Spremembe odobrenega projekta mora priglašeni organ, ki je izdal certifikat ES o proučitvi projekta, ponovno odobriti, kadarkoli bi lahko spremembe prizadele skladnost z bistvenimi zahtevami direktive ali pogoji, predpisanimi za uporabo pripomočka.
Changes to the approved design must receive further approval from the notified body which issued the EC design-examination certificate wherever the changes could affect conformity with the essential requirements of the Directive or with the conditions prescribed for use of the device.