--- title: "IVDR Legacy Device, Definition | MedTech Terms" description: "An IVD lawfully placed on the market under IVDD 98/79/EC that continues to be supplied under IVDR transitional provisions." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ivdr-legacy-device#term", "name": "IVDR Legacy Device", "description": "Article 110 of the IVDR, as amended by Regulation (EU) 2022/112 and 2024/1860, allows devices with valid IVDD certificates or self-declared devices already on the market before 26 May 2022 to remain available for defined periods (into 2027 for Class D, 2028 for Class C, 2029 for Class B and sterile Class A), subject to no significant change in design or intended purpose and compliance with IVDR post-market and vigilance requirements.", "url": "https://medtechterms.com/terms/ivdr-legacy-device", "termCode": "ivdr-legacy-device", "inDefinedTermSet": { "@type": "DefinedTermSet", "name": "MedTech Terms", "url": "https://medtechterms.com/terms" } }, { "@type": "Article", "@id": "https://medtechterms.com/terms/ivdr-legacy-device#article", "headline": "IVDR Legacy Device", "description": "An IVD lawfully placed on the market under IVDD 98/79/EC that continues to be supplied under IVDR transitional provisions.", "url": "https://medtechterms.com/terms/ivdr-legacy-device", "mainEntityOfPage": { "@type": "WebPage", "@id": "https://medtechterms.com/terms/ivdr-legacy-device" }, "about": { "@id": "https://medtechterms.com/terms/ivdr-legacy-device#term" }, "articleSection": "Regulatory", "inLanguage": "en", "keywords": "IVDR Legacy Device, Regulatory, medical device, MedTech", "author": { "@type": "Person", "name": "Christian Espinosa", "jobTitle": "Founder, Blue Goat Cyber", "url": "https://bluegoatcyber.com" }, "publisher": { "@type": "Organization", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "isPartOf": { "@type": "WebSite", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "datePublished": "2026-07-25", "dateModified": "2026-07-25", "citation": [ { "@type": "CreativeWork", "name": "Regulation (EU) 2017/746, Article 110 (consolidated)", "url": "https://eur-lex.europa.eu/eli/reg/2017/746/oj", "publisher": { "@type": "Organization", "name": "EUR-Lex" } }, { "@type": "CreativeWork", "name": "Regulation (EU) 2024/1860", "url": "https://eur-lex.europa.eu/eli/reg/2024/1860/oj", "publisher": { "@type": "Organization", "name": "EUR-Lex" } }, { "@type": "CreativeWork", "name": "FDA - Medical Devices", "url": "https://www.fda.gov/medical-devices", "publisher": { "@type": "Organization", "name": "FDA" } } ], "mentions": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ivdr#term", "name": "EU In Vitro Diagnostic Regulation", "alternateName": "IVDR", "url": "https://medtechterms.com/terms/ivdr" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/eudamed#term", "name": "EUDAMED", "url": "https://medtechterms.com/terms/eudamed" } ] }, { "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": 1, "name": "Home", "item": "https://medtechterms.com/" }, { "@type": "ListItem", "position": 2, "name": "Terms", "item": "https://medtechterms.com/terms" }, { "@type": "ListItem", "position": 3, "name": "Regulatory", "item": "https://medtechterms.com/terms?cat=Regulatory" }, { "@type": "ListItem", "position": 4, "name": "IVDR Legacy Device", "item": "https://medtechterms.com/terms/ivdr-legacy-device" } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. [Terms](/terms) 3. [Regulatory](/terms?cat=Regulatory) 4. IVDR Legacy Device [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[Global Markets](/ecosystems/global-markets) # IVDR Legacy Device An IVD lawfully placed on the market under IVDD 98/79/EC that continues to be supplied under IVDR transitional provisions. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed July 25, 2026 ## Definition Article 110 of the [IVDR](/terms/ivdr), as amended by Regulation (EU) 2022/112 and 2024/1860, allows devices with valid IVDD certificates or self-declared devices already on the market before 26 May 2022 to remain available for defined periods (into 2027 for Class D, 2028 for Class C, 2029 for Class B and sterile Class A), subject to no significant change in design or intended purpose and compliance with IVDR post-market and vigilance requirements. ## What this means in practice Legacy status is a bridge, not a permanent state. Even legacy devices must comply with [IVDR](/terms/ivdr) [post-market surveillance](/terms/post-market-surveillance), vigilance, registration in [EUDAMED](/terms/eudamed), and economic-operator obligations from the transition dates. Common pitfalls - • Treating legacy status as an exemption from post-market obligations. It is not. - • Making a design change during the transition that voids legacy status. ## 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 EUDAMED European Database on Medical Devices. ](/terms/eudamed) ### 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)[ Regulatory 510(k) Summary vs 510(k) Statement Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request. ](/terms/510k-summary-vs-statement)[ Regulatory 513(g) Request for Information(513(g)) Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification. ](/terms/513g)[ Regulatory Abbreviated 510(k) 510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards. ](/terms/abbreviated-510k) Cited by Where this term appears across MedTech Terms. Ecosystems (2) - [Regulated Pathways](/ecosystems/regulated-pathways) - [Global Markets](/ecosystems/global-markets) ## Primary references 3 sources Link health: 2 verified 1 unchecked · last checked 2026-06-20 EUR-Lex· 2 FDA· 1 1. [1 Regulation (EU) 2017/746, Article 110 (consolidated) Verified EUR-Lex eur-lex.europa.eu ](https://eur-lex.europa.eu/eli/reg/2017/746/oj) 2. [2 Regulation (EU) 2024/1860 Unchecked EUR-Lex eur-lex.europa.eu ](https://eur-lex.europa.eu/eli/reg/2024/1860/oj) 3. [3 FDA - Medical Devices Verified FDA fda.gov ](https://www.fda.gov/medical-devices) 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 7/25/2026 [Compare with another term](/compare?a=ivdr-legacy-device) Learn in 60 seconds Card Lesson Quiz An IVD lawfully placed on the market under IVDD 98/79/EC that continues to be supplied under IVDR transitional provisions. - · Legacy status is a bridge, not a permanent state. - · Even legacy devices must comply with IVDR post-market surveillance, vigilance, registration in EUDAMED, and economic-operator obligations from the transition dates. Remember this Watch out: Treating legacy status as an exemption from post-market obligations. It is not. Related terms - [EU In Vitro Diagnostic Regulation(IVDR) ](/terms/ivdr) - [EUDAMED ](/terms/eudamed) You may also need Auto-suggested from Regulatory and shared keywords. - [IVDR Transitional Provisions ](/terms/ivdr-transitional-provisions) - [CE Mark ](/terms/ce-mark) - [Person Responsible for Regulatory Compliance(PRRC) ](/terms/prrc) - [Post-Market Surveillance Plan (IVDR) ](/terms/ivdr-pms-plan) - [AI Act Post-Market Monitoring ](/terms/ai-act-post-market-monitoring) - [General Safety and Performance Requirements(GSPRs) ](/terms/gspr) [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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