EU quality management system certificates and EU quality assurance certificates for class I devices for which the involvement of a notified body is required pursuant to Article 52(7) shall include a statement that the audit by the notified body of the quality management system was limited to the aspects required under that paragraph.
Áireofar ar dheimhnithe córais bhainistithe cháilíochta AE agus ar dheimhnithe dearbhaithe cáilíochta AE le haghaidh feistí aicme a cheanglaíonn rannpháirtíocht comhlachta dá dtugtar fógra de bhun Airteagal 52(7) ráiteas go raibh an t-iniúchadh a rinne an comhlacht dá dtugtar fógra ar an gcóras bainistithe cáilíochta teoranta do na gnéithe a cheanglaítear faoin mír sin.