The documentation shall be sampled in such a manner as to reflect the risks associated with the intended use of the device, the complexity of the manufacturing technologies, the range and classes of devices produced and any available post-market surveillance information,
Déanfar an doiciméadacht a shampláil sa chaoi is go léireofar na rioscaí a bhaineann leis an úsáid a beartaíodh don fheiste, castacht na dteicneolaíochtaí monaraíochta, raon agus aicmí na bhfeistí a tháirgtear agus aon fhaisnéis atá ar fáil maidir le faireachas iarmhargaidh,