Swissdamed (Swiss Database on Medical Devices)

Swissdamed is the medical device database operated by Swissmedic. It supports actor identification and device traceability for the Swiss market, alongside the applicable MedDO and IvDO obligations. A database entry does not itself establish product conformity.

Who registers as an actor, and what is a CHRN?

The Swiss Single Registration Number (CHRN) identifies an eligible economic operator and role. Applicable manufacturers, authorized representatives, importers and system/procedure-pack assemblers in the Switzerland/Liechtenstein common market register with Swissmedic. The CHRN instructions require registration before first placing a device on the market.

Manufacturers outside that common market generally work through a CH-REP. The representative registers its own actor role and records the manufacturer mandate; it does not obtain a manufacturer CHRN on the foreign manufacturer's behalf. Eligible Liechtenstein manufacturers do not need a separate Swiss representative simply because they are outside Switzerland.

Who uploads devices?

Applicable local manufacturers, assemblers and authorized representatives register the relevant devices or mandated portfolios in the UDI Devices module. Foreign-manufacturer users can be given device-upload permissions under a mandate; access is not categorically prohibited. Importers link their own CHRN-IM to registered devices rather than creating those device records.

Determine the applicable scope for the actual product. Certain categories retain separate notification requirements, so “every product goes into the same UDI workflow” is not a sufficient registration plan.

When did mandatory device registration begin?

The general device-registration obligation began on 1 July 2026, with completion by 31 December 2026 under the transition. Relevant portfolios include devices with further sales units placed after the obligation began. Certain serious-incident, FSCA and trend cases require immediate registration once the necessary information is known.

Special cases apply, including Master UDI-DI dates for optical devices and the treatment of associated legacy devices. The database FAQ explains scope and exceptions. The device-registration page also describes the current special case for high-risk devices whose EUDAMED export depends on notified-body certificate confirmation. Check both before assigning deadlines across a portfolio.

Actor registration predates the platform: Swissmedic's economic-operator registration system dates to 26 November 2021, and the swissdamed Actors module became available in August 2024.

Is swissdamed connected to EUDAMED?

There is no automatic data synchronization with EUDAMED. Operators must actively submit Swiss records. Compatible EUDAMED GET DEVICE or POST DEVICE XML files can be reused through upload. Swissmedic also offers manual entry and a machine-to-machine REST API using JSON. Validate the uploaded data and market status instead of assuming that an EU record has completed the Swiss obligation.

How are device-registration fees calculated?

Swissmedic's fee rules set CHF 200 for the first device and CHF 20 for each additional device, capped at CHF 10,000 per annual calculation for each manufacturer or system/procedure-pack assembler. Each device is billed once in its initial registration year; this is not a recurring annual charge for every unchanged device. Updates to existing data are free.

The initial assessment is based on relevant UDI-DIs marked “On the market” at 31 December 2026; records marked “No longer placed on the market” at that date are excluded. Subsequent annual calculations cover newly registered products. Fees are assessed per manufacturer or assembler, with foreign-manufacturer invoicing handled through the CH-REP. Representation and consulting charges are separate.