This message was posted by a user wishing to remain anonymous
Hi Everyone,
We have a 510(k) cleared device submitted for EC certification under MDR as a class IIb device. There is only one literature paper we have got of substantially equivalent device with the same intended use. We don't want to go for clinical investigation route. Our plan is to get the field data from US and use the feedback collected from doctor and submit the same to NB. We assume this would be sufficient and we don't need to go for PMCF studies too.
Can anyone help if this strategy should be fine or we should look into some other evidence also to support for clinical evaluation. We have done the simulation validation studies in house in phantom also.
Thanks for the support.