EU In Vitro Diagnostic Regulation
Regulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU.
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. 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.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.
- •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
Cross-references
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsMandatory European conformity mark for medical devices placed on the EU market.
European Database on Medical Devices.
EU-designated organization that assesses conformity of medical devices under MDR and IVDR.
Regulation (EU) 2017/745 governing medical devices in the European Union.
EU MDR Essentials
· From this learning pathAction taken to reduce a risk of serious deterioration in health associated with a device.
Reporting and management of serious incidents and field safety corrective actions.
System for adequate identification of medical devices through distribution and use.
Periodic EU MDR/IVDR report summarizing post-market surveillance findings.
IVDR Essentials
· From this learning pathEU IVDR's risk-based classification: Class A (lowest) to Class D (highest).
Annex I requirements under EU MDR/IVDR that every device must demonstrate it meets.
EU MDR document that defines the scope, methods, and acceptance criteria for the clinical evaluation that will be reported in the Clinical Evaluation Report (CER).
IVD that identifies patients who will benefit from a specific drug.
Where this term appears across MedTech Terms.
- EU MDR EssentialsLesson 2 of 9
- IVDR EssentialsLesson 1 of 13
- EU MDR vs EU IVDRvs EU Medical Device Regulation
Sources
3 sourcesEvery citation below opens the original document. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
- 1Regulation (EU) 2017/746 (IVDR)Tier 1 VerifiedEUR-Lexeur-lex.europa.eu
- 2Regulation (EU) 2024/1860 (transition amendment)Tier 1 UncheckedEUR-Lexeur-lex.europa.eu
- 3MDCG Guidance on IVDRTier 2 VerifiedEuropean Commissionhealth.ec.europa.eu
Inline markers like [1] jump to the matching reference above.