where the competent authority for medical devices of the Member State in which the manufacturer of the device covered by the certificate has its registered place of business has confirmed that there is no safety issue associated with the devices in question; and
tá sé dearbhaithe ag an údarás inniúil maidir le feistí leighis sa Bhallstát ina bhfuil a áit ghnó chláraithe ag monaróir na feiste a chumhdaítear leis an deimhniú nach ngabhann aon tsaincheist sábháilteachta leis na feistí atá i gceist; agus