The sampling of files to be reviewed in accordance with paragraph 1 shall be planned and representative of the types and risk of devices certified by the notified body, in particular high-risk devices, and be appropriately justified and documented in a sampling plan, which shall be made available by the authority responsible for notified bodies to the MDCG upon request.
Beartófar sampláil na gcomhad a bhfuil athbhreithniú le déanamh orthu i gcomhréir le mír 1 agus is samplaí a bheidh iontu a fhreagróidh do chineálacha na bhfeistí agus do na rioscaí a bhaineann leo a dheimhnigh an comhlacht dá dtugtar fógra, go háirithe feistí ardriosca, agus tabharfar údar cuí leis an sampláil sin i bplean samplála agus déanfar í a dhoiciméadú sa phlean sin, ar plean í a chuirfidh an t-údarás atá freagrach as comhlachtaí dá dtugtar fógra chuig an GFCL, arna iarraidh sin.