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Is it possible to start a PIT (physician initiated study) for a medical device that does not have CE mark yet as an investigational deevice? with the full responsibility of the investigator?
or is the device, still the responsability of the manufacturer?
Can you point out to the appropriate MDD/MDD guidelines for this?
Thank you!!
or is the device, still the responsability of the manufacturer?
Can you point out to the appropriate MDD/MDD guidelines for this?
Thank you!!