MDR - Chapter IV - article 43

Original text

Expert opinion

Identification number and list of notified bodies

1. The Commission shall assign an identification number to each notified body for which the notification becomes valid in accordance with Article 42(11). It shall assign a single identification number even when the body is notified under several Union acts. If they are successfully designated in accordance with this Regulation, bodies notified pursuant to Directives 90/385/EEC and 93/42/EEC shall retain the identification number assigned to them pursuant to those Directives.


The ID of a NB

For every Notfied Body (NB) being designated in accordance with the MDR 2017/745, a number is assigned which needs to be affixed next to the CE-mark for medical devices of risk class higher than I.

The NBs keep the ID number when designated from previous directives, e.g. 93/42/EEC and successfully designated in accordance with this regulation.


2. The Commission shall make the list of the bodies notified under this Regulation, including the identification numbers that have been assigned to them and the conformity assessment activities as defined in this Regulation and the types of devices for which they have been notified, accessible to the public in NANDO. It shall also make this list available on the electronic system referred to in Article 57. The Commission shall ensure that the list is kept up to date.

The commission publishes all NBs successfully designated in accordance to MDR 2017/745 in the database called NANDO. Further, the commission publishes the type of medical devices these NBs can examine.
Please be informed that not every NB successfully listed in the NANDO can examine every risk class of medical device.

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