Registration of a device in accordance with Directive 93/42/EEC and Directive 90/385/EEC

In accordance with paragraph three of Article 120 of the MDR (transitional provisions), the devices in line with either of those directives and based on the issued CE Certificate can be placed on the market provided that from the date of application of the MDR it continues to comply with either of these directives and provided there are no significant changes in the design and intended purpose. The requirements of the MDR relating to post-market surveillance, market surveillance, vigilance, and of registration of economic operators shall apply in place of the corresponding requirements in these directives.

Exception: From 26 May 2021 onwards, risk Class I devices can only be placed on the market if they are in compliance with the MDR.

To register devices in accordance with one of these directives, complete the following forms:
COSTS OF PROCEDURE

The costs of procedure for entry in the Register of medical devices are specified in Article 8 of the Rules on fees in the field of medical devices (Uradni list RS, No.24/19).

Fees for the procedure relating to entry into the Register of medical devices:

for initial registration:
  • 40 points per request (1 to 10 requests per application);
  • 35 points per request (11 to 20 requests per application);
  • 30 points per request (21 to 30 requests per application);
  • 25 points per request (over 31 requests per application to a maximum of 2,000 points);
for a change of data not affecting the entry in the register:
  • 20 points per request (1 to 10 requests per application);
  • 16 points per request (11 to 20 requests per application);
  • 12 points per request (21 to 30 requests per application);
  • 10 points per request (over 31 requests per application to a maximum of 800 points);
for a change of data affecting the changes of the entry in the register:
  • 30 points per request (1 to 10 requests per application);
  • 25 points per request (11 to 20 requests per application);
  • 20 points per request (21 to 30 requests per application);
  • 15 points per request (over 31 requests per application to a maximum of 1,200 points).
NOTE: 

Each request means a model of the medical device for which a decision is issued.

The fees are specified in points. The value of one point is EUR 5 excluding value added tax (VAT). The amount of the fee is the point value multiplied by the number of points.

The applicant pays the fee after receiving the notice of due payment or the notification on the payment method by the JAZMP.

The JAZMP sends a notification on the payment method to the email address indicated by the applicant in the application form. The applicant must pay the fee within 15 days to the sub-account of the JAZMP.

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