IVDR (EU In Vitro Diagnostic Regulation 2017/746)
Europe's rules for diagnostic tests, which since 2022 require most cancer tests to be certified by an independent body before they carry a CE mark, with deadlines for older tests running to 2029.
Overview
Regulation (EU) 2017/746 replaced the 1998 IVD Directive and applied from 26 May 2022, moving from self-declaration to risk-based classification (A to D) in which about 80% of tests, including companion diagnostics (class C) and many cancer assays, need notified-body assessment. Companion diagnostics also require consultation with the medicines regulator. Because notified-body capacity lagged, Regulation (EU) 2024/1860 extended transition for legacy devices to 31 December 2027 (class D), 31 December 2028 (class C) and 31 December 2029 (class B and A sterile), provided manufacturers had applied to a notified body by set dates, and required manufacturers to warn of supply interruptions. In-house tests made by hospital laboratories have a separate, lighter regime under Article 5(5). The UK operates its own UKCA regime with continued recognition of CE marks. For patients the CE mark under IVDR is closer to FDA approval than the old CE mark was, but still does not require proof of clinical utility.