The notified body shall provide a full justification where it has not followed the advice of the expert panel in its conformity assessment report and the Commission shall without prejudice to Article 109 make both the scientific opinion of the expert panel and the written justification provided by the notified body publicly available via Eudamed.
Cuirfidh an comhlacht dá dtugtar fógra bonn cirt iomlán a fáil i gcás nár chloígh sé leis an gcomhairle ón bpainéal saineolaithe ina thuarascáil ar mheasúnú comhréireachta agus cuirfidh an Coimisiún an tuairim eolaíoch ón bpainéal saineolaithe agus an bonn cirt i scríbhinn araon ar fáil go poiblí via Eudamed agus gan dochar d'Airteagal 109.