Public consultation on Notified Body Codes Implementing Regulation opens

Posted on 28.09.2017

The European Commission has published a draft implementing Regulation on the notified body scope designation codes for IVDs and for MDs. This draft implementing Regulation is open for public consultation until 25 October 2017 (4 week commenting period). These documents (implementing Regulation and its annexes) can be found by clicking on this link.

The documents provide the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices (Annex I) and IVDs (Annex II). Notified bodies shall use the lists of codes and corresponding types of devices set out in Annexes I and II to this Regulation when specifying the types of devices in the application for designation referred to in Article 38 of Medical Devices Regulation 2017/745/EU and Article 34 of In Vitro Diagnostic Medical Devices Regulation 2017/746/EU.

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