Clinical Evaluation Benchmark vs. Equivalent

mf389

Registered
#1
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?
 
Elsmar Forum Sponsor

indubioush

Quite Involved in Discussions
#2
A benchmark device is a device that another company makes that has the same intended purpose as yours and in which you strive to match in terms of clinical performance and safety profile.
 
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