Due to the status of the agreement on mutual recognition of conformity assessments (MRA) between Switzerland and the EU, Swissmedic has made adjustments to the registration process for economic operators (CHRN) and medical devices, including in vitro diagnostic medical devices with unique device identification (UDI). (Read the full legal text: Overview (swissmedic.ch)).
New Swissmedic Swissdamed Registration Requirements
Manufacturers will, from the point of implementation, not only bound by the device registration requirements defined in the Medical Devices Ordinance (MedDO; SR 812.213) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO; SR 812.219), but also by the obligations and modalities outlined in Articles 27, 29, and Annex VI of the EU-MDR, as well as Articles 24, 26, and Annex VI of the EU-IVDR.
These articles are expected to come into effect at a later date within MedDO and IvDO, contingent upon the availability of the required database (Art. 110 MedDO and Art. 91 IvDO).
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