The Regulation (EU) 2017/745 on medical devices, hereafter referred to as the MDR (medical device regulation), provides a possibility to use clinical data related to an equivalent device in the clinical evaluation required for a device under conformity assessment.
Whilst carrying out a clinical investigation is the most direct way to generate clinical data concerning the safety and performance of devices for the purpose of CE marking, clinical data can also be sourced from data of a device for which the equivalence to the device in question can be demonstrated. In such cases, equivalence shall be demonstrated according to the MDR requirements…
