What a notified body is and what does it do
A notified body is an organisation designated by an EU Member State (or other countries under specific agreements) to assess the conformity of certain products before being placed on the market.
These bodies are entitled to carry out tasks related to conformity assessment procedures set out in the applicable legislation when a third-party intervention is required.
Designation of a notified body
To be designated, a candidate organisation must fulfil specific requirements on organisational aspects, quality management, resources and processes verified by national authorities responsible for notified bodies with the involvement of other European experts.
The Commission publishes a list of designated notified bodies in the NANDO information system. The information can be filtered by legislation to identify:
- List of notified bodies under Regulation (EU) 2017/745 on medical devices
- List of notified bodies under Regulation (EU) 2017/746 on in vitro diagnostic medical devices
Additional information on the designation process and other aspects related to notified bodies:
- Guidance documents and forms
- Designation process and scheduling of joint assessments: explanatory note
- Notified bodies survey on certifications and applications
- Information on the applications for designation as a notified body - short overview
- Summary on coverage of designation codes for NBs designated under MDR / IVDR
- Commission Implementing Regulation (EU) 2017/2185 of 23 November 2017 set outs the codes for the designation of notified bodies in medical devices under Regulation (EU) 2017/745 and in vitro diagnostic medical devices under Regulation (EU) 2017/746.
Notified Body list of standard fees
In accordance with Article 50 of Regulation (EU) 2017/745 on medical devices and Article 46 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices, notified bodies establish lists of their standard fees for the conformity assessment activities that they carry out and make those lists publicly available.
Notified Body Coordination Group – NBCG-Med
A coordination group of notified bodies in the field of medical devices (NBCG-Med) is established in accordance with Article 49 of Regulation (EU) 2017/745 on medical devices and Article 45 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices.
