A recent survey was conducted by Team-NB to determine how notified bodies were approaching the application process for designation under the new EU IVDR 2017/746. The survey report was closed on January 11th, 2019 and reveals that a total of 35 notified bodies responded, twenty of those were members of Team NB and fifteen were not (non-members NB).
The results from the survey were put in comparison with the current twenty- two notified bodies designated under the currently applicable European IVD Directive 98/79/EC.
There are two major points to keep in mind when analyzing the differences between Team-NB notified bodies members and non-members notified bodies and where they stand with respect to the IVDR designation process ( in or out ).
- Within the 20 Team-NB notified bodies members, 8 are currently undergoing the designation process while a number of 9 notified bodies will not apply and 3 intend to apply later on;
- Among the 15 non-members notified bodies, 4 are currently in the designation process, 6 will not apply and 2 have not made their decision yet;
If we only take into consideration notified bodies that are applying to the IVDR (regardless of their current status being notified under the IVDD), this translates into only 40% of Team NB members, seeking designation under the EU IVDR 2017/746, while 45% are choosing not to apply. Leaving the remainder 15% to those who wish to apply at a later time.
For the 15 non-members, only 20% are in the process of seeking designation, while a whopping 67% are choosing not to extend to the IVDR, and 15% are planning to apply at a later time.
Now, if we take into account the number of notified bodies designated under the IVDD, then most notified bodies (team members and non- members) are applying to be designated under the IVDR.
The survey results and analysis show that within the notified bodies’ members’ pool that submitted their applications:
- 4 members have already had their Joint Assessment audit (JA) and, are currently in the process of addressing the observations of their audit;
- 4 members have officially submitted their application for the designation and;
- 1 intends to submit but at a later time.
The results and analysis for the non- members is equally interesting - It shows indeed that for those who submitted their application:
- 1 has gotten his application checked by its Competent Authority (CA);
- 2 have submitted their applications, and
- 1 will submit its application but at a later date.
In regards to the codes covered by the NB’ applications, all of the codes reflecting the design and intended used as well as the horizontal codes, are covered.
If we analyze those codes in the perspective of the specific treatment area they belong to, then the results from the survey show that within the NB member’s pool:
- 81% or more plan to apply for all codes of devices that “are controls without a quantitative or qualitative assigned value” and provided “in a sterile condition”
- 69% or more intend to apply for all codes for IVD devices that will be used for “markers of cancer, non-malignant tumors”, and “human genetic testing”;
- 63% or more have or will be looking at all codes and devices intended to be used to “determine markers of infections, immune status, non-infectious pathologies, physiological markers, disorders, and therapeutic measure” and “for non-infectious pathologies, physiological markers, disorders / impairments (except human genetic testing), and therapeutic measures
- And finally, 56% or more intend to apply for all codes of devices intended to be used for blood grouping and tissue typing.
Most Notified Bodies regardless of the group they belong to, have applied for a broader application scope under the EU IVDR 2017/746 than under the IVD Directive.
The survey concludes that there are currently about the same number of notified bodies currently designated under the IVDD, to serve, medical device manufacturers under the IVDR, we can therefore expect, that given the scope, of devices, covered by the IVDR there will be less notified bodies to answer the demands.