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).

Why it matters

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.

Sources

Regulation (EU) 2024/1860 · EUR-Lex
MDCG 2022-8 Rev.1 Application of Article 110(3) · MDCG
European Commission - Medical Devices · European Commission

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