Designation codes for Notified Bodies released by the European NBOG

The Notified Body Operations Group (NBOG) has officially published codes and corresponding types of devices to be used for specifying the scope of the designation of Notified Bodies (NB). This means that NBs can now express their interest in designation under the Medical Devices Regulation (MDR) or In-Vitro Diagnostics Regulation (IVDR).

Draft codes were published in September 2017 and were open for public consultation. The release of the official codes now means manufacturers can investigate which codes are applicable to them. Scopes, which can be defined by referencing to codes, must be listed on the application form with regards to NBs that want to be designated under the MDR or IVDR.

The main difference between the draft and finalised list for IVDs is that a total of 20 previously defined codes have been dropped, leaving a total of 80. There are only minor differences in the list for medical devices and the 71 codes are basically the same as in draft form.

Working documents can be consulted on the NBOG website here.