A) CLINICAL INVESTIGATIONS CONDUCTED TO DEMONSTRATE CONFORMITY OF DEVICES
The JAZMP is responsible for 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 the application dossier is complete in accordance with Chapter II of Annex XV to the MDR. The JAZMP is also responsible for notifying the sponsor in accordance with Article 70(5) of the MDR (application validation date).
- A cover letter containing basic information on the application and the applicant;
- The completed form Clinical investigation – application form under Medical Device Regulation (Application form version 1.0) – available in MDCG 2021-08 Clinical investigation application/notification documents in Slovenian;
- All required documentation in accordance with Chapter II of Annex XV to the MDR;
- The email address and payment details (payer’s name, address) for issuing the fee payment notification.
- The labelling and instructions for use (IFU), as referred to in Section 23 of Annex I to the MDR, intended for the lay person, including the information specified in Article 18(1) of the MDR;
- An overall synopsis of the clinical investigation, as referred to in Section 3.1.5 of Chapter II of Annex XV to the MDR; and
- Documents to be used to obtain informed consent, as referred to in Section 4.4 of Chapter II of Annex XV to the MDR.
Within a set period from the validation date, the JAZMP and the KME RS must carry out an assessment of the application in accordance with Article 71 of the MDR.
- referred to in Article 70(7)(a) of the MDR immediately after the validation date and provided that the KME RS has not issued a negative opinion;
- referred to in Article 70(7)(b) of the MDR, as soon as the JAZMP has notified the sponsor of its authorisation of the clinical investigation and provided that the KME RS has not issued a negative opinion.
B) SUBSTANTIAL (AND NON-SUBSTANTIAL) MODIFICATIONS TO CLINICAL INVESTIGATIONS
A substantial modification to a clinical investigation means 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 to clinical investigations (Article 75 of the MDR) must be notified to the JAZMP using the Clinical investigation – Substantial modification of clinical investigation under Medical Device Regulation form (Notification form Version 1.1), which is available in MDCG 2021-28 Substantial modification of clinical investigation under Medical Device Regulation, 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 the modification being notified.
Article 25 of the Medical Devices Act (ZMedPri-1) applies mutatis mutandis to substantial modifications to clinical investigations referred to in Articles 62 and 74 of the MDR, with regard to the validation or assessment of an application for such a substantial modification, and to the KME RS’s submission of an opinion on the substantial modification to the clinical investigation.
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 in addition 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 in MDCG 2021-08 Clinical investigation application/notification documents, and send it together with the relevant documents.
REVIEW PROCEDURE FOR CLINICAL 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. The JAZMP must notify the sponsor of the above within 10 days of receiving the application.
- 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 the KME RS has not issued a negative opinion regarding 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 the KME RS has not issued a negative opinion regarding the clinical investigation. The JAZMP must notify the sponsor of the authorisation within 45 days of the validation date. If the JAZMP needs to consult experts during the assessment, this period may be extended by a further 20 days.
REVIEW PROCEDURE FOR OTHER CLINICAL INVESTIGATIONS OF MEDICAL DEVICES
The sponsor of a clinical investigation referred to in Article 82 of the MDR must notify the JAZMP of the investigation. The notification must be accompanied with the following:
- the application form referred to in Chapter II of Annex XV to the MDR, containing the information required under Sections 1.1, 1.2, 1.3, 1.4, 1.6, 1.9, 1.11, 1.14 and 1.16;
- the information required under Sections 4.3, 4.4 and 4.5 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.
As the JAZMP does not currently have such an information system in place, notifications must be submitted in person at the JAZMP head office or sent by post, in accordance with paragraph two of Article 63 of the General Administrative Procedure Act (ZUP).
END OR SUSPENSION OF A NOTIFIED CLINICAL INVESTIGATION
A sponsor conducting a clinical investigation in Slovenia must notify the JAZMP of its completion within 15 days of the end of the clinical investigation.
Within one year of the end of the clinical investigation, the sponsor must submit a clinical investigation report to the JAZMP 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 report must be accompanied by a summary written in language that is easily understandable to the intended user.
Until the EUDAMED CI module is made available, sponsors must submit the aforementioned notification and report by email to: .
PROCEDURE COSTS
Applicants must pay a fee to the JAZMP for the procedures set out in the MDR. The JAZMP will send a notification of the payment method to the email address provided 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 of the payment method from the JAZMP. Applicants 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 of the payment method. If the fee is not paid, the JAZMP may charge the applicant or the liable person statutory default interest.
Fees for applications relating to clinical investigations and substantial modifications to clinical investigations are charged in accordance with the JAZMP Tariff for the field of medical devices (Official Gazette of the Republic of Slovenia, [Uradni list RS], No. 6/26)
FORMS
- Clinical investigation – application form under Medical Device Regulation (Application form version 1.0)
- Addendum to the clinical investigation application/notification form:
- Clinical investigation – Substantial modification of clinical investigation under Medical Device Regulation (Notification form Version 1.1).
