--- title: "IVDR Transitional Provisions, Definition | MedTech Terms" description: "Extended deadlines under Regulation (EU) 2024/1860 allowing legacy IVDs to remain on the market until 2027 to 2029 based on class." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ivdr-transitional-provisions#term", "name": "IVDR Transitional Provisions", "description": "Article 110 of the IVDR, as amended by Regulation (EU) 2022/112 and Regulation (EU) 2024/1860, extends transitional deadlines for devices lawfully placed on the market under the IVDD. 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[Home](/) 2. [Terms](/terms) 3. [Regulatory](/terms?cat=Regulatory) 4. IVDR Transitional Provisions [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[Global Markets](/ecosystems/global-markets) # IVDR Transitional Provisions Extended deadlines under Regulation (EU) 2024/1860 allowing legacy IVDs to remain on the market until 2027 to 2029 based on class. 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 Regulation (EU) 2024/1860, extends transitional deadlines for devices lawfully placed on the market under the IVDD. Class D legacy devices may remain on the market until 31 December 2027, Class C until 31 December 2028, and Class B and Class A sterile until 31 December 2029, provided conditions in Article 110(3) are met (no significant changes, IVDR-compliant [PMS](/terms/post-market-surveillance)/vigilance/registration, written agreement with a [notified body](/terms/notified-body) by set milestones). What the regulation says Article 110(3) [IVDR](/terms/ivdr) requires that during the transition period devices continue to comply with the IVDD, are subject to no significant changes in design or intended purpose, and satisfy IVDR requirements on [post-market surveillance](/terms/post-market-surveillance), market surveillance, vigilance, registration of economic operators and devices. ## What this means in practice The 2024 amendment also introduced a mandatory manufacturer notification via [EUDAMED](/terms/eudamed) when discontinuing supply of a device that might cause a serious shortage (Article 110a), and made the transitional relief conditional on active progression toward [IVDR](/terms/ivdr) certification, not passive coasting. Common pitfalls - • Treating the extended deadlines as automatic. Manufacturers must have a signed notified-body agreement by 26 September 2025 for Class D, 26 May 2026 for Class C, and 26 May 2027 for Class B/A sterile. - • Missing the Article 110a supply-disruption notice, which is mandatory 6 months in advance. ## 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)[ Regulatory IVDR Risk Classes A–D EU IVDR's risk-based classification: Class A (lowest) to Class D (highest). ](/terms/ivdr-classes) ### 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: 1 verified 2 unchecked · last checked 2026-06-20 EUR-Lex· 1 MDCG· 1 European Commission· 1 1. [1 Regulation (EU) 2024/1860 Unchecked EUR-Lex eur-lex.europa.eu ](https://eur-lex.europa.eu/eli/reg/2024/1860/oj) 2. [2 MDCG 2022-8 Rev.1 Application of Article 110(3) Unchecked MDCG health.ec.europa.eu ](https://health.ec.europa.eu/document/download/2c6c9683-4f45-4e5d-8f5b-2b1c8f5b1e4b_en) 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 7/25/2026 [Compare with another term](/compare?a=ivdr-transitional-provisions) Learn in 60 seconds Card Lesson Quiz Extended deadlines under Regulation (EU) 2024/1860 allowing legacy IVDs to remain on the market until 2027 to 2029 based on class. - · The 2024 amendment also introduced a mandatory manufacturer notification via EUDAMED when discontinuing supply of a device that might cause a serious shortage (Article 110a), and made the transitional relief conditional on active progression toward IVDR certification, not passive coasting. Remember this Watch out: Treating the extended deadlines as automatic. Manufacturers must have a signed notified-body agreement by 26 September 2025 for Class D, 26 May 2026 for Class C, and 26 May 2027 for Class B/A sterile. Related terms - [EU In Vitro Diagnostic Regulation(IVDR) ](/terms/ivdr) - [IVDR Risk Classes A–D ](/terms/ivdr-classes) - [EUDAMED ](/terms/eudamed) You may also need Auto-suggested from Regulatory and shared keywords. - [IVDR Legacy Device ](/terms/ivdr-legacy-device) - [Summary of Safety and Performance (IVDR)(SSP) ](/terms/ivdr-summary-safety-performance) - [AI Act Conformity Assessment (Medical Devices) ](/terms/ai-act-conformity-assessment) - [In-House IVDs (Article 5(5)) ](/terms/ivdr-in-house-devices) - [Notified Body(NB) ](/terms/notified-body) - [CE Mark ](/terms/ce-mark) [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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