Information on risk classification for IVDs under new IVDR regulations

According to the IVDR's, Annex VIII now defines four classes In lieu of the previous lists A and B. The classes are based on the Global Harmonization Task Force classification scheme and are determined using seven rules, which are explained in more detail in Annex VIII of the IVDR:

• Class D: highly critical data, e.g. for transfusion medicine or determination of life-threatening or infectious diseases
• Class C: critical data, e.g. human genetic testing, determining levels of medicinal products, detecting infectious or inherited diseases in the embryo or fetus. Most self-tests (performed by the patients) fall within class C.
• Class B: less critical parameters such as glucose or leukocytes. Class B is also the default class for all parameters which do not fall within the scope of any of the stated rules.
• Class A: uncritical devices such as washing solutions or general culture media are classified as class A.

IVDR even divides in-vitro diagnostic products into further categories:

• devices for near-patient testing
• devices for self-testing
• companion diagnostic devices that are essential for the safe and effective use of a corresponding medicinal product. An example would be a genetic test verifying whether a cytostatic is effective.

The new classification scheme means that IVD devices not fitting into any of the classes will be considered Class B, falling under NB supervision. This is an important distinction because they would have been self-declared previously, under the IVDD.