PROCEDURE FOR COMPLETE RE-ASSESSMENT OF THE NOTIFIED BODY
At the prior request of the JAZMP, a notified body established in the Republic of Slovenia (hereinafter: the applicant), must submit all the necessary evidence to enable a complete re-assessment of its compliance with the requirements set out in Annex VII to the MDR or Annex VII to the IVDR, in accordance with Article 44(10) of the MDR or Article 40(10) of the IVDR.
Applicants must submit an application for a full re-assessment, accompanied by a cover letter and either the completed Form 3 or Form 4, specifying the conformity assessment activities in accordance with Commission Implementing Regulation (EU) 2017/2185 and the types of devices for which a notified body has already been designated.
The application must include a list of the notified body’s certificates, a matrix detailing the authorisations and responsibilities of the personnel involved in the conformity assessment procedures and all other quality management system documentation including the management system structure and the list of all quality management system documents, and the sequence and interrelation of procedures; the documentation demonstrating compliance with the requirements of Annex VII to the MDR or Annex VII to the IVDR.
Applicants must send the application by post to the following address: The Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (Javna agencija Republike Slovenije za zdravila in medicinske pripomočke – JAZMP), Slovenčeva ulica 22, 1000 Ljubljana, Republic of Slovenia (Note: JAZMP currently does not have an electronic system for receiving applications.) If the application contains a large volume of documentation, applicants must first arrange a secure method of document delivery with JAZMP.
In accordance with Article 63 of the General Administrative Procedure Act (Official Gazette of the Republic of Slovenia, No. 24/06 – as amended), a written application is an application that is written or printed and signed by hand.
Upon receiving an application for a complete re-assessment, the JAZMP must apply the procedures set out in Articles 39 and 42 of the MDR, or Articles 35 and 38 of the IVDR, as appropriate.
The on-site assessment of the applicant is conducted by the JAZMP in cooperation with the JAT. The composition of the JAZMP and JAT members, the duration of the on-site assessment and its scope vary depending on whether the assessment is part of the designation procedure, an extension of the designation scope, or a complete re-assessment of a notified body.
The European Commission website has published the following guideline on the complete re-assessment of the notified body: MDCG 2022-13 Designation, re-assessment and notification of conformity assessment bodies and notified bodies
In the course of verifying the completeness of the application, as well as throughout the entire re-assessment procedure, the JAZMP may request the applicant to provide supplementary information or clarifications, in order to obtain further details.
For any further enquiries, the JAZMP may be contacted by email at .
