Legacy device

Legacy devices can stay on the market for a transition period if their conditions are met, but MDR rules on post-market surveillance, vigilance and registration already apply. No significant changes to design or intended purpose are allowed.

Device previously CE marked under Directives 93/42/EEC (MDD) or 90/385/EEC (AIMDD) and placed on the market or put into service after the MDR’s date of application pursuant to Article 120 MDR (per MDCG 2021-25)

MDCG 2024-10, Section 1, Abbreviations and terminology