Regulation (EU) 2017/745 on medical devices (hereinafter: MDR) became applicable on 26 May 2021.
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 devices that comply with Regulation 2017/745/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 the application date of Regulation (EU) 2017/745 on medical devices.
The link to the above registration is available here.
The term “medical device” is defined in Article 2(1) of Regulation 2017/745/EU, the term “accessory for a medical device” is defined in Article 2(1), point 2, of Regulation 2017/745/EU, while “product” is defined in Annex XVI to Regulation 2017/745/EU.
Form
In order to comply with the obligations set out in the Medical Devices Act (ZMedPri-1) and Regulation 2017/745/EU, all medical devices must be registered with the competent authority for medical devices, the JAZMP, using Form 877-02.
The JAZMP does not register custom-made medical devices in accordance with the MDR, and does not keep the Register of medical devices. However, the registration of manufacturers of custom-made devices remains mandatory.
