Theme | Designation code of Notified Bodies |
Target Audience | Notified Bodies, Designating authorities, Manufacturers |
Products Concerned | MD |
Regulatory reference | Commission Implementing Regulation (EU) 2017/2185 of 23 November 2017 on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices under Regulation (EU) 2017/746 of the European Parliament and of the Council
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Documents mentioned |
This guide aims to explain the different levels of NB designation codes listed in Regulation (EU) 2017/2185 and how they should be used.
The guide provides an overview and concrete examples of code assignment according to the nature of the devices.