Regulatory/EU milestones/Legacy IVDR Class D transition ends

IVDRDec 31, 2027 · Upcoming

Legacy IVDR Class D transition ends

About this milestone

Regulations (EU) 2022/112 and 2024/1860 extended IVDR transition for legacy in vitro diagnostics that had a certificate or declaration under Directive 98/79/EC before 26 May 2022, subject to QMS and notified-body application deadlines. Class D (highest risk) legacy devices have an extended transition ending 31 December 2027.

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This page summarises an official EU timeline for general information. It is not legal advice; check the official text for your obligations.