General

Clinical investigation of a medical device means assessment of its safety and performance in compliance with the intended use as indicated by the manufacturer.The safety and performance of in vitro diagnostic medical devices (IVD) is established on the basis of performance evaluation studies.

Clinical investigations of medicinal devices or performance evaluationstudies of in vitro diagnostic medicinal devices (IVD) are carried out for medicinal devices that do not bear the CE marking. 

Clinical investigations or performance evaluation studies are also carried out on medical devices that have already obtained the CE marking, when the aim of these investigations and studies is to use the device for a purpose other than that referred to in the relevant conformity assessment procedure.The manufacturer of the medicinal device or his authorised representative (hereinafter: the applicant) notifies the clinical investigation of a medicinal device or the performance evaluation study of an in vitro medicinal device by submitting an application at JAZMP. JAZMP decides on the notification within 60 days from the date of receiving the application, and issues a decision. Clinical investigation of a medicinal device or performance evaluation study of an in vitro diagnostic medicinal devices may start when the positive decision is final.

Notification procedure

Notification of a clinical investigation of a medicinal device

The applicant for notifying the clinical investigation submits an application in printed or electronic form, signed with a secure electronic signature with a qualified certificate, on the form MedPri-MP-obr03, and also on form Annex A MedPri-MP-obr03 if relevant, and submits the required documentation as stipulated by the form. If the form is incomplete, JAZMP must request an amendment of the form within 30 days and set a deadline for the applicant in which he must supplement it.

The applicant may decide to change the clinical investigation of a medicinal device at any time. For any change, a written or electronic application is submitted, signed with a security electronic signature with a qualified certificate, on the form MedPri-MP-obr04. Notified changes may be implemented only if JAZMP does not issue a negative decision about the change within 30 days from the complete application being submitted.

Ongoing clinical investigation of a medicinal device

The applicant must notify JAZMP about adverse events with a medicinal device during the clinical investigation no later than seven days from the event. Detailed information and guidelines on when and how to report are available at the link to the guidelines of the European Commission “Clinical investigations: serious adverse reporting under directives 90/385/EEC and 93/42/EC” MEDDEV 2.7/3.

Completion or halt of a notified clinical investigation

The applicant of the notified clinical investigation of a medicinal device must inform JAZMP about the completion and submit a final report within 30 days from the completion. The applicant may also decide to halt the clinical investigation at any time, and should notify JAZMP about the reasons for halt within 15 days from the day of halt.

Notification of a performance evaluation study of an in vitro medicinal device

The applicant for notifying a performance evaluation study about a clinical investigation, submits an application in printed or electronic form, signed with a secure electronic signature with a qualified certificate, on the form MedPri-MP-obr05 and submits the required documentation as stipulated by the form . If the form is incomplete, JAZMP must request an amendment of the form within 30 days and set a deadline for the applicant in which he must supplement it.

The applicant may decide to change the performance evaluation study of an in vitro medicinal device at any time. For any change a written or electronic application is submitted, signed with a security electronic signature with a qualified certificate on the form MedPri-MP-obr06. Notified changes may be implemented only if JAZMP does not issue a negative decision about the change within 30 days from the complete application being submitted.

Costs of the procedure

The costs of the procedure for notifying a clinical investigation of medicinal devices or its changes or notification of a performance evaluation study of an in vitro medicinal devices or its changes are defined in Article 8 of the Rules on fees in the field of medicinal devices (Official Gazette of the Republic of Slovenia, No. 37/10). 

The fees for the procedure of notifying a clinical investigation of medicinal devices are as follows:  

  • for notification of a clinical investigation of class I and IIa medical devices – 200 points;
  • for notification of a clinical investigation of class IIb and III medical devices and active implantable medical devices – 300 points. 

The fee for the procedure of notification of a change of clinical investigation of class IIa, IIb, III medical devices and active implantable medical devices is 100 points.

The fee for the procedure of notification of a study for the evaluation of in vitro diagnostic medical device performance is 100 points.

The fee for the procedure of notification of a change of study for the evaluation of in vitro diagnostic medical device performance is 50 points.The fees are specified in points. Point value is EUR 5. The amount of the fee is the point value multiplied by the number of points.

After reviewing the application, JAZMP sends a notice on the payment of a fee to the applicant with all information required for payment.