The English version of the website is currently being updated due to the update of content related to the adoption of the new Medical Devices Act (Official Gazette of the Republic of Slovenia, no. 40/25). Thank you for your understanding.

 

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 Regulation (EU) 2017/746, 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.