Notification, review and conclusion of a clinical investigation

A) CLINICAL INVESTIGATIONS CONDUCTED TO DEMONSTRATE CONFORMITY OF DEVICES

Determining whether a clinical investigation conducted to demonstrate conformity of devices referred to in Article 62 of the MDR falls within the scope of this regulation and whether an application dossier is complete in accordance with Chapter II of Annex XV of the MDR, and notifying the sponsor in accordance with Article 70(5) of the MDR (application validation date) is the responsibility of the JAZMP.

An application for a clinical investigation must include:

Within a set period from the validation date, the JAZMP must carry out an assessment of the application in accordance with Article 71 of the MDR.

In the republic of Slovenia, the sponsor may start the clinical investigation of the devices:
  • referred to in point (a) of Article 70(7) of the MDR, as soon as the JAZMP has notified the sponsor of its authorisation and provided that the KME RS has not issued a negative opinion;
  • referred to in point (b) of Article 70(7) of the MDR, as soon as the JAZMP has notified the sponsor of its authorisation and provided that the KME RS has not issued a negative opinion;
B) SUBSTANTIAL (AND NON-SUBSTANTIAL) MODIFICATIONS OF CLINICAL INVESTIGATIONS

A substantial modification of a clinical investigation is any change to the clinical investigation which is likely to have a substantial impact on the safety, health or rights of the subject, or on the robustness or reliability of clinical data generated by the investigation.

Substantial modifications of clinical investigations (Article 75 of the MDR) must be notified to the JAZMP by completing the form Clinical investigation – Substantial modification of clinical investigation under Medical Device Regulation (Notification form Version 1.1), which is available at the link: MDCG 2021-28 Substantial modification of clinical investigation under Medical Device Regulation, and by sending it by email to . The above applies until the Clinical investigations module is made available in the European Database on Medical Devices (EUDAMED).

In case of doubt as to whether a proposed modification is substantial or non-substantial, please consult the guidance MDCG 2021-6 Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation, referring to Annex II at the end of the document – Annex II: Non-exhaustive list of modifications that may be interpreted as substantial.

The notified modification may be implemented if the JAZMP or the KME RS has not issued a negative opinion within 38 days of notification of the modification.

C) CLINICAL INVESTIGATIONS REGARDING DEVICES BEARING THE CE MARKING

If a sponsor intends to conduct a clinical investigation to further asses, within its intended purpose, a device already bearing the CE marking and if the investigation involves submitting subjects to invasive or burdensome procedures additional to those performed under the normal conditions of use of the device, the sponsor is required to notify the JAZMP.

Where notification to the JAZMP is required, the sponsor must complete the Clinical investigation application form under Medical Device Regulation (Application form version 1.0), available at the link MDCG 2021-08 Clinical investigation application/notification documents, and send it together with the relevant documents to .

EXAMINATION PROCEDURE FOR INVESTIGATIONS CONDUCTED TO DEMONSTRATE THE CONFORMITY OF DEVICES

Upon receiving an application for a clinical investigation of a medical device, the JAZMP must first determine whether the proposed clinical investigation falls within the scope of the MDR and verify that all the required documentation referred to in Chapter II of Annex XV thereto has been submitted and that the application dossier is complete. Within 10 days of receiving the application, the JAZMP must notify the sponsor as to whether the clinical investigation falls within the scope of the MDR and as to whether the application dossier is complete in accordance with Chapter II of Annex XV thereto.

Once the clinical investigation application has been validated, i.e. once the sponsor has been notified, the sponsor may start the clinical investigation:
  • In the case of Class I devices or non-invasive Class IIa and Class IIb devices, immediately after the validation date of the application, provided that KME RS has not issued a negative opinion in respect of the clinical investigation. During the period when the application is being assessed, the JAZMP or the KME RS may request additional information from the sponsor.
  • In the case of invasive devices or Class III devices, immediately after the notification of authorisation, provided that KME RS has not issued a negative opinion in respect of the clinical investigation. The JAZMP will notify the sponsor of the authorisation within 45 days of the validation date. Where the JMAAP needs to consult experts during the assessment, this period may be extended by a further 20 days.
EXAMINATION PROCEDURE FOR OTHER CLINICAL INVESTIGATIONS

The sponsor of a clinical investigation referred to in Article 82 of the MDR must send an application accompanied by the relevant documents to the JAZMP by email to: .

The dossier application must include:
  • the application form referred to in Section 1 of Chapter II of Annex XV to the MDR, containing information under points 1.1 to 1.4, 1.6, 1.9, 1.11, 1.14 and 1.16;
  • the information referred to in sections 4.3, 4.4 and 4.5 of Chapter II of Annex XV to the MDR;
  • a clinical investigation plan containing information referred to in Section 3 of Chapter II of Annex XV to the MDR.

The sponsor may start the clinical investigation of devices immediately after the validation date of the application, provided that the KME RS has not issued a negative opinion and the JAZMP has not refused the authorisation of the clinical investigation for the reasons set out in Article 71(4) of the MDR.

CONCLUSION OR SUSPENSION OF A NOTIFIED CLINICAL INVESTIGATION

The sponsor conducting a clinical investigation in the Republic of Slovenia must notify the JAZMP of its conclusion within 15 days of the end of the clinical investigation.

Within one year of the end of the clinical investigation, the sponsor must submit to the JAZMP a clinical investigation report as referred to in Section 2.8 of Chapter I and Section 7 of Chapter III of Annex XV to the MDR. If the clinical investigation was temporarily halted or terminated early, the clinical investigation report must be submitted to the JAZMP within three months from the date of temporary halt or early termination. The clinical investigation report must be accompanied by a summary presented in terms that are easily understandable to the intended user.

Until the EUDAMED CI module is made available, sponsors must submit the above-mentioned notification and report by email to: .

COSTS OF PROCEDURE

For the procedures set out in the MDR, the applicant must pay a fee to the JAZMP. The JAZMP sends a notification on the payment method to the email address indicated by the applicant in the application form.

The fee becomes subject to payment after the receipt of the notice of due payment or the notification on the payment method from the JAZMP. 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.

The fee for an application for a clinical investigation and an application for a substantial modification of a clinical investigation is charged in accordance with the Rules on fees in the field of medical devices (Official Gazette of the Republic of Slovenia, No. 24/19).

FORMS
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