Glossary · EU in vitro diagnostics: IVDR

Device classification (IVDR)

Also known as: IVDR risk classes, Class A, B, C and D (IVDR), IVDR classification rules

Under the EU In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746, device classification assigns each IVD to one of four risk classes, A (lowest) to D (highest), by applying the seven classification rules of Annex VIII to the device’s intended purpose and inherent risks. The class determines the conformity assessment route and the depth of evidence and post-market obligations.

EU
IVDR

In one sentence

IVDR classification: seven Annex VIII rules sort IVDs into classes A to D by intended purpose and risk, which sets the conformity assessment route.

Example

A manufacturer classifies its HIV blood-screening assay for donated blood as class D, its companion diagnostic for a cancer drug as class C, its pregnancy self-test as class B and its non-sterile specimen tube as class A.

How it applies

Class D: High individual and high public health risk, for example devices that detect transmissible agents in blood, blood components, cells, tissues or organs intended for transfusion or transplantation.
Class C: High individual or moderate public health risk, for example many genetic tests, cancer screening tests and companion diagnostics (Rule 3). Self-tests are class C unless listed as lower risk.
Class B and A: Class B is the default for devices not covered by another rule and includes several self-tests such as pregnancy tests. Class A covers, among others, instruments intended specifically for IVD procedures and specimen receptacles.
Conformity assessment: Non-sterile class A devices are self-declared; sterile class A and classes B, C and D need a notified body. For class D, EU reference laboratories and expert panels can be involved.
Guidance: MDCG 2020-16 explains the rules with examples. If several rules apply, the highest class wins.
Technical documentation: Record the classification rationale with the rule applied, the intended purpose wording it relies on and why other rules do not apply. The rationale is one of the first things a notified body checks.

IVDR vs. MDR classification

The MDR uses classes I, IIa, IIb and III and 22 rules based largely on invasiveness, duration and active function; see Device classification (MDR). The IVDR uses letters, seven rules and bases the class on what the test result is used for and what a wrong result would mean for the patient and public health.