The authority responsible for notified bodies shall review the assessments by notified bodies of manufacturers' technical documentation, in particular the clinical evaluation documentation as further outlined in Article 45.
Déanfaidh an t-údarás atá freagrach as comhlachtaí dá dtugtar fógra athbreithniú ar mheasúnuithe na gcomhlachtaí dá dtugtar fógra maidir le doiciméadacht theicniúil agus go háirithe ar dhoiciméadacht meastóireachta cliniciúla na monaróirí, mar a leagtar amach níos mine iad in Airteagal 45.