Procedure for complete re-assessment of the notified body

The notified body based in the Republic of Slovenia (hereinafter: applicant) shall, upon prior request by JAZMP, submit all necessary documentation for a complete re-assessment of compliance with the requirements set out in Annex VII of the MDR or Annex VII of the IVDR, in accordance with Article 44(10) of the MDR or Article 40(10) of the IVDR.

The applicant shall submit an application for the complete re-assessment accompanied by a cover letter and provide a completed Form 3 or Form 4, in which the conformity assessment activities are specified in accordance with Commission Implementing Regulation (EU) 2017/2185 and the types of devices for which the notified body has already been designated.

The application shall include a list of certificates issued by the notified body, a matrix of authorizations and responsibilities of personnel involved in conformity assessment procedures, and all other quality management system documentation, including the structure of the quality management system, a list of all quality management system documents, and the sequence and traceability/interconnection of processes. The submitted documentation must demonstrate compliance with the requirements of Annex VII of the MDR or Annex VII of the IVDR.

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 documents.

Upon receiving the application for the complete re-assessment of the notified body, 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 the process for complete re-assessment of the notified body, 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 of re-assessment and notification of the applicant, 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 3: Applied-for scope of designation and notification of conformity assessment body – Regulation (EU) 2017/745 (MDR)
• Form 4: Applied-for scope of designation and notification of 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.