Medical devices that have undergone conformity assessment and received a CE marking in accordance with Regulation 2017/745/EU on medical devices (hereinafter: MDR), or in the case of in vitro diagnostic medical devices in accordance with Regulation 2017/746/EU on in vitro diagnostic medical devices (hereinafter: IVDR) are subject to the principle of free movement.
In accordance with Article 9 of the Medical Devices Act (ZMedPri-1), the JAZMP is required to issue a Certificate of Free Sale (CFS) within 30 days of receiving a complete application, either to the manufacturer, or the manufacturer’s authorised representative, both established in the Republic of Slovenia (RS) (pursuant to Article 60 of the MDR or Article 55 of the IVDR) for the relevant medical device. The certificate confirms that the manufacturer or the authorised representative, as applicable, has its registered place of business on the territory of Slovenia and that the device in question bearing the CE-marking may be marketed in the European Union.
The content of the application required to obtain the Certificate of Free Sale under Article 60 of the MDR or Article 55 of the IVDR is determined by the JAZMP, in agreement with the minister responsible for health, through a general act that is currently under preparation.
