Registration of in vitro diagnostic medical device in accordance with the regulation (EU) 2017/746 (IVDR)

Regulation (EU) 2017/746 on in vitro diagnostic medical devices (hereinafter: IVDR) will become applicable on 26 May 2022.

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 in vitro diagnostic medical devices in accordance with the Regulation (EU) 2017/746, 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 in vitro diagnostic medical devices, registered after the Regulation (EU) 2017/746 on in vitro diagnostic medical devices has become applicable. 

The link to the above registration is available here.

The term ‚Äúin vitro diagnostic medical device‚ÄĚ is defined in point 2 of Article 2 of the Regulation (EU) 2017/746, the term ‚Äúaccessory for in vitro diagnostic medical device‚ÄĚ is defined in point 4 of Article 2 of the Regulation (EU) 2017/746.¬†

FORM

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

To register these devices complete the following form: Form: 693-01

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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