IVDR (Regulation 2017/746)

The In Vitro Diagnostic Regulation is the EU law for in vitro diagnostic devices, parallel to the MDR for other medical devices.

IVD manufacturers still need a quality system, technical documentation, performance evaluation and post-market follow-up. The classification and the notified-body involvement differ from the MDR. This entry does not restate the regulation.

HAVGATE's audit engine is built around ISO 13485, MDSAP, EU MDR and QMSR. It does not ship a separate IVDR clause library. Say that plainly if an IVD company asks.