agosto 22, 2025

Swissdamed UDI Devices module: medical device registration now available

On 18 August 2025, Swissmedic launched the new UDI Devices module in swissdamed, the national database for medical devices in Switzerland. This update makes it possible to register medical devices, in vitro diagnostic medical devices (IVDs), as well as systems and procedure packs.

Table of Contents

Deadlines and obligations

At this stage, registration is voluntary, but from 1 July 2026 it will become mandatory for all devices placed on the Swiss market.

A transitional period applies until 31 December 2026, with one exception: devices subject to reporting obligations for serious incidents, field safety corrective actions or trend reporting must be registered from 1 July 2026, without any transition.

Who must register devices

Swiss Manufacturers
Swiss Authorised representatives, for the devices under their mandate
Persons assembling systems and procedure packs

The registration requirement applies to all products sold in Switzerland.

Alignment with EUDAMED

To ensure consistency with the European framework, swissdamed has been designed in alignment with EUDAMED.

Most data prepared for EUDAMED can be reused, but the two databases are not connected. Device data must be uploaded actively into swissdamed, currently via XML file in the GET DEVICE or POST DEVICE format.

Legal basis

In Swiss law, the obligation to register devices is defined in Article 17(5) MedDO and Article 16(5) IvDO. Swissmedic is also aware of the further postponement of the device registration obligation in the EU and is monitoring the development of the corresponding timelines.

Regulatory implications for economic operators

With the launch of this module, swissdamed takes a significant step towards greater transparency and traceability in the Swiss medical device market. Companies should prepare early to ensure compliance with the new requirements and avoid potential risks.