The approval of any substantial change to the quality management system or the device-range covered shall take the form of a supplement to the EU quality management system certificate.
Beidh faomhadh aon athraithe shubstaintiúil ar an gcóras bainistithe cáilíochta nó ar raon na bhfeistí a chumhdaítear i bhfoirm forlíonadh le deimhniú córais bainistithe cáilíochta AE.