All terms
EU In Vitro Diagnostic Regulation
Regulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026
Definition
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. What the regulation says
The EU IVDR (Regulation (EU) 2017/746) establishes a comprehensive regulatory framework for in vitro diagnostic medical devices within the European Union, emphasizing a life-cycle approach to device safety and performance. It mandates stricter requirements for conformity assessment, clinical evidence, and post-market surveillance compared to its predecessor, Directive 98/79/EC.What this means in practice
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.Examples
- A SARS-CoV-2 PCR assay: Class D (detection of transmissible agent causing life-threatening disease).
- A HbA1c self-test: Class C (management of a chronic condition).
- A pregnancy self-test: Class C (self-testing).
- A clinical chemistry calibrator: Class B.
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.
Frequently asked questions
IVDR uses Rules 1-7 (Annex VIII) based on intended purpose and risk to individual and public health. Class D is the highest risk (transmissible agents, blood grouping) and requires EU Reference Laboratory batch testing plus common specifications.
Cross-references
Related terms
Shared paths + categoryRegulatory
CE Mark
Mandatory European conformity mark for medical devices placed on the EU market.
EU MDR Essentials · adjacentIVDR Essentials · adjacent
Regulatory
EUDAMED
European Database on Medical Devices.
EU MDR EssentialsIVDR Essentials
Regulatory
Notified Body(NB)
EU-designated organization that assesses conformity of medical devices under MDR and IVDR.
EU MDR EssentialsIVDR Essentials
Regulatory
EU Medical Device Regulation(MDR)
Regulation (EU) 2017/745 governing medical devices in the European Union.
EU MDR Essentials · adjacent
Regulatory
Person Responsible for Regulatory Compliance(PRRC)
Named individual required by EU MDR/IVDR Article 15 with regulatory responsibility inside the manufacturer.
Same category
Post-Market
Field Safety Corrective Action(FSCA)
Action taken to reduce a risk of serious deterioration in health associated with a device.
EU MDR EssentialsIVDR Essentials
Latest in MedTech
Primary references
3 sourcesLink health: 2 verified 1 unchecked· last checked 2026-06-20
EUR-Lex·2European Commission·1
- 1Regulation (EU) 2017/746 (IVDR)VerifiedEUR-Lexeur-lex.europa.eu
- 2Regulation (EU) 2024/1860 (transition amendment)UncheckedEUR-Lexeur-lex.europa.eu
- 3MDCG Guidance on IVDRVerifiedEuropean Commissionhealth.ec.europa.eu
Inline markers like [1] jump to the matching reference above.