REGULATORY AUTHORITY: Devices are regulated by the EU list of Competent Authorities. In Slovenia, devices are regulated by the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP).
CLASSIFICATION SYSTEM: Medical devices are classified according to risk into Classes I, IIa, IIb and III.
TIMEFRAME: The registration process takes about 4-6 weeks after submission for Class I devices. For the other classes, it depends on the contract with the notified body and the type of device.
LICENSE VALIDITY: Licenses issued in the EU are valid for five years.
AUTHORIZED REPRESENTATIVE: An authorized representative is required anywhere in the European Union.
ADDITIONAL INFORMATION: On 5 April 2017, 2 new Regulations on medical devices were adopted, and they entered into force on 25 May 2017. These replace the existing Directives. The new rules will only apply after a transitional period. Namely, 3 years after entry into force for the Regulation on medical devices (spring 2020) and 5 years after entry into force (spring 2022) for the Regulation on in vitro diagnostic medical devices.
In accordance with the provisions of the Medical Products Act of the Republic of Slovenia, only Manufacturers of medical devices or Authorized representatives with a registered office in the Republic of Slovenia, must notify medical devices for entering into the register.
