Regulation (EU) 2017/746 on in vitro diagnostic medical devices (hereinafter: IVDR) became applicable on 26 May 2022.
The obligation to register a medical device applies to manufacturers established in the Republic of Slovenia, as well as to authorised representatives established in the Republic of Slovenia who have been appointed by a third-country manufacturer.
The Medical Devices Act (Official Gazette of the Republic of Slovenia [Uradni list RS], No 40/25; hereinafter: ZMedPri-1), applicable as of 19 June 2025, defines device registration and the reporting of changes in Article 45.
Important: Before registering the devices that comply with Regulation 2017/746/EU, manufacturers or authorised representatives established in the Republic of Slovenia must first be registered with the JAZMP in the Register of economic entities established in the Republic of Slovenia that carry out activities relating to medical devices registered after Regulation (EU) 2017/746 on in vitro diagnostic medical devices became applicable.
The link to the relevant register is available here.
The term “in vitro diagnostic medical device” is defined in Article 2(2) of Regulation (EU) 2017/746, the term “accessory for an in vitro diagnostic medical device” is defined in Article 2(4) of Regulation (EU) 2017/746.
Form
In order to comply with the obligations set out in the Medical Devices Act (ZMedPri-1) and Regulation (EU) 2017/746, all medical devices must be registered with the competent authority for medical devices, the JAZMP, using Form 878-02.
