--- title: "IVDR, EU In Vitro Diagnostic Regulation | MedTech Terms" description: "Regulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU. Plain-English Regulatory definition for MedTech teams, with examples and relat" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ivdr#term", "name": "EU In Vitro Diagnostic Regulation", "alternateName": "IVDR", "description": "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). 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It must not be industrially manufactured, must meet Annex I general safety and performance requirements, and requires justification that no CE-marked equivalent exists on the market." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Regulatory](/terms?cat=Regulatory) 6. / 7. EU In Vitro Diagnostic Regulation [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[Global Markets](/ecosystems/global-markets)IVDR # 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 Cyber](/authors/christian-espinosa) Last 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](/terms/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](/terms/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](/terms/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](/terms/pmpf) ( [PMPF](/terms/ivdr-pmpf)), Summary of Safety and Performance ( [SSP](/terms/ivdr-summary-safety-performance)) for Class C/D, EU Reference Laboratories for Class D, [EUDAMED](/terms/eudamed) registration, and [Person Responsible for Regulatory Compliance](/terms/prrc) (PRRC) per Article 15. In-house ( [LDT](/terms/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 How is IVDR classification different from MDR? 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](/terms/common-specifications). When did IVDR apply? Is a Notified Body required for every IVD? What is an in-house test under Article 5(5)? ## Cross-references ### Uses Concepts or artefacts this term builds on. - [ IVDR Risk Classes A–D ](/terms/ivdr-classes) - [ Common Specifications(CS) ](/terms/common-specifications) ### Contains Sub-elements or required artefacts of this term. - [ IVDR Risk Classes A–D ](/terms/ivdr-classes) - [ Common Specifications(CS) ](/terms/common-specifications) ### Often confused with Distinct concept frequently mistaken for this one. - [ EU Medical Device Regulation(MDR) MDR covers devices; IVDR covers in-vitro diagnostics. ](/terms/mdr) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory CE Mark Mandatory European conformity mark for medical devices placed on the EU market. ](/terms/ce-mark)[ Regulatory EUDAMED European Database on Medical Devices. ](/terms/eudamed)[ Regulatory Notified Body(NB) EU-designated organization that assesses conformity of medical devices under MDR and IVDR. ](/terms/notified-body)[ Regulatory EU Medical Device Regulation(MDR) Regulation (EU) 2017/745 governing medical devices in the European Union. ](/terms/mdr) ### EU MDR Essentials · From this learning path [ Post-Market Field Safety Corrective Action(FSCA) Action taken to reduce a risk of serious deterioration in health associated with a device. ](/terms/fsca?from=eu-mdr-essentials)[ Post-Market Medical Device Vigilance Reporting and management of serious incidents and field safety corrective actions. ](/terms/vigilance?from=eu-mdr-essentials)[ Regulatory Unique Device Identification(UDI) System for adequate identification of medical devices through distribution and use. ](/terms/udi?from=eu-mdr-essentials)[ Post-Market Periodic Safety Update Report(PSUR) Periodic EU MDR/IVDR report summarizing post-market surveillance findings. ](/terms/psur?from=eu-mdr-essentials) ### IVDR Essentials · From this learning path [ Regulatory IVDR Risk Classes A–D EU IVDR's risk-based classification: Class A (lowest) to Class D (highest). Adjacent lesson ](/terms/ivdr-classes?from=ivdr-essentials)[ Regulatory General Safety and Performance Requirements(GSPRs) Annex I requirements under EU MDR/IVDR that every device must demonstrate it meets. ](/terms/gspr?from=ivdr-essentials)[ Clinical & Trials Clinical Evaluation Plan(CEP) 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). ](/terms/clinical-evaluation-plan?from=ivdr-essentials)[ Market Segments Companion Diagnostic(CDx) IVD that identifies patients who will benefit from a specific drug. ](/terms/companion-diagnostic?from=ivdr-essentials) Cited by Where this term appears across MedTech Terms. Learning paths (2) - [EU MDR Essentials](/paths/eu-mdr-essentials)Lesson 2 of 9 - [IVDR Essentials](/paths/ivdr-essentials)Lesson 1 of 13 Ecosystems (2) - [Regulated Pathways](/ecosystems/regulated-pathways) - [Global Markets](/ecosystems/global-markets) Comparisons (1) - [EU MDR vs EU IVDR](/compare/mdr-vs-ivdr)vs EU Medical Device Regulation ## Primary references 3 sources Link health: 2 verified 1 unchecked · last checked 2026-06-20 EUR-Lex· 2 European Commission· 1 1. [1 Regulation (EU) 2017/746 (IVDR) Verified EUR-Lex · eur-lex.europa.eu ](https://eur-lex.europa.eu/eli/reg/2017/746/oj) 2. [2 Regulation (EU) 2024/1860 (transition amendment) Unchecked EUR-Lex · eur-lex.europa.eu ](https://eur-lex.europa.eu/eli/reg/2024/1860/oj) 3. [3 MDCG Guidance on IVDR Verified European Commission · health.ec.europa.eu ](https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Navigating an FDA or EU MDR submission? Blue Goat Cyber supports the cybersecurity content of premarket submissions, from threat models to the 524B narrative. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Regulatory Acronym IVDR Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=ivdr) Learn in 60 seconds Card Lesson Quiz Regulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU. - · 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. Remember this Watch out: Assuming legacy IVDD CE certificates transfer automatically. They require a Notified Body application and quality system compliance before the applicable Article 110 deadline. Related terms - [EU Medical Device Regulation(MDR) ](/terms/mdr) - [Notified Body(NB) ](/terms/notified-body) - [EUDAMED ](/terms/eudamed) - [CE Mark ](/terms/ce-mark) - [Person Responsible for Regulatory Compliance(PRRC) ](/terms/prrc) You may also need Auto-suggested from Regulatory and shared keywords. - [IVDR Risk Classes A–D ](/terms/ivdr-classes) - [IVDR Transitional Provisions ](/terms/ivdr-transitional-provisions) - [IVDR Legacy Device ](/terms/ivdr-legacy-device) - [EU Reference Laboratory (EURL)(EURL) ](/terms/ivdr-eu-reference-laboratory) - [Companion Diagnostic (IVDR)(CDx) ](/terms/ivdr-companion-diagnostic) - [General Safety and Performance Requirements (IVDR)(GSPR) ](/terms/ivdr-gspr) [All Regulatory terms](/terms?cat=Regulatory) From the Blue Goat network Related resources and services on this topic. - [ MedTech Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.com) - [ MedTech Cybersecurity Standards Authoritative reference for the standards and guidances behind medical device cybersecurity. ](https://medtechcyberstandards.com) - [ MedTech Truths Common misconceptions about medical device development - debunked. ](https://mdcmisconceptions.com) - [ MedTech Launchpad MedTech funding rounds, accelerators, and launch resources. ](https://medtechlaunchguide.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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