As of 26 November 2017, a conformity assessment body established in the Republic of Slovenia (the applicant) may submit an application for designation to the Public Agency of the Republic of Slovenia for Medicinal Products and Medical Devices (JAZMP).
The conformity assessment body must complete Form 1 or Form 2 and provide all necessary evidence of compliance with the requirements of Annex VII of the MDR or Annex VII of the IVDR.
The applicant must also complete Form 3 or Form 4 and enclose it with the application.
Upon receiving an application by a conformity assessment body for designation referred to in Article 38 of the MDR or Article 34 of the IVDR, the JAZMP will, within 30 days of its receipt, verify whether the application is complete. Once the JAZMP has established that the application is complete, the application and all related documentation will be sent and made available to the European Commission. Afterwards, the JAZMP will prepare a preliminary assessment report and submit it to the European Commission for review. The result of the Commission’s review of the preliminary assessment determines whether an on-site assessment of the conformity assessment body (applicant) needs to be conducted.
The on-site assessment of the applicant conformity assessment body is a joint assessment process by representatives of the authority responsible for notified bodies and members of the joint assessment team the European Commission, which consists of national experts and representatives of the European Commission. Following the on-site evaluation of the conformity assessment body and after the implementation of a corrective and preventive action plan to appropriately address the identified non-compliances, the JAZMP draws up its final assessment report and submits the draft designation to the European Commission, the Medical Device Coordination Group and to the joint assessment team. If the procedure for the designation of the conformity assessment body is successful and the Medical Devices Coordination Group issues a recommendation with regard to the draft designation, the JAZMP issues a designation decision. The conformity assessment body is then included in the list of notified bodies for medical devices published on the NANDO website.
For more information about the designation procedure, please refer to the European Commission guidance on designation and notification of conformity assessment bodies.
When applying for designation under the MDR, the applicant must fill in all the required fields in Form 1 and submit a completed Form 3 (Scope of designation and notification of conformity assessment body – MDR).
When applying for designation under the IVDR, the applicant must fill in all the required fields in Form 2 and submit a completed Form 4 (Scope of designation and notification of conformity assessment body – IVDR).
Form 1 or Form 2 must be signed by a relevant representative.
In support of the application for designation, the applicant must provide a list of all documents enclosed in the application.
After checking the completeness of the application, the JAZMP will contact the applicant for designation if it will require additional information.
In the event of any questions, the JAZMP can be contacted by email at .
- Form 1: Application by a conformity assessment body for designation – Regulation (EU) 2017/745 (MDR)
- Form 2: Application by a conformity assessment body for designation – Regulation (EU) 2017/746 (IVDR)
- Form 3: Scope of designation and notification of conformity assessment body – Regulation (EU) 2017/745 (MDR)
- Form 4: Scope of designation and notification of conformity assessment body – Regulation (EU) 2017/746 (IVDR)
COSTS OF PROCEDURE
The fee for the designation of a notified body is defined in Article 6 of the Rules on fees in the field of medical devices (Official Gazette of the Republic of Slovenia, No. 24/19), whereby the fee for the notified body designation procedure in the field of medical devices for the applicant on the day of the commission inspection visit amounts to 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 notice of due payment or the notification on the payment method from the JAZMP.
The 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 the JAZMP.