With the introduction of mandatory registration in swissdamed – the national database for medical devices and in vitro diagnostic medical devices – a standardised digital system replaces the existing notification procedures with effect from 1 July 2026.
Manufacturers and their authorised representatives must register devices, systems and procedure packs in the swissdamed UDI Devices module from 1 July 2026 – with a transitional period lasting until 31 December 2026. The online registration replaces the existing notification of certain devices.
What exactly is changing:
- Economic operators must register with Swissmedic before first placing a device on the market in Switzerland.
- The mandatory registration applies to all devices, systems and procedure packs for which sales units are placed on the market in Switzerland after 1 July. A transitional period applies until 31 December 2026 for these devices.
- Registration without a transitional period applies from 1 July 2026 to devices that have to be reported to Swissmedic due to serious incidents, field safety corrective actions (FSCAs) or a trend.
- Form-based notifications remain in place for repackaged or relabelled devices, DEVIT products according to Art 2a para. 2 TPA, devices manufactured and used in healthcare institutions ("in-house devices"), and custom-made devices.
- The existing notification for class I medical devices, systems and procedure packs, MD-DEVIT products and in vitro diagnostic medical devices in all risk classes is replaced by registration in swissdamed.
Registration fee
A fee of CHF 200 will be charged for the first UDI-DI, and a flat fee of CHF 20 will be charged for each additional UDI-DI with the status "On the market" (subject to a cost ceiling of CHF 10,000 per calendar year). The first invoices will be sent from January 2027. Devices that have already been registered by that date will be taken into account retrospectively.
Excerpt from the official page. The original is authoritative.