APPLICATION FOR PERFORMANCE STUDY
- documentation from sections 2 and 3 of Annex XIII and Annex XIV of the IVDR;
- positive opinion of the KME RS;
- email address for sending the fee payment notification.
SUBSTANTIAL (AND NON-SUBSTANTIAL) MODIFICATIONS OF PERFORMANCE STUDIES
If a sponsor intends to introduce modifications to a performance study that are likely to have a substantial impact on the safety, health or rights of the subjects or on the robustness or reliability of the data generated by the study, it shall notify, within one week, the JAZMP of the reasons for and the nature of those modifications. The sponsor shall include an updated version of the relevant documentation referred to in Annex XIV as part of the notification. Changes to the relevant documentation shall be clearly identifiable.
Regarding the modification of the performance study, an application shall be submitted in paper form, personally signed, on a form (in preparation) and appropriate documentation, which will contain a description and justification of the modifications and their potential impact on the performance, effectiveness, safety or other endpoints, and identification of the affected documents. It should be noted that prior to the implementation of any proposed modifications, a review and positive opinion from the KME RS may also be required.
Substantial modifications to performance evaluation studies approved in accordance with Directive 98/79/EC on in vitro diagnostic medical devices (hereinafter: IVDD) must follow the IVDD procedure for approval of the modification, even after May 26 2022, on the form:
MedPri-MP-06 Application for notification of a modification of a performance evaluation study for an in vitro diagnostic medical device
PERFORMANCE STUDY NOTIFICATIONS
A performance study notification to the JAZMP consists of the following:
- a completed notification form for Article 58(2) IVDR (in preparation);
- a completed notification form for Article 70(1) IVDR (in preparation);
- any additional required documentation, where relevant;
- email address for sending the fee payment notification.
PROCESS FOR REVIEW OF PERFORMANCE STUDIES APPLICATIONS
On receipt of an application to undertake a performance study, the application is validated to check that all the required documentation is present and that the proposed performance study falls within the scope of the IVDR.
At that time, a JAZMP reference number is assigned to the application, and this should be quoted in all future correspondence with the JAZMP. All performance studies undertaken in Europe should also be assigned a unique identification number CIV ID, which is used for all relevant communication regarding the performance study. If you have already been issued with a CIV ID for the same performance study being conducted in another Member State, please provide this to the JAZMP on the application form.
The sponsor may start the performance study in the following circumstances:
- in the case of performance studies carried out pursuant to point (a) of Article 58(1) IVDR and where the specimen collection does not represent a major clinical risk to the subject of the study, immediately after the validation date of application by JAZMP, provided that a negative opinion has not been issued by the KME RS in respect of the performance study.
The date on which the sponsor is notified if the performance study falls within the scope of this Regulation, shall be considered the validation date of the application. Where the sponsor is not notified, the validation date shall be the last day of the periods referred to in paragraphs 1, 3 and 4 of Article 66 of the IVDR.
For studies where the specimen collection does not represent a major clinical risk, a detailed justification must be provided in the application form. The JAZMP may request additional clarifications from the sponsor in relation to any justification provided as part of the dossier completeness check outlined in Article 66 of the IVDR.
- all other performance studies (interventional clinical performance studies; where the conduct of the study involves additional invasive procedures or other risks for the subjects of the studies; performance studies involving companion diagnostics) cannot be started until the sponsor has been notified of the JAZMP authorization in accordance with Article 66(7b) IVDR and provided that a negative opinion has not been issued by the KME RS in respect of the performance study.
After validation of an application the JAZMP will assess and provide an outcome of its assessment within 45 calendar days. Where the JAZMP needs to consult with an expert during the period of assessment, an additional 20 calendar days is added to the time available for assessment by the JAZMP. During the assessment period, the JAZMP may request additional information from the sponsor of the performance study. Any time taken by the sponsor to provide this additional information is not included within the assessment timeframe described above. This process applies to all risk classes of in vitro diagnostic medical devices: Class A to D.
Where a response is not provided to the issues raised by the JAZMP within the timeframe this may result in rejection or refusal of the application due to incomplete data being available to support the application.
The above also applies to performance studies of in vitro diagnostic medical devices which already bear a CE mark, but the performance study is outside the scope of the intended purpose of use (Article 70(2) of the IVDR).
REFUSAL OF AUTHORISATION OF A PERFORMANCE STUDY
The JAZMP may refuse to authorise the performance study if, after consideration of all the evidence provided by a manufacturer or sponsor, the grounds for authorisation of the performance study are not met or there are grounds for refusal, according to Article 67(4) of the IVDR.
CONCLUSION OR SUSPENSION OF PERFORMANCE STUDY
The sponsor conducting a performance study in the Republic of Slovenia must notify the JAZMP of its conclusion within 15 days of the end of the performance study.
Within one year of the end of the performance study, the sponsor must submit to the JAZMP a performance study report as referred to in Section 2.3.3 of Part A of Annex XIII to the IVDR. If the performance study was temporarily halted or terminated early, the performance study report must be submitted to the JAZMP within three months from the date of temporary halt or early termination. The performance study report must be accompanied by a summary presented in terms that are easily understandable to the intended user.
Until the EUDAMED modules are fully functional, the JAZMP expects sponsors to submit the above-mentioned notification and report by email to: , along with the JAZMP reference number assigned to the performance study.
COSTS OF PROCEDURE
The fee for an application for a performance study and an application for a substantial modification of a performance study is charged in accordance with Article 7 of the Rules on fees in the field of medical devices (Official Gazette of the Republic of Slovenia, No. 24/19).
The fee for notification of a performance study of an in vitro diagnostic medical device is 530 points.
The fee for notification of a modification of a performance study of an in vitro diagnostic medical device is 230 points.
The fees are specified in points. The value of one point is 5 euros without value added tax (VAT). The amount of the fee is the product of the point value and the number of points.
The applicant shall pay the fee upon receipt of the JAZMP’s request for payment or notification of the method of payment of the fee.
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. When settling the fee, the applicant or the person liable must use the reference number indicated in the notice of due payment or the notification on the payment method. In the case of non-payment of the fee, the JAZMP may charge statutory default interest to the applicant or the person liable.