Manufacturers shall report, by means of the electronic system referred to in Article 92, any statistically significant increase in the frequency or severity of incidents that are not serious incidents or that are expected undesirable side-effects that could have a significant impact on the benefit-risk analysis referred to in Sections 1 and 5 of Annex I and which have led or may lead to risks to the health or safety of patients, users or other persons that are unacceptable when weighed against the intended benefits.
Tuairisceoidh monaróirí trí bhíthin an chórais leictreonaigh dá dtagraítear in Airteagal 92 aon mhéadú, a bhfuil tábhacht staitisticiúil ag baint leis, ar mhinicíocht nó ar dhéine teagmhas nach teagmhais thromchúiseacha iad nó ar fho-éifeachtaí neamh-inmhianaithe a bhfuil súil leo iad agus a d'fhéadfadh tionchar suntasach a imirt ar an anailís tairbhe-riosca dá dtagraítear i Roinn 1 agus i Roinn 5 d'Iarscríbhinn I agus a raibh nó a bhféadfadh go mbeadh rioscaí do shláinte nó do shábháilteacht othar, úsáideoirí nó daoine eile mar thoradh orthu agus atá do-ghlactha nuair a mheastar os coinne na sochar atá beartaithe iad.