The notified body shall have documented procedures in place relating to the assessment of a manufacturer's procedures and documentation relating to clinical evaluation both for initial conformity assessment and on an ongoing basis.
Beidh nósanna imeachta doiciméadaithe i bhfeidhm ag an gcomhlacht dá dtugtar fógra i ndáil le measúnú a dhéanamh ar nósanna imeachta agus doiciméadacht an mhonaróra a bhaineann leis an meastóireacht chliniciúil, don mheasúnú comhréireachta tosaigh agus ar bhonn leanúnach araon.