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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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