Last updated: 6 August 2024
This post is an attempt to provide basic information about Swissdamed and progress with its availability.
To see the updates, click on ‘+’ sign below.
About Swissdamed
Swissdamed is Swissmedic’s new database for registering economic operators and medical devices as well as in-vitro diagnostics on the Swiss market.
Swissdamed:
- is a Swissmedic IT system that will make it possible to apply the Swiss regulations on medical devices and in vitro diagnostic medical devices.
- is structured around two interconnected modules (“Actors” module and “Devices” module), which only registered users can access. The individual modules will be made available in stages. The first of two modules (the ‘Actors’ module) went online on 6 August 2024.
- aims to provide an overview of the medical devices, including in vitro diagnostic medical devices, available on the Swiss market and the economic operators responsible for them. In future, the database will gather, process and publish information about medical devices and the companies concerned (e.g. manufacturers).
- will increase transparency by improving the access to information for the public and healthcare professionals.
Why is it necessary to have Swissdamed?
Since the agreement on mutual recognition of conformity assessments (MRA) between Switzerland and the EU has not been updated (it ceased to apply on 26 May 2021), registration of economic operators (CHRN) and of medical devices and in vitro diagnostic medical devices (unique device identification, UDI) is carried out directly by Swissmedic.
Swissdamed is necessary to apply Swiss regulations on medical devices and in vitro diagnostic medical devices.
About the modules of Swissdamed
Swissdamed consists of two modules (“Actors” module and “Devices” module) and a public website for the registration of economic operators with immediate effect and, over the course of 2025, certain medical devices (voluntary registration).
In order to preserve equivalence between the Swiss and EU regulations and minimise the effort for economic operators, swissdamed resembles the corresponding modules of the European database EUDAMED.
Manufacturers Device registration requirements in Switzerland
Manufacturers are subject not only to the device registration requirements stated in the Medical Devices Ordinance (MedDO; SR 812.213) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO; SR 812.219) but also to the obligations and modalities associated with Articles 27, 29 and Annex VI of the EU-MDR and Articles 24, 26 and Annex VI of the EU-IVDR.
The above-mentioned articles will enter into effect at a later date in MedDO and IvDO, as the database required for this purpose must first be made available (Art. 110 MedDO and Art. 91 IvDO).
What is the progress thus far with the availability of Swissdamed modules?
| Date | Event |
|---|---|
| 26 Jul 2024 | Applications for registration and for changing the CHRN, as well as notifications for mandates, will continue to be accepted as PDF forms until 26 July 2024 (submission date). After that date, these forms will no longer be considered. |
| 6 Aug 2024 | The ‘Actors’ module of swissdamed is available from 6 August 2024 ror the registration of economic operators with immediate effect. After this date, economic operators will be registered exclusively through application via www.swissdamed.ch. The e-mail inbox CHRN@swissmedic.ch will be replaced by an online contact form. |
| What happens from August 2024 for operators who are already registered? | The data for the almost 3,700 economic operators who have already registered with Swissmedic, and therefore possess a CHRN, will be migrated. At the start of August, the registered operators will be informed by letter, via the contact person stated to us during registration, about what happens next. They will not need to register again; they will simply have to check their data once these have been imported into swissdamed. Economic operators who had already registered with Swissmedic before swissdamed became available have been informed about the next steps via the contact person provided. |
| 2025 ‘Devices’ module | The second module “Devices” will go live in several phases: after the first release in 2025, it will be possible to register certain medical devices voluntarily, specifically “Regulation Devices” (MDR and IVDR), which will be uploaded using XML files in the EUDAMED format. Subsequent releases will complete the Devices module. |
When will devices registration become mandatory on Swissdamed?
Device registration will become mandatory only when swissdamed has been sufficiently developed and relevant amendments have been made to the MedDO/IvDO.
Where can you access Swissdamed?
Swissdamed can be accessed via this link.
Source:
- Swissmedic
- Go-live for the swissdamed Actors module (Swissmedic)