The EU Commission has updated the current state of MDR/IVDR applications with the notified bodies. The results have been documented in a .pdf power point which is split up into 3 sections: About the study and survey, Survey results for medical devices, Survey results for in vitro diagnostic medical devices.
From the results, one can note that the response rate to this survey was a 100 percent, where all 39 notified bodies responded. Out of 39 notified bodies, 29 NBs are designated under the MDR, 9 NBs are designated under both the MDR and IVDR and one NB is designated under the IVDR only.
The MDR survey results concerning a period ending on June 2023 show that there has been a total of 13,177 MDR applications submitted and 3,988 MDR certificates issued. Comparing these figures to the figures that have been reported in March, these latest statistics show an increase of 2,359 in the number of MDR applications and an increase of 1,037 in the number of MDR certificates.
There has also been the addition on the use of Annex XVI and products without a medical intended purpose. The data published shows an increase in the number of applications for such devices when compared to March 2023.
The IVDR survey results concerning a period ending on June 2023 show that 1,155 IVDR applications have been submitted and 500 IVDR certificates have been issued. Comparing these figures to the figures that have been reported in March, these latest statistics show an increase of 205 in the number of IVDR applications and an increase of 169 in the number of IVDR certificates.
What is also worth noting is that although the IVDR deadline for Class D devices is approaching quite fast, there still seems to be quite a low number of applications submitted and certificates granted which stand at 231 and 62 respectively. This is quite alarming and has pressed Team Notified Body to issue a call to action for manufacturers of Class D devices.
The results show a clear trend in which both MDR/IVDR applications and certificates have been increasing with time.
We highly recommend that manufactures start their MDR/IVDR journeys as soon as possible to avoid any delays. Due to the overwhelming demand of notified bodies, we do recommend that you expand your options to include the smaller notified bodies. These could have the capacity and be able to certify you in a timely manner.
What is also worth noting is that although the IVDR deadline for Class D devices is approaching quite fast, there still seems to be quite a low number of applications submitted and certificates granted which stand at 231 and 62 respectively. This is quite alarming and has pressed Team Notified Body to issue a call to action for manufacturers of Class D devices.
The results show a clear trend in which both MDR/IVDR applications and certificates have been increasing with time.
We highly recommend that manufactures start their MDR/IVDR journeys as soon as possible to avoid any delays. Due to the overwhelming demand of notified bodies, we do recommend that you expand your options to include the smaller notified bodies. These could have the capacity and be able to certify you in a timely manner.
The full results from the survey can be downloaded using the following link
