The reporting of serious adverse events or device deficiencies during clinical investigations and the reporting of serious incidents occurring after a device has been placed on the market should be clearly distinguished to avoid double reporting.
Ba cheart dealú soiléir a bheith idir tuairisciú tarluithe díobhálacha tromchúiseacha nó easpaí ar fheistí le linn imscrúduithe cliniciúla agus tuairisciú teagmhas tromchúiseach a tharlaíonn tar éis d'fheiste a bheith curtha ar an margadh chun atuairisciú a sheachaint.