Designation procedure of a conformity assesment body as a notified body for medical devices

As of 26 November 2017, a conformity assessment body established in the Republic of Slovenia (hereinafter: 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 or Article 34 of the IVDR.

When submitting the application for designation of a conformity assessment body in accordance with the requirements of the MDR, applicant must fulfil all the required fields in Form 1 and submit a complete Form 3 (Applied-for scope of designation and notification of a conformity assessment body – MDR). All necessary evidence of compliance must be submitted in accordance with the requirements of Annex VII of the MDR.

When submitting the application for the designation of a conformity assessment body in accordance with the requirements of the IVDR, applicant must fulfil all the required fields in Form 2 and submit a completed Form 4 (Applied-for scope of designation and notification of a conformity assessment body – IVDR). All necessary evidence of compliance must be submitted in accordance with the requirements of Annex VII of the IVDR.

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

To support the application for designation of a conformity assessment body, 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 documentation.

Upon receiving the application for designation of a conformity assessment body, JAZMP evaluates the application in accordance with Article 39 of the MDR and Article 35 of the IVDR.

After receipt of the application for designation by the conformity assessment body under Article 38 of the MDR or Article 34 of the IVDR, the JAZMP shall, within 30 days, verify if the application is complete. Once JAZMP confirms that the application is complete, the application and all the related documentation will be forwarded and made available to the European Commission. Consequently, JAZMP prepares the preliminary assessment report and submits it to the European Commission for review. Whether an on-site assessment of the conformity assessment body (applicant) is planned depends on the review of the preliminary assessment report by the European Commission.

The on-site assessment of the applicant, the conformity assessment body that has submitted the application, is a joint assessment process between representatives of the authority responsible for notified bodies (JAZMP) and members of the joint assessment team (JAT) of the European Commission, which is composed of national experts and representatives of the European Commission.
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.

Following the on-site assessment of the applicant and after appropriate rectification of the non-compliances of a corrective and preventive action plan, JAZMP draws up its final assessment report and submits it to the JAT and to the Medical Device Coordination Group at the European Commission. If the process for designation of the conformity assessment body continues with the issuance of a recommendation on the designation of the Coordination Group for Medical Devices, JAZMP issues its designation decision and notifies the conformity assessment body as a notified body for medical devices in the NANDO (New Approach Notified and Designated Organisations) database, in accordance with Article 42 of the MDR or Article 38 of the IVDR.

For more information on the designation and notification process, 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 designation and notification of the conformity assessment body, 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 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.