Relevant data and information gathered through post-market surveillance, as well as lessons learned from any implemented preventive and/or corrective actions, should be used to update any relevant part of technical documentation, such as those relating to risk assessment and clinical evaluation, and should also serve the purpose of transparency.
Maidir leis na sonraí ábhartha agus an fhaisnéis ábhartha a bhailítear trí fhaireachas iarmhargaidh, chomh maith leis na ceachtanna a fhoghlaimítear ó aon ghníomaíochtaí coisctheacha agus/nó ceartaitheacha a cuireadh chun feidhme, ba cheart leas a bhaint astu chun aon chuid ábhartha den doiciméadacht theicniúil, amhail iad siúd a bhaineann le measúnú riosca agus meastóireacht chliniciúil, a nuashonrú, agus ba cheart dóibh freisin fónamh don trédhearcacht.