IVDR: Why 80% of Diagnostics Suddenly Needed a Notified Body

Regulation (EU) 2017/746, the In Vitro Diagnostic Regulation, replaced the IVD Directive and applied from May 2022. It is the sister regulation to MDR, and for diagnostics the change was more disruptive than MDR was for devices.

The inversion

Under the old directive, classification was list-based. Two annex lists named higher-risk products; anything not on them was self-certified. In practice roughly 80% of IVDs were self-certified.

IVDR replaced that with risk-based classification in four classes, A to D, driven by the risk to the individual and to public health. The result inverted: roughly 80% now require a notified body.

That is the whole story of IVDR in one number. A manufacturer that had never engaged a notified body suddenly needed one, at the same moment every other IVD manufacturer did, against a limited number of bodies designated for IVDR.

The classes

• Class A: low individual and public health risk. General laboratory products, instruments, specimen receptacles. Self-certified, unless sterile.
• Class B: most self-testing devices, and anything not fitting another rule.
• Class C: higher individual risk. Companion diagnostics, cancer staging, infectious disease detection where a wrong result is serious, genetic testing.
• Class D: highest. Life-threatening transmissible agents in blood or organ screening, where a wrong result carries public health consequence. Class D adds EU reference laboratory involvement and batch verification.

Performance evidence

IVDR asks for a performance evaluation built on three pillars, and all three are required:

• Scientific validity. The analyte is associated with the clinical condition.
• Analytical performance. The device measures the analyte correctly: sensitivity, specificity, trueness, precision, limits of detection, interference.
• Clinical performance. The results correlate with the clinical condition or physiological state in the target population.

The performance evaluation report is to IVDR what the CER is to MDR, and it is updated through post-market performance follow-up.

Laboratory-developed tests

IVDR carries a health institution exemption: tests made and used within the same health institution are exempt from most requirements, subject to conditions, including that no equivalent CE-marked device is available on the market.

That last condition is the binding one. A laboratory relying on the exemption has to keep checking whether a commercial equivalent has appeared, because its arrival ends the exemption for that test.