Performance evaluation studies

Medical devices include in vitro diagnostic medical devices, for which the Medical Devices Act (Official Gazette of the Republic of Slovenia [Uradni list RS], No.98/09) and the rules related thereto are fully applicable in the Republic of Slovenia.

The European regulation governing in vitro diagnostic medical devices, i.e. Regulation (EU) 2017/746 on in vitro diagnostic medical devices (hereinafter: Regulation (EU) 2017/746 (IVDR)), will apply from 26 May 2022.

The safety and performance of in vitro diagnostic medical devices are established on the basis of studies evaluating their performance.

Performance evaluation studies are carried out for in vitro diagnostic medical devices that do not bear the CE marking. These studies are also carried out for in vitro diagnostic medical devices that have already obtained the CE marking, where the aim of the study is the use of the device for purposes other than those that were the subject of the conformity assessment procedure.

The manufacturer of the in vitro diagnostic medical device or its representative (hereinafter: applicant) must notify the performance evaluation study of a device by submitting an application to the JAZMP.

The JAZMP will issue a decision on the notification within 60 days of receiving a complete application. The performance evaluation study of the in vitro diagnostic medical device may start once the positive decision has become final.

NOTIFICATION PROCEDURE

To notify a performance evaluation study for an in vitro diagnostic medical device, the applicant must submit an application in paper or electronic format, whereby the latter must be signed by qualified electronic signature, using the form MedPri-MP-obr05 Application for notification of a performance evaluation study for an in vitro diagnostic medical device and enclosing the documents specified therein. In the case of an incomplete application, the JAZMP must, within 30 working days of its receipt, request the applicant to supplement their application and set a deadline by which it must be supplemented.

Article 20 of the Rules on medical devices (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 37/10, 66/12) sets out the procedure for the notification of a performance evaluation study for an in vitro diagnostic medical device.

The applicant may decide at any time to modify the performance evaluation study for an in vitro diagnostic medical device. To modify a performance evaluation study for an in vitro diagnostic medical device, the applicant must submit an application in paper or electronic format, whereby the latter must be signed by qualified electronic signature, using the form MedPri-MP-obr06 Application for notification of a modification of a performance evaluation study for an in vitro diagnostic medical device. The notified modification may be implemented if the JAZMP does not issue a negative decision within 30 days of receiving a complete application for the modification.

Article 21 of the Rules on medical devices (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 37/10, 66/12) sets out the procedure for the notification of a modification of a performance evaluation study for an in vitro diagnostic medical device.

COSTS OF PROCEDURE

The costs of procedure for the notification of a performance evaluation study for an in vitro medical device or the notification of a modification of such a study are laid down in Article 7 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 the notification of a performance evaluation study for an in vitro diagnostic medical device performance is 530 points.

The fee for the notification of a modification of a performance evaluation study for an in vitro diagnostic medical device performance is 230 points.

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 from 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.

FORMS
  • MedPri-MP-obr05 Application for notification of a performance evaluation study for an in vitro diagnostic medical device
  • MedPri-MP-obr06 Application for notification of a modification of a performance evaluation study for an in vitro diagnostic medical device
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