Safety reporting in performance studies of in vitro diagnostic medical devices (IVDs) shall be performed in line with the requirements of Article 76(2) of Regulation (EU) 2017/746 – In Vitro Diagnostic Medical Device Regulation (IVDR):
The sponsor shall report without delay to all Member States in which a performance study is being conducted all of the following by means of the electronic system referred to in IVDR Article 69:
a) any serious adverse event that has a causal relationship with the device, the comparator
or the study procedure or where such causal relationship is reasonably possible;
b) any device deficiency that might have led to a serious adverse event if appropriate action had not been taken, intervention had not occurred, or circumstances had been less
fortunate;
c) any new findings in relation to any event referred to in points a) and b)…
