--- title: "IVDR Risk Classes A–D, Definition | MedTech Terms" description: "EU IVDR's risk-based classification: Class A (lowest) to Class D (highest). Plain-English Regulatory definition for MedTech teams, with examples and related ter" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ivdr-classes#term", "name": "IVDR Risk Classes A–D", "description": "Under EU IVDR (2017/746), IVDs are classified A, B, C, or D based on intended purpose and risk to individuals and public health. 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For Class D devices, compliance with relevant CS is generally mandatory, and they also apply to specific analytes, regardless of the device class, as specified in relevant implementing acts." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Regulatory](/terms?cat=Regulatory) 6. / 7. IVDR Risk Classes A–D [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[Quality System](/ecosystems/quality-system)[Global Markets](/ecosystems/global-markets) # IVDR Risk Classes A–D EU IVDR's risk-based classification: Class A (lowest) to Class D (highest). Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition Under EU [IVDR](/terms/ivdr) (2017/746), IVDs are classified A, B, C, or D based on intended purpose and risk to individuals and public health. Class B and above generally require [Notified Body](/terms/notified-body) involvement. What the regulation says The [EU In Vitro Diagnostic Regulation](/terms/ivdr) (IVDR, 2017/746) outlines a risk-based classification system for in vitro diagnostic medical devices, categorizing them into four classes: A, B, C, and D. This classification is determined by the device's intended purpose and the risks it poses to individual and public health, as detailed in IVDR Annex VIII. Regulators expect manufacturers to correctly classify their devices as this dictates the conformity assessment route and the level of [Notified Body](/terms/notified-body) involvement required. ## What this means in practice [IVDR](/terms/ivdr) shifted ~80% of IVDs into [Notified Body](/terms/notified-body) oversight (vs. ~20% under IVDD), creating sustained capacity strain. [Common Specifications](/terms/common-specifications) apply for Class D devices and certain analytes. ## Examples - A manufacturer of a new immunoassay for detecting a highly transmissible and dangerous virus would classify it as Class D, necessitating stringent conformity assessment, including Notified Body involvement and potentially expert panel review. - A company developing a self-test for monitoring blood glucose levels for diabetic patients would likely classify it as Class B due to the moderate individual risk, requiring Notified Body assessment for conformity. - A producer of a general-purpose laboratory instrument, such as a centrifuge, used in IVD procedures but not an IVD itself, would likely have its associated consumables classified as Class A. Common pitfalls - • Misclassifying an IVD can lead to significant regulatory hurdles, including delays in market access or non-compliance penalties. - • Underestimating the evidence required for higher risk classes, particularly for Class C and D devices, is a common pitfall. - • Failing to consider all aspects of the intended purpose when determining the risk class can result in an incorrect classification. - • Neglecting to update the risk classification if the intended purpose or technology of the IVD changes can lead to non-conformity. - • Assuming that a device's classification under the IVDD automatically translates to the same class under the IVDR is incorrect due to the stricter IVDR rules. ## Frequently asked questions How does IVDR classification differ from IVDD? The [IVDR](/terms/ivdr) introduced a significantly stricter classification system compared to the IVDD, reclassifying approximately 80% of IVDs into higher risk categories that require [Notified Body](/terms/notified-body) oversight, whereas under the IVDD only about 20% did. What are examples of devices in each class? What is the role of Common Specifications? ## Cross-references ### Used by Things that build on this term. - [ EU In Vitro Diagnostic Regulation(IVDR) ](/terms/ivdr) ### Part of A larger framework or document this term belongs to. - [ EU In Vitro Diagnostic Regulation(IVDR) ](/terms/ivdr) ### See also Closely related context worth reading. - [ Companion Diagnostic(CDx) ](/terms/companion-diagnostic) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory EU In Vitro Diagnostic Regulation(IVDR) Regulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU. ](/terms/ivdr)[ Regulatory Notified Body(NB) EU-designated organization that assesses conformity of medical devices under MDR and IVDR. ](/terms/notified-body)[ Regulatory Common Specifications(CS) Mandatory technical specifications under EU MDR/IVDR where harmonized standards are insufficient. ](/terms/common-specifications) ### IVDR Essentials · From this learning path [ Regulatory CE Mark Mandatory European conformity mark for medical devices placed on the EU market. ](/terms/ce-mark?from=ivdr-essentials)[ Market Segments Companion Diagnostic(CDx) IVD that identifies patients who will benefit from a specific drug. Adjacent lesson ](/terms/companion-diagnostic?from=ivdr-essentials)[ Regulatory EUDAMED European Database on Medical Devices. ](/terms/eudamed?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) ### More in Regulatory · Same category [ Regulatory 510(k) Premarket Notification(510(k)) FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate. ](/terms/510k) Cited by Where this term appears across MedTech Terms. Learning paths (1) - [IVDR Essentials](/paths/ivdr-essentials)Lesson 2 of 13 Ecosystems (3) - [Regulated Pathways](/ecosystems/regulated-pathways) - [Quality System](/ecosystems/quality-system) - [Global Markets](/ecosystems/global-markets) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 EUR-Lex· 1 FDA· 1 European Commission· 1 1. [1 EU IVDR (2017/746) Verified EUR-Lex · eur-lex.europa.eu ](https://eur-lex.europa.eu/eli/reg/2017/746/oj) 2. [2 FDA - Medical Devices Verified FDA · fda.gov ](https://www.fda.gov/medical-devices) 3. [3 European Commission - Medical Devices Verified European Commission · health.ec.europa.eu ](https://health.ec.europa.eu/medical-devices-sector_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 Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=ivdr-classes) Learn in 60 seconds Card Lesson Quiz EU IVDR's risk-based classification: Class A (lowest) to Class D (highest). - · IVDR shifted ~80% of IVDs into Notified Body oversight (vs. - · ~20% under IVDD), creating sustained capacity strain. - · Common Specifications apply for Class D devices and certain analytes. Remember this Watch out: Misclassifying an IVD can lead to significant regulatory hurdles, including delays in market access or non-compliance penalties. Related terms - [EU In Vitro Diagnostic Regulation(IVDR) ](/terms/ivdr) - [Notified Body(NB) ](/terms/notified-body) - [Common Specifications(CS) ](/terms/common-specifications) You may also need Auto-suggested from Regulatory and shared keywords. - [Summary of Safety and Performance (IVDR)(SSP) ](/terms/ivdr-summary-safety-performance) - [IVDR Transitional Provisions ](/terms/ivdr-transitional-provisions) - [ANVISA(ANVISA) ](/terms/anvisa) - [Class III Device ](/terms/class-iii) - [EU Reference Laboratory (EURL)(EURL) ](/terms/ivdr-eu-reference-laboratory) - [In-House IVDs (Article 5(5)) ](/terms/ivdr-in-house-devices) [All Regulatory terms](/terms?cat=Regulatory) From the Blue Goat network Related resources and services on this topic. - [ MedTech Cybersecurity Standards Authoritative reference for the standards and guidances behind medical device cybersecurity. ](https://medtechcyberstandards.com) - [ MedTech Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.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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