m8r-lhgra4
Registered
Hi all, I was wondering given that MEDDEV 2.7/1 rev4 requires equivalent (clinical, technical, biological) device to be used in clinical data and some NB even ask for technical data of the equivalent device. Is literature route still possible? It seems like an overkill for existing mature Class I or IIa device to perform clinical investigations (clinical trials).
clinical investigation(s) or other studies reported in the scientific literature, of a similar device for
which equivalence to the device in question can be demonstrated; or
- published and/or unpublished reports on other clinical experience of either the device in
question or a similar device for which equivalence to the device in question can be
demonstrated.