Based on the reports of the reviews and assessments by the authority responsible for notified bodies or joint assessment teams, on input from the market surveillance, vigilance and post-market surveillance activities described in Chapter VII, on the continuous monitoring of technical progress, or on the identification of concerns and emerging issues concerning the safety and performance of devices, the MDCG may recommend that the sampling, carried out under this Article, cover a greater or lesser proportion of the technical documentation and clinical evaluation documentation assessed by a notified body.
Ar bhonn na dtuarascálacha ar na hathbhreithnithe agus ar na measúnuithe rinne an t-údarás atá freagrach as comhlachtaí dá dtugtar fógra nó a rinne na comhfhoirne measúnaithe, ar bhonn ionchur a fuarthas mar thoradh ar ghníomhaíochtaí faireachais mhargaidh, aireachais agus faireachais iar-mhargaidh a ndéantar tuairisc orthu i gCaibidil VII, ar bhonn an fhaireacháin leanúnaigh a dhéantar ar dhul chun cinn teicniúil nó ar bhonn údair imní agus saincheisteanna atá ag teacht chun cinn maidir le sábháilteacht agus feidhmíocht feistí a shainaithint, féadfaidh an GCFL a mholadh go ndéanfar measúnú ar chion níos mó nó níos lú agus den doiciméadacht theicniúil agus den doiciméadacht meastóireachta cliniciúla a ndéanann comhlachtaí dá dtugtar fógra measúnú air, leis an tsampláil a dhéanfar faoin Airteagal seo.