Glossary Term
In Vitro Diagnostic Regulation
Abbreviation: IVDR
Regulatory DefinitionsEN
Definition
EU Regulation 2017/746 governing in vitro diagnostics, which replaced the IVDD with stricter evidence, post-market surveillance, and reclassification rules. Products legacy-listed under the IVDD may still carry transitional timelines, so registration status should be verified per product and per market.