Swissmedic: Amendment of the Ordinance on In Vitro Diagnostic Medical Devices (IVDs)
The amended Ordinance on In Vitro Diagnostic Medical Devices (IvDO) enters into force on 1 January 2025. Switzerland is implementing extended transitional periods in line with the EU Regulation 2024/1860.
The Regulation 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.
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.
Source:
Swissmedic: General communications
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