For medical devices in accordance with the regulation (EU) 2017/745 on medical devices (MDR) and regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)

The application for obtaining a Certificate of Free Sale for medical devices in accordance with the Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices should be submitted here:

When submitting the application, enclose the following documents:

  • list of medical devices that are subject to the Certificate of Free Sale, in duplicate. One (1) copy of the list must be signed by the authorised representative, and one (1) copy must be submitted on an unmarked sheet of paper without an indication of the applicant’s company and without the signature of the authorised representative to serve as an enclosure with the Certificate of Free Sale. The list of medical devices must contain at least the trade name of the medical device as notified for entry in the Register of Medical Devices and specified in the decision granting entry. In addition, the list may contain any data that are relevant for the applicant (e.g. translation into a foreign language)
  • a statement confirming that data on a potential withdrawal of a medical device from the market will be forwarded to the JAZMP immediately upon the withdrawal.

The applicant can obtain a Certificate of Free Sale for medical devices that are entered in the Register of Medical Devices and hold a valid decision.

The validity of the Certificate of Free Sale is subject to the device’s risk class:
  • Class I devices – Certificate of Free Sale is valid for 1 year from the date of issue,
  • for devices of higher risk classes, for which the certificate was issued by a notified body, the validity of the Certificate of Free Sale is subject to the validity date of the notified body’s certificate.

Please note: The applicant submits the application for the Certificate of Free Sale of medical devices after the decisions on registration of medical devices have become final.

COSTS OF PROCEDURE

The costs of the procedure for issuing a Certificate of Free Sale are specified in Article 9 of the Rules on fees in the field of medical devices (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 24/19).

The fee for issuing a certificate on free sale of medical devices amounts to 30 points.

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 JAZMP sub-account.

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