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NBOG Documents

 

 

NBOG documents for Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR

Designation and notification of conformity assessment bodies - November 2017

Application form to be submitted by a conformity assessment body when applying for designation as notified body under the medical devices Regulation (MDR) - November 2017

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) - November 2017

Applied-for scope of designation and notification of a Conformity Assessment Body – Regulation (EU) 2017/745 (MDR) - November 2017

Applied-for scope of designation and notification of a Conformity Assessment Body – Regulation (EU) 2017/746 (IVDR) - November 2017

NBOG F 2017-5

Preliminary assessment report form – Regulation (EU) 2017/745

NBOG F 2017-6

Preliminary assessment report form – Regulation (EU) 2017/746

(Re-)designation of notified bodies: Process for joint assessments - June 2016

Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System - November 2014

Guidance on the Information Required for Notified Body Medical Device Personnel Involved in Conformity Assessment Activities - November 2014

Renewal of EC Design-Examination and Type-Examination Certificates: Conformity assessment procedures and general rules - November 2014

Certificates issued by Notified Bodies with reference to Council Directives 93/42/EEC, 98/79/EC, and 90/385/EEC - March 2010

Guidance on Audit Report Content - March 2010

Guidance for Notified Bodies auditing suppliers to medical device manufacturers - March 2010

Guidance on Notified Body‘s Tasks of Technical Documentation Assessment on a Representative Basis - July 2009

Guideline for Designating Authorities to Define the Notification Scope of a Notified Body Conducting Medical Devices Assessment - March 2009

Role of Notified Bodies in the Medical Device Vigilance System - March 2009

Guidance on Design-Dossier Examination and Report Content - March 2009

Change of Notified Body - November 2008

Checklist for audit of Notified Body’s review of Clinical Data/Clinical Evaluation - March 2010

Application form to be submitted when applying for designation as a notified body - November 2014

Qualification of personnel (see NBOG BPG 2014-2) - June 2016

Notification form – Directive 93/42/EEC - January 2013

Notification form – Directive 90/385/EEC - January 2013

Notification form – Directive 98/79/EC - January 2013

Certificate Notification to the Commission and other Member States - March 2010