Switzerland’s Medical Device database: Swissdamed
Following the EU’s non-renewal of the Mutual Recognition Agreement of conformity assessment (MRA) between the EU and Switzerland, companies will now have to consider 2 sets of legislation for Switzerland and the EU.
Switzerland has released requirements for registration through the Medical Devices Ordinance (MedDO; SR 812.213) and the Ordinance for IVDs (IvDO; SR 812.219). Swissmedic, the Swiss Competent Authority, have announced plans for registration of all medical devices and in-vitro diagnostic medical devices (IVDs) on the Swissdamed database. This registration will become compulsory by 2023 as the database becomes available and the MedDO and the IvDO are amended.
Swissdamed, the Swiss Database on Medical Devices, similar to the EU’s EUDAMED database will register economic operators and devices placed on the Swiss market.
The Swissdamed database will be intended to reflect similar modules to the EU EUDAMED system to continue an aim of equivalence between the legislation of the two jurisdictions. Again, similar to EUDAMED, the whole Swissdamed system is yet to be operational, and a staged implementation is being carried out.
This is broken down into 3 stages:
1st Release – Economic Operator (EO) Registration
2nd Release – Medical Devices Registrations
3rd Release – Additional functionality within the EO and Device modules
Currently, economic operators are required to register with Swissmedic and will then receive a Swiss Registration Number (CHRN) and will not need to register again when the module is available.
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