On August 6, 2024, the first module of the new Swissmedic database was released. It serves to register economic operators and medical devices, including in vitro diagnostics, which are marketed in Switzerland. This database, known as Swissdamed, is being introduced in stages and consists of two main modules: the Actor and Device modules.

The platform provides a central point of contact for all economic operators and patients who work with and are treated with medical devices in Switzerland. In this article, we will introduce the various modules of Swissdamed, important deadlines, and the use of the database.

Introduction of Swissdamed

Swissdamed is a database for storing manufacturer and medical device data. It was developed to improve the transparency and accessibility of information about these products and their manufacturers. It consists of the Actor and Device modules. Additionally, it allows users to register, manage, and look up economic operators and medical devices.

Modules of Swissdamed

Actor Module

The Actor module has been online since August 6, 2024, and allows economic operators to register. This module ensures that all actors are authenticated so that their data can be entered correctly and completely.

Device Module

The Device module will be introduced in several phases. Beginning in 2025, the first phase allows the voluntary registration of certain medical devices. The products in question are not specified. From July 1, 2026, all devices and systems available on the Swiss market must be registered in Swissdamed. Manufacturers or their authorized representatives have until December 31, 2026, to register their products. Swiss as well as foreign companies need to appoint an authorized representative for the Swiss database.

Important Deadlines

There are several important deadlines that Swissdamed users must observe:

• August 6, 2024: The Actor module has been available since this date. Companies and economic operators have the opportunity to register.
• November 13, 2024: All registered economic operators must validate their data. This is an important step to ensure the data integrity and reliability of the Actor module.
• 2025: Parts of the Device module are available for the voluntary registration of certain products. A specific date is not known.
• July 1, 2026: From this date, all medical devices available in Switzerland must be registered in Swissdamed. This also includes the immediate reporting of serious incidents, safety corrective actions, and related statistically significant trends.
• December 31, 2026: Deadline for the registration of all devices by manufacturers or their authorized representatives. From this point on, all medical devices available on the Swiss market must be registered.

Use of Swissdamed

According to its own statement, the use of Swissdamed is relatively simple and user-friendly. Here are the basic functions for using the database:

1. Registration of a company: Companies must register in Swissdamed by entering their company data and using a one-time confirmation code.
2. Management of actors: After registration, companies can add and manage their actors/users. This includes verifying and updating the data of each actor.
3. Registration of products: Medical devices marketed in Switzerland are registered, and their data is uploaded.
4. Search for medical devices: Upon completion of Swissdamed, patients will have the opportunity to independently obtain information about medical devices and their serious incidents.

Background and Legal Basis

The introduction of Swissdamed takes place against the background of the lack of an update to the Mutual Recognition Agreement (MRA) between Switzerland and the EU. Therefore, the registration of economic operators and medical devices is carried out directly by Swissmedic. Manufacturers are subject to the registration obligations according to the Medical Devices Ordinance (MedDO; SR 812.213) and the Ordinance on In Vitro Diagnostics (IvDO; SR 812.219).

Swissdamed and EUDAMED: A Close Connection

The Swiss database is closely modeled on EUDAMED to maintain the similarities between Swiss and EU regulations, previously given by the MRA. Both databases aim to improve the transparency and accessibility of information about medical devices and their manufacturers. Swissdamed also adopts the structure and functionality of the corresponding EUDAMED modules. The effort for economic operators is thus minimized. This includes the registration of actors and devices as well as the management of safety corrective actions and trends. This alignment ensures that the regulations in Switzerland and the EU are compatible, facilitating trade and cooperation between the two regions.

[Disclaimer]

This information is only one possible interpretation of the regulations. Also, they are in a constant state of change, so the information in this article may be incomplete or out of date. The above article is expressly no legal advice. Please refer to the official documents for information before making any business decisions. (Status of information: April 2025)