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

 Number Title Publication
NBOG BPG 2016-1
(Re-)designation of notified bodies: Process for joint assessments
Jun 2016
NBOG BPG 2014-3Guidance for manufacturers and Notified Bodies on reporting of
Design Changes and Changes of the Quality System
Nov 2014
NBOG BPG 2014-2Guidance on the Information Required for Notified Body Medical Device Personnel Involved in Conformity Assessment Activities
Nov 2014
NBOG BPG 2014-1Renewal of EC Design-Examination and Type-Examination Certificates: Conformity assessment procedures and general rules
Nov 2014
NBOG BPG 2010-3Certificates issued by Notified Bodies with reference to Council Directives 93/42/EEC, 98/79/EC, and 90/385/EECMar 2010
NBOG BPG 2010-2Guidance on Audit Report Content
Mar 2010
NBOG BPG 2010-1Guidance for Notified Bodies auditing suppliers to medical device manufacturersMar 2010
NBOG BPG 2009-4 Guidance on Notified Body‘s Tasks of Technical Documentation Assessment on a Representative BasisJul 2009
NBOG BPG 2009-3
Guideline for Designating Authorities to Define the Notification Scope of a Notified Body Conducting Medical Devices Assessment

Note: Please note that the current scope expressions (MD / MDS codes) can be found in the respective notification forms below. 
Mar 2009
NBOG BPG 2009-2Role of Notified Bodies in the Medical Device Vigilance System Mar 2009
NBOG BPG 2009-1Guidance on Design-Dossier Examination and Report Content
Mar 2009
NBOG_BPG_2006-1Change of Notified Body
Nov 2008

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 2014-1
Application form to be submitted when applying for designation as a notified body
Nov 2014
NBOG_F 2014-2
Qualification of personnel (see NBOG BPG 2014-2)

Note: After filling in the applicant but before handing it out to the personnel the form needs to be protected with a password to prevent changes. (See Microsoft support on the internet for instructions.)

This document includes editorial changes made in 06/2016!
Jun 2016
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.