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
These documents provide guidance on specific aspects related to the activities of Notified Bodies
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 particular where its involvement is referred to in these BPGs, it must be emphasised that the MDCG should ultimately agree on the relevant steps and deadlines.
On this website only versions with approval at Competent Authorities meetings before the establishment of the MDCG are presented. For documents having been endorsed by the MDCG please see https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en, section MDCG documents.
|NBOG BPG 2017-1 rev.1||Designation and notification of conformity assessment bodies||Nov 2017|
|NBOG F 2017-1 rev.2
||Application form to be submitted by a conformity assessment body when applying for designation as notified body under the medical devices Regulation (MDR)||Nov 2017
|NBOG F 2017-2 rev.2
||Application form to be submitted by a conformity assessment body when applying for designation as notified body under the in vitro diagnostic devices Regulation (IVDR)||Nov 2017|
|NBOG F 2017-3||Applied-for scope of designation and notification of a Conformity Assessment Body – Regulation (EU) 2017/745 (MDR)||Nov 2017|
|NBOG F 2017-4||Applied-for scope of designation and notification of a Conformity Assessment Body – Regulation (EU) 2017/746 (IVDR)||Nov 2017|
|NBOG F 2017-5||Preliminary assessment report form – Regulation (EU) 2017/745||tbt|
|NBOG F 2017-6||Preliminary assessment report form – Regulation (EU) 2017/746||tbt|
|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
|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|
|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.
These documents provide guidance on specific aspects related to the activities of Notified Bodies.
Please note that hyperlinks contained in the following documents are valid only when the documents are published. Subsequent changes of such links will not be updated.