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.
Le gach feiste, déanfaidh na monaróirí córas faireachais iarmhargaidh a phleanáil, a bhunú, a dhoiciméadú, a chur chun feidhme, a chothabháil agus a nuashonrú ar bhealach atá comhréireach leis an aicme riosca agus atá iomchuí maidir leis an gcineál feiste.