Swissdamed is the Swiss equivalent of EUDAMED. For Manufacturers and Person Responsible for Regulatroy Compliance (PRRC) von Medizinprodukten ist die Registrierung in der swissdamed verpflichtend.
Use of the system is a prerequisite for compliance with legal requirements and can be decisive for market access.
The Swiss database is largely based on the EUDAMED, um die Übereinstimmung zwischen den schweizerischen und den EU-Regularien aufrechtzuerhalten. Diese Übereinstimmung wurde zuvor durch das MRA-Abkommen (Mutal-Recognition Agreement zwischen CH und EU) gewährleistet.
Both the Swiss and EU databases aim to improve the transparency and accessibility of information on medical devices and their manufacturers. The swissdamed as well as the structure and functionality of the corresponding EUDAMED modules. This should minimise the effort required by economic operators. This includes, among other things, the registration of operators and products as well as the management of safety corrective measures and trends. The harmonisation of regulations in Switzerland and the EU ensures compatibility and facilitates trade and cooperation between the two regions.
Use of swissdamed
Swissdamed is designed as a web application and offers both public and restricted access.
- The public area is accessible to everyone and contains information about registered economic operators and their products.
- The restricted area is available exclusively to economic operators and public authorities and contains further information that is not publicly visible.
Modules from swissdamed
Actor-Module
The actor-module is the first module offered by swissdamed and has been online since 6 August 2024. It enables economic operators based in Switzerland to register online. This module is of central importance for the management of data from manufacturers, importers and other relevant actors in the field of medical devices based in Switzerland. Companies not based in Switzerland must register for a CH-Representatives .
Device-Module
The device-module will be introduced in stages. The first phase will start in 2025 and allow voluntary registration of certain medical devices. The exact product specifications will remain open for the time being. From 1st July 2026 In accordance with the applicable regulations, all devices and systems on the Swiss market must be registered in swissdamed. Manufacturers or their authorised representatives have until 31. December 2026 , to register their products.
Deadlines
Important deadlines at a glance:
- 2025: The first components of the device module are available for voluntary registration of certain products.
- 1st July 2026: From this date onwards, all medical devices available in Switzerland must be registered in swissdamed. This also includes the immediate reporting of serious incidents, safety corrective measures and relevant statistically significant trends.
- 31. December 2026: Last date for registration of all devices by manufacturers or their representatives in Switzerland. After this date, only registered medical devices may be marketed in Switzerland.
Support from BEO BERLIN
Since 1st November 2021, BEO BERLIN has been offering the services of a CH-Representative. Contact us, if you wish to offer your medical devices on the Swiss market. As EU-Representative we also support Swiss companies that want to sell products in the EU.
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