NBOG Documents

In the light of NBOG’s terms of reference – to identify and promulgate examples of best practice to be adopted by both Notified Bodies and those organisations responsible for their designation and control – NBOG has produced the following guideline:

Designating Authorities Handbook    

This Handbook has been designed to be a Best Practice Guide or a practical aid for Designating Authorities and their staff. It provides guidance to authorities on the execution of their responsibilities for the designation, monitoring and control of Notified Bodies in the medical devices sector. It is based on a variety of guidance documents produced by various organisations as well as specific material produced by NBOG. It is anticipated that it will change from time to time as required.

New documents produced by NBOG will be published as documents of

NBOG’s Best Practice Guide

These documents provide guidance on specific aspects related to the activities of Notified Bodies

 Title Publication
NBOG BPG 2006-1 Change of Notified Body
 Nov 2008
NBOG BPG 2009-1Guidance on Design-Dossier Examination and Report Content
 Mar 2009
NBOG BPG 2009-2Role of Notified Bodies in the Medical Device Vigilance System
 Mar 2009
NBOG BPG 2009-3Guideline for Designating Authorities to Define the Notification Scope of a Notified Body Conducting Medical Devices Assessment
 Mar 2009
NBOG BPG 2009-4 Guidance on Notified Body‘s Tasks of Technical Documentation Assessment on a Representative Basis
 Jul 2009
NBOG BPG 2010-1Guidance for Notified Bodies auditing suppliers to medical device manufacturers
 Mar 2010
NBOG BPG 2010-2Guidance on Audit Report Content
 Mar 2010
NBOG BPG 2010-3                                
Certificates issued by Notified Bodies with reference to Council Directives 93/42/EEC, 98/79/EC, and 90/385/EEC Mar 2010

NBOG Checklists

 Title Publication
NBOG CL 2010-1Checklist for audit of Notified Body’s review of Clinical Data/Clinical Evaluation Mar 2010

NBOG Forms

 Title Publication
 NBOG F 2013-1
Application form to be submitted when applying for designation as a notified body (Draft)
 Feb 2014
 NBOG F 2012-1
Notification form – Directive 93/42/EEC Jan 2013
 NBOG F 2012-2
Notification form – Directive 90/385/EEC Jan 2013
 NBOG F 2012-3
Notification form – Directive 98/79/EC Jan 2013
 NBOG F 2010-1Certificate Notification to the Commission and other Member States  Mar 2010

(Probably download required prior to use of the forms)

For comments to the Designating Authorities Handbook and the other NBOG documents or suggestions for amendments, please contact your national NBOG representative or the Chair of NBOG.