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 defined in Articles 6. and 10. of the Rules relating to fees in the field of medical devices (Official Gazette of the Republic of Slovenia, No. 24/19)
- the annual fee for monitoring the implementation of conformity assessment procedures and the fulfilment of conditions for notified bodies is 4.000 points;
- the costs of the designation process for notified body on the field of medical devices on the day of the commission’s visit is 910 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.