First working documents for designation of Notified Bodies under the Medical Devices Regulation

The Notified Body Operations Group (NBOG) has released draft working documents regarding designation of Notified Bodies, for the preparation of the implementation of Regulation 2017/745 and 2017/746 on Medical Devices and In Vitro Diagnostic Devices.

The first document is a list of requirements that need to be fulfilled by any entity who wants to apply for designation as a Notified Body under the new Regulations on Medical Devices and/or In vitro Devices. Draft application forms have been also created, to be used as a checklist for the application.

The two other documents are proposed lists of codes and corresponding types of devices to be used for specifying the scope of the designation of Notified Bodies.

These documents have not yet been adopted by the European Commission and will be used for the preparation of implementing acts that are expected to be published by the end of November 2017.

Working documents can be consulted on the NBOG website here.

The application forms are available here.