EU In Vitro Diagnostic Regulation (IVDR) 2017/746

HEADLINE: EU lacked standardized safety measures for in vitro diagnostic devices.

Key Obligations

["CE marking for all IVD devices", "Performance evaluation documentation", "Post-market surveillance"]

Penalty Ranges

Up to €500,000

Affected HS Codes: ["3822", "9027"]

Issuing Authority: European Commission