For medical devices that obtained a CE marking in accordance with the Regulation (EU) 2017/745, or in the case of in vitro diagnostic medical devices in accordance with the Medical Devices Act (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 98/09), after a conformity assessment procedure, the principle of free movement applies.
The JAZMP can issue a manufacturer established in the Republic of Slovenia or an authorised representative established in the Republic of Slovenian a Certificate of Free Sale for their device that states that this manufacturer or authorised representative is established in territory of the Republic of Slovenia and that its CE-marked device can be placed on the EU market.
