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:
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
|NBOG BPG 2016-1||(Re-)designation of notified bodies: Process for joint assessments||Jun 2016|
|NBOG BPG 2014-3||Guidance for manufacturers and Notified Bodies on reporting of |
Design Changes and Changes of the Quality System
|Nov 2014 |
|NBOG BPG 2014-2||Guidance on the Information Required for Notified Body Medical Device Personnel Involved in Conformity Assessment Activities ||Nov 2014|
|NBOG BPG 2014-1||Renewal of EC Design-Examination and Type-Examination Certificates: Conformity assessment procedures and general rules||Nov 2014|
|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 BPG 2010-2||Guidance on Audit Report Content ||Mar 2010|
|NBOG BPG 2010-1||Guidance for Notified Bodies auditing suppliers to medical device manufacturers||Mar 2010|
|NBOG BPG 2009-4||Guidance on Notified Body‘s Tasks of Technical Documentation Assessment on a Representative Basis||Jul 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.
|NBOG BPG 2009-2||Role of Notified Bodies in the Medical Device Vigilance System||Mar 2009|
|NBOG BPG 2009-1||Guidance on Design-Dossier Examination and Report Content ||Mar 2009|
|NBOG_BPG_2006-1||Change of Notified Body ||Nov 2008|
|NBOG CL 2010-1||Checklist for audit of Notified Body’s review of Clinical Data/Clinical Evaluation|| Mar 2010|
| Number ||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!
|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 2010-1||Certificate 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.