All terms
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 CyberLast reviewed July 25, 2026
Definition
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.What this means in practice
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. 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.
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510(k) Premarket Notification(510(k))
FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
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.
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.
Regulatory
Abbreviated 510(k)
510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.
Cited by
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Ecosystems (2)
Primary references
3 sourcesLink health: 2 verified 1 unchecked· last checked 2026-06-20
EUR-Lex·2FDA·1
- 1
Regulation (EU) 2017/746, Article 110 (consolidated)VerifiedEUR-Lexeur-lex.europa.eu
- 2
Regulation (EU) 2024/1860UncheckedEUR-Lexeur-lex.europa.eu
- 3
FDA - Medical DevicesVerifiedFDAfda.gov
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