Which is the Italian medical device registration review body
EU Notified Body. The EU Notified Body is an important technical entity in the EU for the implementation of market access management in accordance with the New Approach Directive. In order to harmonize and coordinate third-party certification, on April 25, 1990, the European **** body, the European Free Trade Area, CEN and CENELEC signed an agreement in Brussels to establish the "European Organization for Testing and Certification (EOTC)". These organizations are known as Notified Bodies and their role is to assess the compliance of products with the relevant legislation in force. The Italian Accreditation Body for the Registration of Medical Devices is an EU Notified Body.