Lost in the Post-Market Surveillance Clinical Follow-up

L

LoliF

#1
Hello !

I am a little bit lost in the "clinical follow-up" as part of the PMS.
Are we require to made declaration to a competent authority if we would like to follow the use "on the field" of our CE-mark device ?
In which case are we required to declare ?

For instance, 2 cases:

1) The follow-up of a CE-mark range of MD.
Practionners are asked to complete a form with some information such as patient information (i.e. age, sex, medical history...), the selected device among a same range according to the patient, their feedback and the one of the patient.

2) The follow-up of 2 CE-marked MD, quite similar (i.e. one is the evolution of the other).
Both have the same manufacturer (they are in the same range), both have the CE-mark, both have the same intended use, both may be used jointly usually.
Practionners are asked to use both devices with the same patient and then they complete a form with some information such as patient information (i.e. age, sex, medical history...), their feedback & the one of the patient and their preference (the former device or the evolution).

I am wondering if in these 2 cases we are still in a classic PMS (Post-Market Surveillance) clinical follow-up or if we are required to declare something to a competent authority.

Thanks a lot for your help
 
Elsmar Forum Sponsor
S

SteveK

#2
Hi and welcome to the Cove,

If you are just using some type of questionnaire to gather data e.g. on the usibility etc of the device, I do not see that you have to declare anything assuming it is not invasive. I does not seem to consitute a 'clinical trial'. If you indicate what the device does it might help more wrt feedback on the questions.

There is a thread on PMS which maybe of help.

http://elsmar.com/Forums/showthread.php?t=30317&highlight=post+market+surveillance

Steve
 
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