Hello Folks,
Is there any article or white paper that explains on appropriate date range for clinical data to justify equivalence under MDR?
Our concern is we have just 5 years of data and we are going to need to turn around in a few short months and do a 10+ years to satisfy MDR.
Can someone suggest articles or white papers that explains this to refute our concern?
Please provide your personal experience on how you justify the time period chosen for literature searches? How do you propose we justify 5 years for MDR? Do you feel this is appropriate? - our device is a class IIa and has been on the market for a long time, its well understood, etc.
Any suggestion/advise/information is helpful. Thanks!
Is there any article or white paper that explains on appropriate date range for clinical data to justify equivalence under MDR?
Our concern is we have just 5 years of data and we are going to need to turn around in a few short months and do a 10+ years to satisfy MDR.
Can someone suggest articles or white papers that explains this to refute our concern?
Please provide your personal experience on how you justify the time period chosen for literature searches? How do you propose we justify 5 years for MDR? Do you feel this is appropriate? - our device is a class IIa and has been on the market for a long time, its well understood, etc.
Any suggestion/advise/information is helpful. Thanks!