MDR devices

MDCG guidance sorts devices into three groups: old devices, legacy devices and MDR devices. The group decides which MDR requirements apply and how, for example for registration in EUDAMED and for vigilance reporting.

MDR devices are those that are placed on the market or put into service as being in conformity with the MDR other than ‘legacy devices’.

MDCG 2021-25 Rev.1, Section 2.2, Terminology used in this guidance