The Medical Device Coordination Group ('MDCG'), a body established under Article 103 of Reg. 745/2017, which provides advice and develops guidance in the medical device sector, has approved the Guidelines for the assessment of notified bodies (MDCG 2022-13 Designation, reassessment and notification of conformity assessment bodies and notified bodies - August 2022).

The document provides guidance to National Authorities responsible for Notified Bodies (in Italy, the Ministry of Health) and to Joint Assessment Teams ('JATs', consisting of representatives of the EU Commission and national experts) in carrying out the assessment processes of Conformity Assessment Bodies ('CABs') seeking designation as Notified Bodies ('NBs') in the medical device sector, and the reassessment processes of NBs.

The aim of the Guidelines is to align and make consistent with each other the working practices of the National Authorities regarding the evaluation, designation, notification and re-evaluation of CABs and NBs, in accordance with the provisions of the European Medical Device Regulations (Reg. 745/2017, "MDR" and Reg. 746/2017, "IVDR").

In particular, the different steps foreseen for the CAB assessment and NB reassessment processes are outlined, identifying the documentation to be submitted, the timelines to be met, as well as the authorities involved and their tasks.

At the end of the document, two flowcharts are made available that provide, for each procedure, a useful summary on the steps to be followed and an estimated duration for each step (the Guidelines are available at the following link: https://health.ec.europa.eu/latest-updates/mdcg-2022-13-designation-re-assessment-and-notification-conformity-assessment-bodies-and-notified-2022-08-10_en).