During the transitional phase, until the Ordinance on In Vitro Diagnostic Medical Devices (IvDO) is amended, Swissmedic is already going ahead with enforcement according to the EU amendment to avoid jeopardising the supply of in vitro diagnostic medical devices in Switzerland.
14.08.2024
In the EU, Regulation (EU) 2024/1860 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. In view of bottlenecks at the notified bodies, these amendments implemented a number of measures in the EU, including extension – under certain circumstances – of the validity of certificates issued under the old legislation until 2027/2028/2029 (depending on classification).
In its media release dated 14 August 2024, the Federal Council stated that these amendments must also be implemented in Switzerland to avoid any potential supply bottlenecks. In addition, the product registration obligation already set out in the MedDO and IvDO will enter into force in 2026. Amendment of the MedDO and IvDO is planned for autumn 2024.
For IVD devices whose certificates were issued in accordance with Directive 98/79 EC (“IVDD”) and which expired before 9 July 2024 or which expire after this date, Swissmedic will tolerate the conditions for extending the validity of the certificate in accordance with the EU-IVDR amendment as part of the enforcement of therapeutic products legislation.
Swissmedic will base its enforcement on the relevant EU interpretation documents.
Swissmedic is responsible for market surveillance in Switzerland. It may at any time order corrective measures in the context of administrative proceedings if necessary and in the interests of protecting health.