For each device, manufacturers shall plan, establish, document, implement, maintain and update a post-market surveillance system in a manner that is proportionate to the risk class and appropriate for the type of device.
I dtaca le gach feiste, déanfaidh na monaróirí córas faireachais iarmhargaidh a phleanáil, a bhunú, a dhoiciméadú, a chur chun feidhme, a choinneáil agus a nuashonrú, ar bhealach a bheidh comhréireach le haicme an riosca agus comhoiriúnach do chineál na feiste.