Registers

Registers of economic operators established in the Republic of Slovenia that carry out activities in the field of medical devices registered AFTER the Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices have has become applicable

• Register of distributors
• Register of importers
• Register of manufacturers
• Register of authorised representatives
• Register of manufacturers of custom-made devices

Registers of economic operators established in the Republic of Slovenia that carry out activities in the field of medical devices BEFORE the Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices became applicable

• Register of medical device manufacturers established in the Republic of Slovenia
• Register of business entities carrying out wholesale trade in medical devices
• Register of specialised stores carrying out retail trade in medical devices

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

• Register of medical devices in accordance with the MDR whose manufacturers or manufacturer’s representatives have their registered office in the Republic of Slovenia

Register of medical devices in accordance with the Directive 90/385/EC on active implantable medical devices, Directive 93/42/EEC on medical devices, Directive 98/79/EC on in vitro diagnostic medical devices

• Register of medical devices whose manufacturers or manufacturer’s representatives have their registered office in the Republic of Slovenia

 The list of notified bodies established in the Republic of Slovenia.

• The list of notified bodies established in the Republic of Slovenia.