PROCEDURE FOR THE EXTENSION OF THE SCOPE OF THE DESIGNATION OF A NOTIFIED BODY

A conformity assessment body established in the Republic of Slovenia (hereinafter: the applicant) submits an application for the extension of the scope of designation to the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP) in accordance with Article 46 of the MDR and Article 42 of the IVDR.

When applying for an extension of the scope of designation in accordance with the MDR requirements, applicants must complete all the required fields in Form 1 and submit a completed Form 3 (Scope of Designation and Notification of Conformity Assessment Body – MDR). They must also provide all the necessary evidence to demonstrate compliance with the requirements of Annex VII to the MDR relating to the relevant information required for an extension of the designation scope. This includes, for example, the specification of any new or additional conformity assessment procedures and/or new types of devices within the scope of the designation, as set out in Implementing Regulation 2017/2185/EU, and any corresponding changes to the notified body’s quality management system.

When applying for the extension of the scope of designation in accordance with the IVDR requirements, applicants must complete all the required fields in Form 2 and submit a completed Form 4 (Scope of Designation and Notification of Conformity Assessment Body – MDR). They must also provide all the necessary evidence to demonstrate compliance with the requirements of Annex VII to the IVDR relating to the relevant information required for an extension of the designation scope. This includes, for example, the specification of any new or additional conformity assessment procedures and/or new types of devices within the scope of the designation, as set out in Implementing Regulation 2017/2185/EU, and any corresponding changes to the notified body’s quality management system.

Forms 1 and 2 must be signed by an authorised representative, as recorded in the business register.

To support their application for the extension of the designation scope, applicants must provide a list of all documents submitted with the application, in addition to the required documentation and evidence.

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 the 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 the extension of the scope of designation referred to in Article 46 of the MDR or Article 42 of the IVDR, 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 procedure for the extension of the designation: 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 procedure for the extension of the designation scope, the JAZMP may request the applicant to provide supplementary information or clarifications, as required, to obtain further details.

For any further enquiries, the JAZMP may be contacted by email at .

• Form 1: Application by a conformity assessment body for designation – Regulation 2017/745/EU (MDR)
• Form 2: Application by a conformity assessment body for designation – Regulation 2017/746/EU (IVDR)
• Form 3: Scope of Designation and Notification of Conformity Assessment Body – Regulation 2017/745/EU (MDR)
• Form 4: Scope of Designation and Notification of Conformity Assessment Body – Regulation 2017/746/EU (IVDR)