Hi Experts,
We are a small manufacturer based in Australia. A surgeon who is an inventor of a surgical instrument (class IIa) would like to use a custom made device manufactured for him for clinical publication.
Can someone please advise whether the custom made device can be used in clinical trials (surgeon to use custom device at his own practice) for publishing in scientific journals etc. Where do ethics committees come into play here or do they at all in this case? We know some surgeons publish new methods all the time under the declaration of Helsinki, without a separate committee (like NHMRC) assessment.
If the custom made device is cleared to be used by TGA on actual patients, why would a separate ethics committee process be needed to gather data in this case? The medical procedures are being done regardless during a surgeon’s practice.
Aim is to generate clinical data for registering this device with the TGA (ARTG entry) under conformity assessment and prepare CER using both literature from the comparator device and subject device.
Any advise will be greatly appreciated.
Thank you in advance.
We are a small manufacturer based in Australia. A surgeon who is an inventor of a surgical instrument (class IIa) would like to use a custom made device manufactured for him for clinical publication.
Can someone please advise whether the custom made device can be used in clinical trials (surgeon to use custom device at his own practice) for publishing in scientific journals etc. Where do ethics committees come into play here or do they at all in this case? We know some surgeons publish new methods all the time under the declaration of Helsinki, without a separate committee (like NHMRC) assessment.
If the custom made device is cleared to be used by TGA on actual patients, why would a separate ethics committee process be needed to gather data in this case? The medical procedures are being done regardless during a surgeon’s practice.
Aim is to generate clinical data for registering this device with the TGA (ARTG entry) under conformity assessment and prepare CER using both literature from the comparator device and subject device.
Any advise will be greatly appreciated.
Thank you in advance.