The statistics as of January 2023 regarding the coverage of the designation codes by MDR/IVDR notified bodies has been published in the attachment.

According to the statistics, more than 80% of codes of the MDR are covered by more than 50% of the notified bodies, while barely 5 codes are covered by less than one-third of the notified bodies, which are:

- MDA 0102 (Active implantable devices delivering drugs or other substances),
- MDA 0104 (Active implantable devices utilizing radiation and other active implantable devices),
- MDA 0103 (Active implantable devices supporting or replacing organ functions),
- MDA 0101 (Active implantable devices for stimulation/inhibition/monitoring), and
- MDS 1002 (Devices manufactured utilizing tissues or cells of human origin, or their derivatives).
 

On the other hand, over 80% of codes of the IVDR are covered by 7 out of 8 notified bodies. Only one code of the IVDR is merely covered by 5 notified bodies, which is IVD 4010 (In vitro diagnostic devices which require knowledge regarding mycology).

For further details, please consult the attachment.

Attachment:
Update - Coverage of Designation Codes by MDR/IVDR Notified Bodies

 

 

Reference:
● Update - Coverage of Designation Codes by MDR/IVDR Notified Bodies