With the entry into force today of the amended Ordinance on In Vitro Diagnostic Medical Devices (IvDO), Switzerland is implementing extended transitional periods in line with the EU Regulation. This restores regulatory equivalence with the EU.
Amendment of the Ordinance on In Vitro Diagnostic Medical Devices (IVDs) and the Medical Devices Ordinance
The amended Ordinance on In Vitro Diagnostic Medical Devices (IvDO) enters into force on 1 January 2025
01.01.2025
Regulation (EU) 2024/1860 [LINK] amending the EU-IVDR with regard to the transitional provisions for certain in vitro diagnostic medical devices and amending the EU-MDR and EU-IVDR as regards a gradual roll-out of EUDAMED was adopted on 13 June 2024. This has, among other things, extended the validity of certificates issued under the old legislation in the EU to 2027, 2028 or 2029 – depending on risk class – to address bottlenecks at the notified bodies. This and the planned permanent simplification of mandatory labelling for devices dispensed by professionals (Article 87 IvDO) should ensure the supply of IVDs in Switzerland.
Healthcare institutions also have more time to prove that their in-house devices/laboratory-developed tests (LDTs) cannot be replaced by equivalent CE-marked devices on the market. This obligation to provide proof will only enter into effect on 31 December 2030, rather than on 26 May 2028 as originally stipulated.
The new notification obligation according to Article 10a EU-MDR and EU-IVDR, under which the manufacturer must provide notification of interruption or discontinuation of the supply of certain medical devices is not part of this revision of the Swiss ordinances.
The amendments mentioned were approved with the Federal Council decision of
20 November 2024 [LINK] and enter into force on 1 January 2025.
In addition, the device registration obligation already set out in the Medical Devices Ordinance (MedDO) and IvDO will enter into force from 1 July 2026, six months after the expected registration obligation in EUDAMED.