In MEDDEV 2.7/1 (rev 4) the following is discussed under "9.3.2. How to determine the relevance of a data set for the clinical evaluation":
To what extent are the data generated representative of the device under evaluation?
- device under evaluation
- equivalent device
- benchmark device
- other devices and medical alternatives
- data concerning the medical conditions that are managed with the device
What is the exact difference between benchmark device and equivalent device. Is this explained anywhere? I know the rationale for equivalence is described within the text of the MDR, but what about benchmark. Is this just a similar device that you do not prove equivalency to?
To what extent are the data generated representative of the device under evaluation?
- device under evaluation
- equivalent device
- benchmark device
- other devices and medical alternatives
- data concerning the medical conditions that are managed with the device
What is the exact difference between benchmark device and equivalent device. Is this explained anywhere? I know the rationale for equivalence is described within the text of the MDR, but what about benchmark. Is this just a similar device that you do not prove equivalency to?