Registers

Registers of economic operators established in the Republic of Slovenia that carry out activities relating to medical devices registered AFTER the application date of Regulation 2017/745/EU on medical devices and Regulation 2017/746/EU on in vitro diagnostic medical devices, in accordance with the Medical Devices Act (ZMedPri-1; Official Gazette of the Republic of Slovenia [Uradni list RS], No 40/25 with amendments)  

• Register of Medical Device Manufacturers 
• Register of Authorised Representatives
• Register of Manufacturers of Custom-Made Medical Devices
• Register of Manufacturers of Systems and Procedure Packs 
• Register of Distributors
• Register of Importers 
• Register of Health Institutions Manufacturing In-House Devices for Their Own Use

Register of Medical Devices compliant with Regulation 2017/745/EU on medical devices (MDR) and in vitro medical devices compliant with Regulation 2017/746/EU on in vitro diagnostic medical devices (IVDR) 

• Register of Medical Devices compliant with the MDR and IVDR whose manufacturers, or their representatives, are established in the Republic of Slovenia 

Register of Medical Devices compliant with Directive 90/385/EC on active implantable medical devices, Directive 93/42/EEC concerning medical devices, and Directive 98/79/EC on in vitro diagnostic medical devices 

• Register of Medical Devices Produced by Manufacturers or Their Representatives Established in The Republic Of Slovenia 

List of notified bodies established in the Republic of Slovenia 

• List of notified bodies established in the Republic of Slovenia