The legal entity established in Slovenia that has been appointed by a decision of JAZMP and notified to the European Commission, is responsible for the conformity assesment of the medical device, its manufacturing and quality of operation with the requirements set out in European regulations and regulations of the Republic of Slovenia governing the area of medical devices.
The designation process
The designation process of body for carrying out conformity assessment procedures that has a registered office in the Republic of Slovenia is initiated by submission of an application to JAZMP, using form MedPri-MP-obr02 and enclosing evidence of fulfilment of the conditions in compliance with the Slovenian regulations governing this area.
Costs of the procedure
The costs of the designation process for notified body and annual fees for monitoring the implementation of conformity assessment procedures and the fulfilment of conditions for notified bodies are set out in Articles 4 and 7 of the Rules on fees in the field of medical devices (Official Gazette of the Republic of Slovenia, No 37/10).
After reviewing the application, JAZMP sends a notice on the payment of a fee to the applicant with all information required for payment.