swissmedic recently announced that the Swiss medical device database, swissdamed, is now expected to be available in the second half of 2024. The database will comprise a module for actor registration (ACT) and a module for device registrations (UDI). The UDI module is scheduled to go live four months after the go live of the ACT module.
Since then, although Switzerland’s regulatory system is aligned with the EU, Switzerland is considered a third country from the perspective of the EU and vice versa.
The mutual recognition agreement (MRA) between the EU and Switzerland ended for medical devices May 26, 2021 or for in vitro diagnostic medical devices May 26, 2022 respectively. Since then, although Switzerland’s regulatory system is aligned with the EU, Switzerland is considered a third country from the perspective of the EU and vice versa. One of the consequences is that manufacturers from Switzerland need a European Authorised Representative. Manufacturers outside Switzerland in turn need to engage a Swiss Authorised Representative before placing their devices on the market there.
swissdamed will be a developed as another consequence – due to the expired MRA, Switzerland may not access data provided to EUDAMED.
In the meantime, promising news have been published by the European Commission in another recent press release. The release states negotiations between the Commission and Switzerland started on March 19 comprising several aims. One of the goals is to “relaunch […] negotiations towards agreements on electricity, food safety and health”. Timelines were not provided but it is hoped that the EU and Switzerland find a timely way back to an integrated market.
Should you require additional information or details, please don’t hesitate to get in touch.
Source: swissmedic, European Commission
