In vitro diagnostic medical devices in EUDAMED
Browse medical devices in the “In vitro diagnostic medical devices” EMDN category registered in EUDAMED. Each result links to its manufacturer, certificates, and identifiers.
1001 medical devices in EUDAMED
About the In vitro diagnostic medical devices category
In vitro diagnostic medical devices are tested on samples taken from the body rather than used on the patient directly — reagents, assays, analysers, calibrators and controls, and self-test kits. Crucially, IVDs are regulated under a separate regulation, IVDR 2017/746, with their own A-to-D risk classes rather than the MDR’s I-to-III scheme. This is one of the fastest-evolving regulatory areas, as products that previously self-certified now require Notified-Body assessment under the IVDR.
Common questions
Are in vitro diagnostics regulated under the MDR?
No. IVDs fall under the In Vitro Diagnostic Regulation (IVDR) 2017/746, which is separate from the MDR; they use risk classes A, B, C and D instead of the MDR’s Class I to III, with class D being the highest risk.
What kinds of products count as IVDs?
IVDs include laboratory reagents and assays, diagnostic analysers, calibrators and control materials, blood-grouping and infection-screening tests, and self-tests — any device intended to examine specimens such as blood, tissue or other samples taken from the body.