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.
Definition
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. 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/vigilance/registration, written agreement with a notified body by set milestones).What this means in practice
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.Examples
- A manufacturer of a Class C legacy IVD must ensure a written agreement with a Notified Body is in place by 26 May 2026 to qualify for the extended market period until 31 December 2028.
- A laboratory is still able to use an in vitro diagnostic device for a critical pathogen detection, classified as Class D under IVDR, until December 2027 because the manufacturer is actively progressing towards IVDR certification.
- Following the extension, a company producing a sterile Class A IVD is now preparing for IVDR compliance by December 2029, provided no significant changes are made to the device and post-market surveillance requirements are met.
- •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.
Frequently asked questions
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsRegulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU.
European Database on Medical Devices.
An IVD lawfully placed on the market under IVDD 98/79/EC that continues to be supplied under IVDR transitional provisions.
EU IVDR's risk-based classification: Class A (lowest) to Class D (highest).
More in Regulatory
· Same categoryFDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
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.
Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification.
510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.
Where this term appears across MedTech Terms.
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Sources
3 sourcesEvery 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.
- 1Regulation (EU) 2024/1860Tier 1 UncheckedEUR-Lexeur-lex.europa.eu
- 2MDCG 2022-8 Rev.1 Application of Article 110(3)Tier 2 UncheckedMDCGhealth.ec.europa.eu
- 3European Commission - Medical DevicesTier 2 VerifiedEuropean Commissionhealth.ec.europa.eu
Inline markers like [1] jump to the matching reference above.