PROCEDURE FOR THE DESIGNATION OF A CONFORMITY ASSESSMENT BODY AS A NOTIFIED BODY FOR MEDICAL DEVICES

As of 26 November 2017, a conformity assessment body established in the Republic of Slovenia (hereinafter: the applicant) may submit an application for designation to the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP), in accordance with Article 38 of the MDR and Article 34 of the IVDR.

When applying for 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.

When applying for designation in accordance with the IVDR requirements, the 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 – IVDR). They must also provide all the necessary evidence to demonstrate compliance with the requirements under Annex VII to the IVDR.

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

To support their application for the designation of a conformity assessment body, applicants must provide a list of all documents submitted with their 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 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 designation of a conformity assessment body, the JAZMP will assesses it in accordance with Article 39 of the MDR and Article 35 of the IVDR, respectively.

Upon receiving an application for the designation of a conformity assessment body referred to in Article 38 of the MDR or Article 34 of the IVDR, the JAZMP will verify whether the application is complete within 30 days of receipt. Once the JAZMP has confirmed that the application is complete, the application and all related documentation will be sent to and made available to the European Commission. The JAZMP will then produce a preliminary assessment report and submit it to the European Commission for review. The European Commission’s review of the preliminary assessment report will determine whether an on-site assessment of the conformity assessment body (the applicant) is needed.

The on-site assessment of the applicant’s conformity assessment body is a joint assessment process by representatives of the authority responsible for notified bodies (JAZMP) and members of the joint assessment team of the European Commission, which consists of national experts and representatives of the European Commission.

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.

Following the on-site assessment of the applicant and the satisfactory completion of the CAB’s corrective and preventive action (CAPA) plan to appropriately address the identified non-compliances, the JAZMP draws up a final assessment report and submits it to the JAT and the Medical Device Coordination Group (MDCG) at the European Commission. If the procedure for the designation of the conformity assessment body continues with the MDCG issuing a recommendation for designation, the JAZMP then issues a designation decision, designating the conformity assessment body as a notified body for medical devices in the NANDO database (New Approach Notified and Designated Organisations), in accordance with Article 42 of the MDR or Article 38 of the IVDR.

The European Commission website has published the following guideline on the designation and notification procedure: 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 designation and notification procedure for the conformity assessment body, the JAZMP may request that the applicant 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)