Glossary · Regulation
IVDR
EU In Vitro Diagnostic Medical Devices Regulation (2017/746)
The IVDR is the EU regulation for in vitro diagnostic devices, applicable since May 2022, covering tests performed on samples taken from the body and the software that interprets them.
Software that calculates a diagnostic result from lab data can fall under the IVDR rather than the MDR, with classes A to D.
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Definitions written by Anpheros from the official sources linked on each page. General information about standards and regulation, not legal or medical advice. All terms →