Regulation (EU) 2017/746 (IVDR) sets out the regulatory framework for in vitro diagnostic medical devices placed on the EU market, replacing Directive 98/79/EC (IVDD). It introduces a risk-based classification (Class A, B, C, D) aligned with IMDRF principles and dramatically expands the role of Notified Bodies. It applies from May 26, 2022. Under the new rules most IVDs need notified body involvement, compared with roughly a fifth under the old directive. Performance evaluation now covers scientific validity, analytical performance and clinical performance, plus post-market performance follow-up. Transition periods were extended by Regulations (EU) 2022/112 and 2024/1860.

Why it matters

Under IVDD, roughly 8% of IVDs required Notified Body review. Under IVDR, that figure rises to roughly 80%. Regulation (EU) 2022/112 and Regulation (EU) 2024/1860 staggered transition deadlines through 2027-2029 to prevent supply shortages. Key new obligations include a Performance Evaluation Report (Annex XIII), Post-Market Performance Follow-up (PMPF), Summary of Safety and Performance (SSP) for Class C/D, EU Reference Laboratories for Class D, EUDAMED registration, and Person Responsible for Regulatory Compliance (PRRC) per Article 15. In-house (LDT) tests are permitted under Article 5(5) only with strict justification.

Common pitfalls

•Assuming legacy IVDD CE certificates transfer automatically. They require a Notified Body application and quality system compliance before the applicable Article 110 deadline.
•Under-scoping the Performance Evaluation - IVDR requires scientific validity, analytical performance, and clinical performance as three distinct evidence streams.
•Missing the PMPF plan. It is mandatory even for Class B devices and must be reviewed annually (PSUR for C/D).
•Treating companion diagnostics as generic IVDs. Article 48 requires consultation with EMA or a national medicines authority.

Sources

Regulation (EU) 2017/746 (IVDR) · EUR-Lex
Regulation (EU) 2024/1860 (transition amendment) · EUR-Lex
MDCG Guidance on IVDR · European Commission

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Common comparison patterns

Regulatory pathway choice - 510(k) vs PMA, 510(k) vs De Novo, Abbreviated vs Special 510(k).
Quality systems - QSR vs ISO 13485, QMSR vs QSR.
Software classification - SaMD vs SiMD, Locked vs adaptive AI.
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