FoGia
Involved In Discussions
Hello,
Annex XIV to the MDR states the following:
As anyone an idea why a distinction is made between misuse and off-label use? Are those terms referring to different concepts?
Annex XIV to the MDR states the following:
The PMCF plan shall specify the methods and procedures for proactively collecting and evaluating clinical data with the aim of: [..]
identifying possible systematic misuse or off-label use of the device, with a view to verifying that the intended purpose is correct.
As anyone an idea why a distinction is made between misuse and off-label use? Are those terms referring to different concepts?