The Notified Body Operations Group, NBOG, issued a list of codes for the Notified Body’s scope of designation.
There is one set of codes for the MDR, NBOG F 2017-3, and another set of codes for the IVDR, NBOG F 2017-4.
The MDR codes, for example, fall into two major groups
- Codes Reflecting the Design and Intended Purpose of the Device
- Horizontal Codes
The codes in the first group also include the MDR annexes for conformity assessment. For example, assume a Notified Body wants to be designated for non-active vascular implants delivered sterile under Annex IX. For the first group, the NB would select code MDN 1103 and check the box for Annex IX. For the second group the NB would select MDS 1005 for devices in a sterile condition.
The NB can select as many codes as apply.
Device manufacturers should determine the codes that apply to their devices and verify that the prospective NB has applied for those designations.
The codes lists are available from https://www.nbog.eu/nbog-documents