1 July 2026

With the introduction of mandatory registration in swissdamed – the Swiss national database for medical devices and in vitro diagnostic medical devices – a standardised digital system replaced 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, and economic operators must register with Swissmedic before placing a device on the Swiss market for the first time.

The obligation applies to all devices, systems, and procedure packs placed on the Swiss market after 1 July 2026, subject to a transitional period until 31 December 2026; for devices reportable to Swissmedic on account of serious incidents, field safety corrective actions (FSCAs), or a trend, registration applies from 1 July 2026 with no transitional period. The new registration replaces the previous notification requirement for class I medical devices, systems and procedure packs, MD-DEVIT products, and in vitro diagnostic medical devices in all risk classes, whereas form-based notifications remain in place for repackaged or relabelled devices, DEVIT products under art. 2a para. 2 of the Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (TPA), in-house devices, and custom-made devices. A fee of CHF 200 is charged for the first UDI-DI and CHF 20 for each additional UDI-DI with the status "On the market", subject to a ceiling of CHF 10,000 per calendar year, with the first invoices to be issued from January 2027.

For more information, see here.