Need help understanding how language in your intended use can change an IVD classification, per recommendation of a NB

Mike W

Starting to get Involved
Hi Everyone,

my background is more US-based Lab-develop tests in clin affairs and recently got my foot in the door into global reg. Here is the situation im confused about and would appreciate any insight.

1. Manufacturer is looking to create a new in-vitro diagnostic device for QUANT detection of an antigen for CE mark. And also considering it as "Class C"
2. I was under the impression that all infectious disease assays are given "CLASS D", but apparently per the NB, we can classify our new test as "Class C" if the language in the intended use says that the test is for "AID IN MANAGEMENT for those with already confirmed diagnosis". As oppose to Class D devices, in which the language is clear that the intended use is for diagnosis.

Im so lost here. To me, a doctor is going to use the test how they see fit, whether its for the initial diagnosis, or if you want to monitor disease progression, treatment response -AKA "aid in management" (similar to CD4 levels in HIV patient). the language is not going to change the capabilities of the test, at least thats my understanding.

3. Why can't the manufacturer simply say that this new test is for the "quantitative detection of said analyte" and leave it at that?Is there language in the new IVDR that states that stating an intended use like that is no longer allowed??

4. Since the intended use is NOT for diagnosis, then does that mean that "DIAGNOSTIC SENSITIVITY/CLINICAL SENSITIVITY would NOT be a product requirement??

5. How would you evaluate clinical performance? A method comparison study? but what if the other assays that are currently CE marked have different language in their intended use (they pre-date IVDR requirements and say they are for diagnosis of said analyte)

Thank you everyone, appreciate any input.


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It would be interesting to see how the NB got there. Do you think it's consistent with MDCG 2020-16 rev.2?
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