Applications for a Certificate of Free Sale of medical devices compliant with Regulation 2017/745/EU on medical devices and Regulation 2017/746/EU on in vitro diagnostic medical devices must be submitted using the following form:
The following documentation must be submitted with the application:
- A list of the medical devices for which the Certificate of Free Sale is requested, in duplicate. One (1) copy of the list must be signed by the authorised representative and one (1) copy must be submitted on a blank sheet of paper, with no indication of the applicant’s company and no signature from the authorised representative. This copy will be enclosed with the Certificate of Free Sale. The list of medical devices must contain at least the trade name of the medical device, exactly as it was notified for entry in the Register of Medical Devices, as specified in the decision on entry in the register and as entered in the EUDAMED database. Additionally, the list may contain supplementary data relevant to the applicant (e.g. translations of device names into foreign languages);
- A statement confirming that the JAZMP will be notified immediately of any withdrawal of the medical device from the market.
Applicants may obtain a Certificate of Free Sale for medical devices entered in the Register of Medical Devices that have a valid registration decision and are recorded in the EUDAMED database.
NOTE: Applicants must submit applications for a Certificate of Free Sale for medical devices once decisions on the registration of medical devices have become final.
The validity of the certificate depends on the device’s risk class:
- Certificates of Free Sale for class I devices under the MDR or class A devices under the IVDR are valid for a period of one year from the date of issue;
- Certificates of Free Sale for high-risk devices issued by a notified body are valid for as long as the notified body’s certificate is valid.
Costs of procedure
Notified bodies, manufacturers, authorized representatives, importers, distributors, manufacturers of custom-made devices, reprocessors of medical devices, and healthcare institutions that manufacture in-house devices for their own use pay JAZMP annual fees as specified in the JAZMP Tariff for Medical Devices (Official Gazette of the Republic of Slovenia, No 6/26).
