medical devices

IVD (In-Vitro Diagnostic) medical devices

First placers on the market who are Swiss-domiciled manufacturers or authorised representatives must notify Swissmedic when they place an IVD medical device on the market for the first time. The legal basis for this requirement is Art. 6 of the Medical Devices Ordinance. The originals of the standardised notification forms and any necessary additional documents must be submitted to Swissmedic.
The following Information sheet provides further details on this subject:
According to Annex II of Directive 98/79/EC, IVD medical devices and devices for self-testing must be notified individually. The following documents must be submitted to Swissmedic:
  • certification documents relating to the conformity assessment procedures (EC certificates), and
  • the instructions for use plus – in the case of devices "for self-testing" – the layout of the outer packaging.

"Other" IVDs can be notified individually or as product groups. The following document must be submitted to Swissmedic:

The following link provides an example of a declaration of conformity for an IVD medical device:

IVD medical devices manufactured in-house

IVD medical devices manufactured in-house are devices intended solely for use in the producing company or in a partner company that is integrated in the manufacturer's quality assurance system. IVD medical devices manufactured in-house must be notified if they are classed as medical devices according to Annex II of Directive 98/79/EC. The legal basis for this requirement is Art. 6, para.2 of the Medical Devices Ordinance.
The following Information sheet provides further details on this subject:
The following form and any necessary additional documents must be submitted to Swissmedic:
https://www.swissmedic.ch/content/swissmedic/en/home/medical-devices/market-access/notification-of-ivd-medical-devices.html