Classification in European Union — in vitro diagnostics

The IVDR is not a variant of the MDR — it asks different questions for a different reason. An MDR device is assessed on the harm it can do to the person using it. An in vitro diagnostic can endanger people who never touch it: a test that fails to detect a transmissible agent in donated blood puts a recipient, and potentially a population, at risk. So IVDR classification weighs individual risk and public health risk together, a dimension the MDR has no equivalent of. Nothing in the MDR questionnaire — invasiveness, duration of contact, whether the device is active — bears on the answer.

Classes A to D, where D is the highest and is reserved for tests on transmissible agents and life-threatening conditions with a high propagation risk. There is no correspondence with MDR classes I to III. The other change worth knowing: under the previous directive most in vitro diagnostics were self-declared, whereas under the IVDR only Class A is — and Class A is narrow. The proportion requiring a Notified Body inverted.

The MDR covers medical devices; the IVDR covers in vitro diagnostics — devices that examine specimens taken from the body. They were adopted the same day and share much structure, but they use different classification rules and different class labels: I, IIa, IIb, III against A, B, C, D.

Not yet. The engine implements Annex VIII of the MDR only. The IVDR needs an engine of its own because its rules turn on what a test detects and the consequence of a wrong result, not on invasiveness or duration of contact.