How long can a legacy IVD stay on the market?

Under Article 110 as amended by Regulation (EU) 2022/112 and 2024/1860, Class D legacy devices may remain available into 2027, Class C into 2028, and Class B and sterile Class A into 2029, provided the device undergoes no significant change in design or intended purpose. These are staggered by risk class, with the highest-risk devices facing the earliest deadline.

What kind of change would cause a device to lose its legacy status?

A significant change to the design or intended purpose voids legacy status and typically forces the device into full IVDR conformity assessment immediately, rather than at the extended transition deadline. Manufacturers should assess any labeling, software, or performance-claim update against MDCG guidance on what constitutes a significant change before implementing it.

Is legacy status the same for every notified body relationship?

Legacy status also depends on manufacturers having, by prescribed milestone dates, a written agreement in place with a notified body to progress toward IVDR certification; without that agreement the extended transition timelines for the device's class do not apply. Simply holding a valid IVDD certificate is not sufficient on its own to preserve legacy status through the full extended period.

All terms

RegulatoryRegulated Pathways 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 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 the regulation says

Regulation (EU) 2017/746 (IVDR), adopted on 5 April 2017 and applicable from 26 May 2022, establishes the MedTech legacy-device framework in Article 110. Its transitional provisions were amended by Regulation (EU) 2022/112, adopted on 25 January 2022, and Regulation (EU) 2024/1860, adopted on 13 June 2024. Qualifying IVDD-certified devices may be placed on the market until 31 December 2027. For devices with an IVDD declaration of conformity drawn up before 26 May 2022 that now require notified-body involvement, the deadlines are 31 December 2027 for Class D, 31 December 2028 for Class C, and 31 December 2029 for Class B and sterile Class A. Eligibility requires continued IVDD compliance, no significant changes in design or intended purpose, and no unacceptable risk to health or safety. Manufacturers must establish an IVDR-compliant quality management system by 26 May 2025 and meet the applicable deadlines for notified-body applications and written agreements. IVDR requirements for post-market surveillance, market surveillance, vigilance, and registration of economic operators and devices replace corresponding IVDD requirements. These deadlines concern placing devices on the market or putting them into service, not a blanket cutoff for further supply of units already lawfully placed on the market.

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.

Examples

A Class C HIV diagnostic kit, holding a valid IVDD certificate issued in 2020, can remain on the market until 31 December 2028, provided it meets the IVDR's post-market requirements and does not undergo significant changes.
A self-declared Class B blood glucose monitoring system, placed on the market in 2019 under the IVDD, can continue to be supplied until 31 December 2029 if it complies with IVDR vigilance and market surveillance obligations.
A Class D hepatitis C virus screening assay, certified under the IVDD in 2021, is permitted to be sold until 31 December 2027, as long as its design and intended use remain unchanged and it adheres to IVDR post-market obligations.

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.

Frequently asked questions

No, and this is a very common misunderstanding. Legacy devices under Article 110 must still comply with IVDR post-market surveillance, vigilance reporting, EUDAMED registration, and economic-operator obligations even while continuing to rely on their original IVDD certificate or self-declaration. Legacy status only extends the transition period for full IVDR conformity assessment, not for these ongoing duties.

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.

Regulatory

EUDAMED

European Database on Medical Devices.

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.

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

Where this term appears across MedTech Terms.

Ecosystems (2)

Latest in MedTech

Sources

3 sources

Every citation below opens the original document. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.

Tier 1Binding law and standards· 2Tier 2Regulator guidance and consensus· 1

Link health: 2 verified 1 unchecked· last checked 2026-06-20

EUR-Lex·2FDA·1

Inline markers like [1] jump to the matching reference above.

My progress

All terms0 / 513

Regulatory0 / 101

Saved on this device, and to your account when signed in. View studied terms

Full glossary

Browse all terms A to Z, each with a short definition.

On this term

Category: Regulatory
Sources: 3
Updated: 7/25/2026

Compare with another term

Learn in 60 seconds

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

You may also need

Auto-suggested from Regulatory and shared keywords.

All Regulatory terms

From the Blue Goat network

Related resources and services on this topic.