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 submits an application for entry a medical device into the register of medical devices only after the completion procedure for the entry into the register of manufacturers of medical devices with a registered office in the Republic of Slovenia.

Instructions for submition of application are on the forms MedPri-MP-obr07 and MedPri-MP-obr08.

For medical devices on forms:

  •          Form MedPri-MP-obr07 (mandatory)
  •          Annex MedPri-MP-obr07 A, B or C (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 A, B or C (mandatory)

Costs of the procedure

Costs of the procedure for entry into the Register of medical devices are defined in Article 8 of the Rules relating to fees in the field of medical devices (Official Gazette of the Republic of Slovenia, No. Opens external link in new window24/19).

Fees for the procedure for entering medical devices into the register of medical devices:

 

-          First entry in the register of medical devices:                                                                              

  •          40 points per application (for 1 to 10 applications in the role)
  •          35 points per application (for 11 to 20 applications in the role)
  •          30 points per application (for 21 to 30 applications in the role)
  •          25 points per application (over 31 applications in the role or the most 2.000 points)

-          Entry without a change in the register:                                                                                              

  •          20 points per application (for 1 to 10 applications in the role)
  •          16 points per application (for 11 to 20 applications in the role)
  •          12 points per application (for 21 to 30 applications in the role)
  •          10 points per application (over 31 applications in the role or the most 800 points)

Entry with a change in the register:                                                                                          

  •          30 points per application (for 1 to 10 applications in the role)
  •          25 points per application (for 11 to 20 applications in the role)
  •          20 points per application (for 21 to 30 applications in the role)
  •          15 points per application over 31 applications in the role or the most 1200 points)

 

NOTE: Each application means a model of a medical device for which the decision is issued.

 

The fees are specified in points. Value of one point is 5 EUR excluding tax. The amount of the fee is the point value multiplied by the number of points.

The applicant pays the fee upon the receipt of the JAZMP’s call for payment or notification from JAZMP regarding payment of the fee.

JAZMP sends a notification regarding payment of the fee to the e-mail address of the applicant. The applicant pays the procedure fee within 15 days to the JAZMP account.