Swissdamed, which stands for “Swiss Database on Medical Devices”, is a new database implemented by Swissmedic to enforce the registration of economic operators and medical devices.
This database is necessary because the Mutual Recognition Agreement of conformity assessment (MRA) between the EU and Switzerland has not been updated to include the EU MDR. Therefore, the EU Database (EUDAMED) cannot be used in Switzerland as different legislations apply in the EU and Switzerland.
However, Swissdamed aims to the equivalence with EUDAMED and has similar modules.
Swissdamed will be implemented in three phases:
- Registration of economic operators
- Registration of medical devices
- Additional functions
Swissdamed: registration of economic operators
Article 55 of the Medical Devices Ordinance (MedDO) and Article 48 In Vitro Diagnostic Medical Devices Ordinance (IvDO) require that CH manufacturers, CH representatives and CH importers register to Swissmedic, while Swissdamed is still in development. Once the economic operators have registered, they will get the Swiss Single Registration Number, also known as CHRN.
The economic operators must register within three months that the device has been placed on the market for the first time. This timeframe wants to prevent delays in the compliance of medical devices. The CH distributor does not have to register.
While Swissdamed is still in development, economic operators have to register to Swissmedic by applying via e-mail. A clear guide on the application process can be find in Obelis Swiss GmbH website.
Those who have already registered with Swissmedic will not have to register again once Swissdamed is functional, as they already have the CHRN.
Once an economic operator has registered, it will not have to register again when placing new devices on the market.
It is essential to highlight that registration is not compulsory for now. However, an amendment to MedDo and IvDO to make registration compulsory is planned for 2023.
Do you wish to know more about the compliance requirements in Switzerland? Do not hesitate to contact Obelis Swiss GmbH!
Claudia Argenti
RA Department
09/12/2022
Interested in selling your medical devices in Switzerland? Obelis can act as your Swiss Authorized Representative and turn your Swiss journey into a success story! Contact us today.
References
MDlaw. September 2022. Swissdamed: Database for Medical Devices in Switzerland. Retrieved on 06/12/2022.
Obelis Swiss GmbH. March 2022. The Swiss Single Registration Number (CHRN). Retrieved on 06/12/2022.
Swissmedic. 2022. Obligations for authorised representatives, importers and distributors. Retrieved on 06/12/2022.
Swissmedic. 2022. Swissdamed – Swiss Database on Medical Devices. Retrieved on 06/12/2022.
Swissmedic. 2022. Swiss Single Registration Number (CHRN). Retrieved on 06/12/2022.
The information contained on obelis.ch is presented for general information purposes only, without obligation and it has been compiled with the utmost care to ensure it remains up to date. Nevertheless, Obelis Group cannot be held liable for the accuracy and completeness of the information published. Any reliance placed on such information is therefore strictly at the User’s risk.