Notified body

GENERAL

In May 2017, the following regulations on medical devices entered into force:

  • Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Regulation (EU) 2017/745 on medical devices; hereinafter: MDR).
  • Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Regulation (EU) 2017/746 on in vitro diagnostic medical devices; hereinafter: IVDR).

As of 26 November 2017, conformity assessment bodies may submit an application for designation to a competent authority under the conditions set out in the aforementioned regulations (see: Designation Procedure).

Following designation and notification, the notified body can submit an application to the competent authority for an extension of the scope of its designation (see: Procedure for Extension of the Scope of Designation). The competent authority may also request that the notified body submit an application for a complete re-assessment (see: Procedure for a Complete Re-assessment).

The requirements for
  • the designation of a conformity assessment body (CAB) as a notified body for medical devices;
  • the extension of the designation scope of a notified body; and for
  • a complete re-assessment of the notified body
are set out in Annex VII of the MDR and Annex VII of the IVDR. These requirements are divided into four categories:
  • organisational and general requirements;
  • quality management requirements;
  • resource requirements;
  • procedure requirements.

In line with the requirements of the MDR and IVDR and considering the timeline of the designation procedure, it is estimated that a minimum of 18 months is needed to complete the process in full. Once the designation and notification procedure has been completed, a notified body may initiate the assessment and certification procedures for medical devices.

For the procedure of assessment and designation, or re-designation, of a notified body, the fee is defined in Article 14 of the JAZMP Tariff for Medical Devices (Official Gazette of the Republic of Slovenia, No. 6/26).

The same Article of the JAZMP Tariff for Medical Devices also provides a fee for the procedure of extending the scope of designation of a notified body, as well as for a notified body’s request for an opinion in accordance with Directive 2001/83/EC.

Notified bodies, in accordance with Article 5 of the JAZMP Tariff for Medical Devices, are also required to pay an annual fee. The entity liable to pay the annual fee for the current year is a notified body established in the Republic of Slovenia and designated in accordance with Regulation (EU) 2017/745 or Regulation (EU) 2017/746. The liable entity is not required to pay the annual fee in the year in which it submits an application for re-designation.

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