Registration of medical device in accordance with the regulation (EU) 2017/745 (MDR)

Regulation (EU) 2017/745 on medical devices (hereinafter: MDR) became applicable on 26 May 2021.

Manufacturers established in the Republic of Slovenia and authorised representatives established in the Republic of Slovenia given the mandate by the manufacturer from a third country have the obligation to register medical devices.

Please note! Before registering the devices in accordance with the Regulation (EU) 2017/745, manufacturers or authorised representatives established in the Republic of Slovenia have to be listed in the JAZMP’s Register 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 has become applicable. 

The link to the above registration is available here.

The term “medical device” is defined in point 1 of paragraph one of Article 2 of the Regulation (EU) 2017/745, the term “accessory for a medical device” is defined in point 2 of paragraph one of Article 2 of the Regulation (EU) 2017/745, while “product” is defined in Annex XVI of the Regulation (EU) 2017/745.

FORM

The form is valid as a temporary form for the fulfilment of the obligation to register a medical device with the competent authority for medical devices, the JAZMP.

To register these devices complete the following form: Form: 689-02

The JAZMP does not register custom-made medical devices in accordance with the MDR, and does not keep the Register of medical devices. Manufacturers of custom-made devices, however, have to be registered.

COSTS OF PROCEDURE

The costs of procedure for entry in the Register of medical devices are specified in Article 8 of the Rules on fees in the field of medical devices (Uradni list RS, No.24/19).

Fees for the procedure relating to entry into the register of medical devices:

for initial registration:
  • 40 points per request (1 to 10 requests per application);
  • 35 points per request (11 to 20 requests per application);
  • 30 points per request (21 to 30 requests per application);
  • 25 points per request (over 31 requests per application to a maximum of 2,000 points);
for a change of data not affecting the entry in the register:
  • 20 points per request (1 to 10 requests per application);
  • 16 points per request (11 to 20 requests per application);
  • 12 points per request (21 to 30 requests per application);
  • 10 points per request (over 31 requests per application to a maximum of 800 points);
 for a change of data affecting the changes of the entry in the register:
  • 30 points per request (1 to 10 requests per application);
  • 25 points per request (11 to 20 requests per application);
  • 20 points per request (21 to 30 requests per application);
  • 15 points per request (over 31 requests per application to a maximum of 1,200 points).
NOTE: 

Each request means a model of the medical device for which a decision is issued.

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

The applicant pays the fee after receiving the notice of due payment or the notification on the payment method by the JAZMP.

The JAZMP sends a notification on the payment method to the email address indicated by the applicant in the application form. The applicant must pay the fee within 15 days to the sub-account of the JAZMP.

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