The manufacturer shall specify how to manage the incidents referred to in the first subparagraph and the methodology used for determining any statistically significant increase in the frequency or severity of such incidents, as well as the observation period, in the post-market surveillance plan referred to in Article 84.
Sonróidh an monaróir, sa phlean faireachais iarmhargaidh dá dtagraítear in Airteagal 84, an bealach a mbainisteofar na teagmhais dá dtagraítear sa chéad fhomhír agus an mhodheolaíocht a úsáidtear chun aon mhéadú atá suntasach ó thaobh staidrimh de, ar mhinicíocht nó ar dhéine teagmhas den sórt sin a chinneadh, agus saineoidh sé ann freisin an tréimhse bhreathnóireachta.