IVDR

Official standard

Full Name

In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746

Region

European Union

Codes

Crosswalk Edges

Authority

European Parliament and Council

Data Provenance

Manual TranscriptionLicense: Public Domain (EUR-Lex)Source

Hierarchy Explorer

Hierarchy ExplorerClick to expand - equivalences appear inline

classificationClassification

clinicalClinical Evidence and Performance

conformityConformity Assessment

obligationsEconomic Operator Obligations

pmsPost-Market Surveillance

scopeScope and Definitions