Applications for obtaining a Certificate of Free Sale for medical devices compliant with the following Directives:
- Council Directive 90/385/EEC on active implantable medical devices
- Council Directive 93/42/EEC concerning medical devices
- Directive 98/79/EC 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 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 and as specified in the decision on entry in the register. 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.
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 which may be placed on the market on the basis of the transitional provisions of Article 120 of the MDR or in vitro diagnostic medical devices classified under Directive 98/79/EC as risk class IVD other and which may be placed on the market on the basis of the transitional provisions of Article 110 of 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 is contingent on the validity date of the transitional period referred to in Article 120 of the MDR or Article 110 of the IVDR.
Procedure costs
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 of Free Sale for a medical device is 30 points.
The fees are specified in points. The value of one point is EUR 5 excluding value added tax (VAT). The fee amount is the point value multiplied by the number of points.
Applicants must pay the fee after receiving a payment notice or notification of the payment method from the JAZMP. The JAZMP will send a notification to the applicant regarding the payment method to the email address provided by the applicant in the application form. Applicants must pay the procedural fee within 15 days to the sub-account of the JAZMP.
