The amended regulation on in-vitro diagnostic medical devices (IvDV) came into force on 1 January 2025.
With the entry into force of the amended Ordinance on In Vitro Diagnostics (IVDV) today, Switzerland is implementing the extended transition periods in accordance with the EU regulation. This restores regulatory equivalence with the EU.
On June 13, 2024, the “Regulation (EU) 2024/1860 adapting the EU IVDR as regards the transitional provisions for certain in vitro diagnostic medical devices and adapting the EU MDR and EU IVDR as regards the gradual introduction of EUDAMED” was published.
- In the EU, this extended, among other things, the validity periods for certificates under the old law – depending on the risk class – until 2027, 2028 or 2029 in order to address bottlenecks at the notified bodies.
- This and the planned permanent simplification of the labeling requirement for products supplied to professionals (Article 87 IvDV) are intended to ensure the supply of IVDs in Switzerland.
- Healthcare institutions will also be given more time to prove that their “in-house products” / “laboratory developed tests” (LDT) cannot be replaced by comparable CE-marked market products. This proof requirement will not come into force until December 31, 2030, instead of May 26, 2028 as originally required.
- The aforementioned adjustments were adopted by the Federal Council decision of 20 November 2024 and came into force on 1 January 2025.
Note that the new reporting obligation under Article 10a EU-MDR and EU-IVDR, according to which manufacturers must report the interruption or termination of the supply of certain medical devices, is not part of this Swiss regulation revision.
In addition, the product registration requirement already provided for in the Medical Devices Regulation (MepV) and the IvDV will come into force on 1 July 2026, six months after the expected registration requirement in EUDAMED.
Source: Swissmedic