Procedure for extending the scope of the designation of the notified body

An application for the procedure for extending the scope of designation shall be submitted by the notified body, established in the Republic of Slovenia (hereinafter: applicant), to the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP), in accordance with Article 46 of the MDR or Article 42 of the IVDR.

When submitting the application for extending of the scope of the designation, in accordance with the requirements of the MDR, the applicant shall complete required fields in Form 1 and submit a completed Form 3 (Applied-for scope of designation and notification of the conformity assessment body – MDR).

The applicant shall provide all necessary evidence of compliance with the requirements of Annex VII of the MDR, specifically limited to the information of the extension of the scope of designation, indicating, for example, new/additional conformity assessment procedures and/or new types of devices within the scope of designation according to Commission Implementing Regulation (EU) 2017/2185 and relevant changes in the quality management system of the notified body.

When submitting the application for extending of the scope of the designation, in accordance with the requirements of the IVDR, the applicant shall complete the required fields in Form 2 and submit a completed Form 4 (Applied-for scope of designation and notification of the conformity assessment body – IVDR).

The applicant shall provide all necessary evidence of compliance with the requirements of Annex VII of the IVDR, specifically limited to the information of the extension of the scope of designation, indicating, for example, new/additional conformity assessment procedures and/or new types of devices within the scope of designation according to Commission Implementing Regulation (EU) 2017/2185 and relevant changes in the quality management system of the notified body.

Form 1 or Form 2 must be signed by the authorized representative as indicated in the business register.

To support the application in the procedure for extending the scope of the designation, in addition to the attached relevant documents/evidence, the applicant shall provide a list of all documents submitted in the application.

The applicant is obliged to send the application by regular post to the address: Agency for Medicinal Products and Medical Devices of the Republic of Slovenia, Slovenčeva ulica 22, 1000 Ljubljana, Republic of Slovenia (JAZMP does not currently have an electronic system for accepting applications). In the case of a large number of documents in the application, the applicant shall contact JAZMP in advance regarding the agreement on the safe way of delivering the documentation.

Upon receiving the application in the procedure for extending of the scope of the designation under Article 46 of the MDR or Article 42 of the IVDR, JAZMP will accordingly follow the procedures from Article 39 and 42 of the MDR or Articles 35 and 38 of the IVDR.

The on-site assessment of the applicant is conducted by JAZMP in cooperation with the JAT. The representation of JAZMP and the JAT members, the duration of the on-site assessment procedure and the content of the assessment differs depending on the assessment that is part of the applicant’s designation process or process for extending the scope of the designation or the complete re-assessment of the notified body.

For more information on processes for extending the scope of the designation, the guideline MDCG 2022-13 Designation, re-assessment and notification of conformity assessment bodies and notified bodies is available on the European Commission website.

During the verification of the completeness of the application and throughout the entire process for extending the scope of the designation and notification, JAZMP shall, if needed, in order to obtain further information, request the applicant for additional documentation or clarification.

In the case of additional questions, JAZMP can be contacted by email address: .

FORMS

• Form 1: Application form for designation of a conformity assessment body – Regulation (EU) 2017/745 (MDR)
• Form 2: Application form for designation of a conformity assessment body – Regulation (EU) 2017/746 (IVDR)
• Form 3: Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/745 (MDR)
• Form 4: Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/746 (IVDR)

COSTS OF THE PROCEDURE

For the designation procedure of a notified body, the fee is specified in Article 6 of the Rules on fees in the field of medical devices (Official Gazette of the Republic of Slovenia, No. 24/19). The fee for the notified body designation procedure in the field of medical devices therefore will be charged on the day of the commission inspection visit according to Rules on fees in the field of medical devices by 910 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 notification of due payment or the notification on the payment method by JAZMP.

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 JAZMP.