First registration in accordance with the Regulation (MDR) and (IVDR)

WITH AN ELECTRONIC APPLICATION ON THE SLOVENIAN BUSINESS POINT (SPOT)

Economic operators established in the Republic of Slovenia, who carry out business activities connected to medical devices, such as putting them on the market or into service, making them available on the market, or have been given a mandate by a manufacturer from a third country to represent it in the EU market, have to register at the JAZMP before they begin carrying out of activities in this field. 

The following operators shall be registered:
  • manufacturers
  • authorised representatives
  • importers
  • distributors
  • custom-made devices manufacturers

Economic operators submit an electronic application via the Slovenian Business Point (SPOT) portal.

LINK TO THE ELECTRONIC APPLICATION.

The application for registration can be submitted by any natural person with a digital certificate who is authorised to submit this application by the relevant economic operator.

The application is handled by the JAZMP that will issue a signed digital certificate of registration after the procedure has been concluded. The economic operator receives the certificate of registration at the e-mail address listed in the electronic application.

The procedure is free of charge. 

To view the instructions for completing the application on the SPOT portal, click here. 

Please note! If the economic operator is a manufacturer, manufacturer’s authorised representative, importer or manufacturer of systems and procedure packs, the economic operator should also be registered in the EUDAMED database (Actors Module). 

Link to EUDAMED (Actors Modul)

PAPER APPLICATION SENT TO THE JAZMP

In exceptional cases, i.e. the operator does not undertake business with a digital certificate, a paper application for registration can be submitted, using the paper form for the registration of economic operators established in the Republic of Slovenia.

To access the form, click here: Obr. 686-02_prvi vpis

Send the completed and stamped form signed by the person responsible for representing the company to the address JAZMP, Slovenčeva 22,1000 Ljubljana.

The application is handled by the JAZMP that will issue a signed digital certificate of registration after the procedure has been concluded. The economic operator receives the certificate of registration at the e-mail address listed in the electronic application.

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