NBOG documents for Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) The applicability of Best Practice Guides (BPGs) covering requirements set out in the new medical devices Regulations are contingent upon endorsement by the Medical Device Coordination Group (MDCG).

In July 2000, Member States and the European Commission agreed to set up the Notified Body Operations Group (NBOG). This was in response to widespread concern that the performance of Notified Bodies in the medical device sector, and that of the Designating Authorities responsible for them, was variable and inconsistent.

NBOG’s Best Practice Guide applicable for AIMDD, MDD, and IVDD 2014-3 NBOG BPG 2014-3 Page 1 of 19 Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System 1 Introduction The Medical Devices Directives require certain changes of the device or of the quality system to

The Notified Body Operations Group, NBOG, issued a list of codes for the Notified Body’s scope of designation. There is one set of codes for the MDR, NBOG F 2017-3, and another set of codes for the IVDR, NBOG F 2017-4.

Any change of or addition to the scope expressions is subject to NBOG endorsement. The scope expressions consider different requirements of different directives, technologies, use of the devices and the risks associated with the devices.

NBOG’s Best Practice Guide applicable for AIMDD, MDD, and IVDD 2010-1 NBOG BPG 2010-1 Page 1 of 7 Guidance for Notified Bodies auditing suppliers to medical device manufacturers 1 Introduction This document gives guidance to Notified Bodies on …

The Handbook has been produced by the Notified Body Operations Group (NBOG). It draws on a variety of guidance documents produced by various organisations as well as specific material produced by NBOG.

Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System, NBOG's Best Practice Guide

form NBOG F 2017-2 for designation under the IVDR. The content of the application will include a specification of the conformity assessment activities and types of devices to be covered by the designation, using the codes set out in Implementing Regulation (EU) 2017/XX 6 and specified in the corresponding NBOG form

Discover the Qarad library and find NBOG Documents, providing guidance on specific aspects related to the activities of Notified Bodies.