for companion diagnostics, seek the opinion, on the basis of the draft summary of safety and performance and the draft instructions for use, of one of the competent authorities designated by the Member States in accordance with Directive 2001/83/EC or the EMA (either of which to be hereinafter referred to as ‘the medicinal products authority consulted’ depending on which has been consulted under this point) on the suitability of the device in relation to the medicinal product concerned.
I gcás feistí diagnóiseacha coimhdeachta, déanfaidh an comhlacht dá dtugtar fógra, ar bhonn na dréacht-achoimre ar shábháilteacht agus ar fheidhmíocht agus na ndréacht-treoracha úsáide, tuairim a iarraidh ar cheann de na húdaráis inniúla arna n-ainmniú ag na Ballstáit i gcomhréir le Treoir 2001/83/CE nó ó EMA (a ngairtear “údarás inniúil na dtáirgí íocshláinte a ndeachthas i gcomhairle leis” ar cheachtar acu sa Roinn seo feasta) ag brath ar cé acu a ndeachthas i gcomhairle leis maidir lena oiriúnaí atá an fheiste i ndáil leis an táirge íocshláinte lena mbaineann.