On 8 July 2024, the Medical Device Coordination Group (MDCG) issued an updated guidance to help manufacturers, notified bodies and health institutions classify in vitro diagnostic (IVD) devices before they are placed on the market under the In Vitro Diagnostic Regulation (IVDR).
The newly revised guidance replaces the former update on 10 February 2023. This is the third revision of the guidance, which was first released in 2020 (RELATED: MDCG releases long-awaited IVD classification guidance, Regulatory Focus 13 November 2020). IVDR went into effect on 26 May 2022, exactly one year after the Medical Device Regulation.
The updated guidance states that conformity assessments are “highly dependent” on the classification in which the IVD is assigned. It explains the IVDR classification rules, gives examples of the classification categories for certain IVDs, and provides a list of seven rules for classifying IVDs.
Under IVDR, diagnostics are divided into four classes, A, B, C and D, from lowest- to highest-risk, based on their intended purpose and their inherent risks. High-risk Class D IVDs are subject to the highest level of scrutiny and may need to be reviewed by an expert panel or tested by an EU reference laboratory (EURL) against common specifications.
For example, Rule 1 states that devices intended to detect the presence of transmissible agents in blood, blood components, cells, tissues or organs would be considered Class D while blood grouping devices would be considered Class C.
Rule 2 states that devices intended to determine fetal-maternal blood group incompatibility would also be considered Class C. Rule 3 covers a range of devices used for testing and classifies some as Class D while others are placed in Class C. Under Rule 4, devices intended for self-testing are classified as class C, except for devices intended to detect pregnancy or for testing fertility, which would be deemed Class B.
The guidance also offers two annexes explaining in more detail the classification of certain devices. The first annex lists examples of how to classify IVDs that are used in combination with others, such as an enzyme-linked immunosorbent assay (ELISA) used in combination with an analyzer. The second annex is a flowchart to determine whether products should be considered in IVD or a companion diagnostic.
Some of the changes from the second revision include the addition of a definition of a kit, which is defined as “a set of components that are packaged together and intended to be used to perform a specific in vitro diagnostic examination, or a part thereof.”
The revision also offers a revised example in Rule 3(a) covering devices for detecting the presence of a sexually transmitted agent, a revision of Rule 4(a) covering devices intended for self-testing, a revised Rule 5(c) covering specimen receptacles, and a revised example of a Class B device under Rule 6.
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