All terms
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 CyberLast reviewed July 25, 2026
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 the regulation says
Article 110(3) 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, 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 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. 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.
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Primary references
3 sourcesLink health: 1 verified 2 unchecked· last checked 2026-06-20
EUR-Lex·1MDCG·1European Commission·1
- 1
Regulation (EU) 2024/1860UncheckedEUR-Lexeur-lex.europa.eu
- 2
MDCG 2022-8 Rev.1 Application of Article 110(3)UncheckedMDCGhealth.ec.europa.eu
- 3
European Commission - Medical DevicesVerifiedEuropean Commissionhealth.ec.europa.eu
Inline markers like [1] jump to the matching reference above.