Mandatory Registration for Medical Devices in Switzerland Starting 1 July 2026

Key changes

Introduction of mandatory device registration in the swissdamed UDI Devices module; replacement of class I notifications; immediate registration required for vigilance-reportable incidents.

PV impact

MAHs and manufacturers must use swissdamed for device registration and vigilance-related reporting (incidents, FSCAs, trends) from 1 July 2026 without a transitional period.

Exact policy details

Mandatory registration start date

1 July 2026

Applies to: All medical devices, systems, and procedure packs placed on the market in Switzerland.

the introduction of mandatory registration in swissdamed · p. 1 · High · Source

Transitional period end date

31 December 2026

Applies to: Applies to devices, systems, and procedure packs for which sales units are placed on the market after 1 July 2026.

transitional period lasting until 31 December 2026 · p. 1 · High · Source

Registration fee for first device

CHF 200

Applies to: Fee for first UDI-DI registration per year.

A fee of CHF 200 will be charged for the first UDI-DI · p. 1 · High · Source

Registration fee for additional devices

CHF 20

Applies to: Fee for each additional UDI-DI with status 'On the market'.

a flat fee of CHF 20 will be charged for each additional UDI-DI · p. 1 · High · Source

Annual maximum fee

CHF 10,000

Applies to: Cost ceiling per manufacturer per calendar year.

subject to a cost ceiling of CHF 10,000 per calendar year · p. 1 · High · Source

First invoicing date

January 2027

Applies to: For devices registered by 31 December 2026.

The first invoices will be sent from January 2027 · p. 1 · High · Source

Workflow rule impacts

Extracted documents

• swissdamed: As of 1 July 2026, mandatory registration applies to medical devices and in vitro diagnostic medical deviceshtmlhtml · high · 1 page
• Medical deviceshtmlhtml · medium · 1 page
• Contacts / Linkshtmlhtml · high · 1 page
• Registration feehtmlhtml · high · 1 page