The introduction of a rule based classification for IVDs is one of the more significant changes between the new European In Vitro Diagnostics Regulation (EU IVDR) and the current In Vitro Diagnostics Directive (IVDD).

That said, even under the current IVDD the manufacturer has to categorise his device; Annex II list A, Annex II list B, a device for self-testing or other device, with this categorisation determining the options for conformity assessment. So the idea is not completely new. However, for a convenient visualisation of the four new classes and to understand the rationale behind the classification, readers should look at the GHTF Study Group 1 document “Principles of in vitro diagnostic (IVD) medical devices classification” GHTF/SG1/NO45:2008

The obligation to assign a classification to all IVDs is contained in Article 47 of the new EU IVDR, with the rules to be followed in determining the classification contained in the new Annex VIII. The new Article 47 does however clarify, that where a Manufacture and Notified Body cannot agree on a classification, the Competent Authority of Manufacturer makes the final determination. While this is the current practice under the IVDD it was not specifically stated in the IVDD.

Comparing the EU IVDR Annex VIII to the current IVDD:
– Rules 1 and 2 in the new EU IVDR are primarily concerned with IVDs which are used to test the safety of blood and blood derivatives, cells, tissues and organs for transfusion or transplantation. IVDs in this group, Group D, represent the highest risk as the failure of such a test could lead to a wide spread threat to public health or an immediate life threatening condition for an individual. The new rules 1 and 2 broadly correspond to List A in Annex II of the current IVDD.
– Rules 3 and 4 in the new EU IVDR are concerned with IVDs where an erroneous result which could present a moderate public health risk or a high risk to an individual. IVDs in this group, Group C, are often the only means of diagnosis or are used by lay persons to make life determining decisions; e.g. an insulin dose calculation for someone suffering with diabetes. The new rules 3 and 4 broadly correspond to List B in Annex II of the current IVDD.
– Rule 5 in the new EU IVDR deals with IVDs posing the least risk of all. The rationale being that IVDs in this group, Group A, pose a low individual risk and minimal public health risk. That certainly seems to be the case for accessories and products for general laboratory use, but instruments? The proper classification of instruments has long been a topic of debate. But for the forseeability future instruments will remain in Class A, at least in Europe. Class A broadly corresponds to the IVDD’s “other” devices; i.e. not Annex II, and not for self-testing.
– Rules 6 and 7 are concerned with the remainder of the tests which are not covered by rules 1 to 5. But those remaining probably represent the majority of IVDs on the EU market in numerical terms; test run in clinical laboratories, in health institutions for so called near-patient testing, other tests intended for self-testing by lay persons. IVDs in this group, Group B, are considered to represent a moderate individual risk.

The establishment of Group B in the new EU IVDR is the really big difference compared to the IVDD. By some estimates, 80% of the IVDs currently on the EU market will be classified as class B under the new EU IVD. Currently, under the IVDD, these tests are considered to be low risk and are exempt from conformity assessment by a Notified Body. Under the EU IVDR Notified Body assessment will be required before such tests can be marketed. That represents a massive change for the IVD industry and is probably the main reason why the IVD sector has been given an extra two years for transition compared to the rest of the medical device industry.

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