Classification of IVDs
Classification according to the IVDR is based on the intended purpose of the IVD in accordance with a classification system based on risk rules (see IVDR Annex VIII). This system comprises seven rules and leads to four different risk classes (A-D). In principle, the seven classification rules consider the personal and public risk associated with a device. A device is assigned to the higher risk class if it has several intended purposes. The classification of a device determines the conformity assessment route (further details).
The picture below presents an overview on the IVDR risk classes and the underlying classification rules and risk assessment routes:
In addition to the known classification rules, there also exist additional sub-classifications of IVDs, e.g.:
- Point-of-care tests (POCT)
- Products for self-use (by patients / laypersons)
- Companion Diagnostics (CDx)
- Lab-developed tests (LDTs)
