GENERAL
Medical devices that have upon conformity assessment procedure obtained the CE marking in accordance with the regulations of the European Union and regulations of the Republic of Slovenia (Medical Devices Act, Official Gazette of the Republic of Slovenia, No. 98/09), which manage this field, have no limitations for placing on the market or putting into service in the territory of the European Union, which means that free movement applies.
At the request of the applicant, JAZMP may issue a certificate of free sale, which certifies that the medical device in question or a group of medical devices on the market is in accordance with the regulations of the European Union.
Certificate of free sale of a medical device may only be obtained by manufacturers of medical devices with a registered office in the Republic of Slovenia based on a decision issued on the entry in the register of medical devices.
PROCEDURE OF ISSUING A CERTIFICATE OF FREE SALE
The applicant submits the application for obtaining a Certificate of free sale on the MedPri-MP-obr09 form and includes the following documentation: list of medical devices he wishes to obtain the Certificate of free sale for, in two copies. One (1) copy of the list should be signed by the authorised person of the applicant and one (1) copy on a clean blank sheet, which is without any markings of the company of the applicant and without a signature of the authorised person of the applicant, which will be an annex to the Certificate of free sale.
- List of medical devices must include at least the trade name of the medical device, in the form as it was notified for entry in the register of medical devices and as listed on the issued decision on the entry. The list may also include information that is relevant to the applicant (i.e. translations into a foreign language, catalogue number, and similar),
- Statement that information on potential withdrawal of the medical device from the market will be sent to JAZMP immediately after withdrawal.
The applicant may obtain the Certificate of free sale for those medical devices that are entered into the register of medical devices and hold a valid decision. Issuing a Certificate of free sale is bound to the decision on entry to the register of medical devices, which means that one Certificate of free sale cannot list medical devices that are bound to different applicable decisions on entry.
NOTE: Applicant submits the application for issuing a certificate of free sale only after the decision on the entry of a medical device into the register of medical device is final.
COSTS OF THE PROCEDURE
Costs of the procedure for issuing the Certificate of free sale are defined in Article 9 of the Rules relating to fees in the field of medical devices (Official Gazette of the Republic of Slovenia, No. 24/19).
The fee for issuing a single certificate of free sale is 30 points.
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.