General

JAZMP maintains the Register of medical devices of manufacturers or authorised representatives of manufacturers of medical devices with a registered office in the Republic of Slovenia. 

A manufacturer of medical devices is a legal entity responsible for the designing, manufacturing, packaging, and labelling of a medical device before it is placed on the market under its own name, regardless of whether these operations are carried out by that entity or by a third party on their behalf. Authorised representative of the manufacturer of medical devices shall mean a legal entity established in the European Union, which is explicitly authorised in writing by a medical device manufacturer established in a third country to represent it, and who Competent Authorities may turn to relating to the obligations of Medical device manufacturer. 

In accordance with the provisions of the Medical Products Act (Official Gazette of the Republic of Slovenia, No. 98/09), only the following entities must notify medical devices for entering into the register:

  • Manufacturers of medical devices with a registered office in the Republic of Slovenia,
  • Authorised representatives of a manufacturer of medical devices with a registered office in the Republic of Slovenia,

 Notification is performed within 15 days from placing the medical device on the market. 

The procedure of entry into the register of medical devices

The applicant for entry into the register of medical devices submits an application.

For medical devices on forms:

  • Form MedPri-MP-obr07 (mandatory)
  • Annex MedPri-MP-obr07 (mandatory)
  • Annex 2 MedPri-MP-obr07 (complete only if necessary)
  • Annex 3 MedPri-MP-obr07 (complete only if necessary)
  • Annex 4 MedPri-MP-obr07 (complete only if necessary)

For in vitro diagnostic medical devices on forms:

  • Form MedPri-MP-obr08 (mandatory)
  • Annex MedPri-MP-obr08 (mandatory)


The following documentation must also be included in the application:

  • a copy of the EC certificate,
  • EC declaration of conformity,
  • Instructions for use.


Costs of the procedure

Costs of the procedure for entry into the register of medicinal devices are defined in Article 9 of the Rules on fees in the field of medicinal devices (Official Gazette of the Republic of Slovenia, No. 37/10). Fees for the procedure for entering medicinal devices into the register of medicinal devices are as follows:

  • 20 points for one generic name,
  • 30 points for a group of up to 10 generic names,
  • 50 points for a group of 11 to 50 generic names,
  • 100 points for a group of 51 to 100 generic names,
  • 150 points for a group above 100 generic names,

The fee for the procedure for amending an entry of medicinal devices in the register of medicinal devices is charged 20 points:

The fees are specified in points. Point value is EUR 5. The amount of the fee is the point value multiplied by the number of points. After reviewing the application, JAZMP sends a notice on the payment of a fee to the applicant with all information required for payment.