EU: NBOG publishes a best practice guide to notification in accordance with the MDR and IVDR

The Notified Body Operations Group of the EU has published a guide to best practice, which explains the steps involved in notification and conformity assessment for notified bodies in accordance with the European regulations on medical devices (2017/745 MDR) and in-vitro diagnostics (2017/746 IVDR). This guide contains information on the process of notification, as well as an overview of planned activities and currently estimated timelines in Appendix I.

Go back