On 14 August 2024, the Swiss Federal Department of Home Affairs (FDHA) announced Switzerland’s alignment with the EU extension for legacy IVDs, labelling simplification for certain IVDs, and Swissdamed registration obligations. The FDHA proposed amendment of legal texts to the Federal Council by the end of the year.
Since May 2022, there is no mutual recognition agreement between the EU and Switzerland and therefore, IVDs must comply with the Swiss legislation when entering Switzerland. Nonetheless, the Swiss government has adopted several measures to avoid some financial and administrative burdens for medical devices’ companies.
Extensions for legacy IVDs
With the latest EU IVDR updates, new transition periods replace the initial transitional timelines for legacy devices. Typically, legacy devices which are transitioning towards the Regulation and the respective certification can be subject to this extension.
The new transitional period for IVDR legacy devices are:
- 31 December 2027 for Class D and devices covered by an IVDD CE Certificate
- 31 December 2028 for Class C
- 31 December 2029 for Class B and A sterile
Swissdamed registration obligation
According to the medical devices and IVD legislation, all devices must be registered in a centralised databank, the «Swiss Database on Medical Devices» or Swissdamed. This will allow a higher transparency on product information and their availability in the supply chain. Currently, some Swissdamed modules will be available in 2025 for the registration of certain devices on a voluntary basis. The registration obligation will start in 2026. The actor module is already available for registration as of August 2024.
Do you have questions on how to place medical devices and IVDs on the Swiss market? Contact us here!
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