Case 2: Systems assembled from apparatus including some not CE marked



In this case where the system is composed of No CE marked equipment, but the equipment is considered an apparatus in the sense of the EMC Directive and must comply with all its provisions. The system manufacturer assumes responsibility for the compliance of system as a whole with the Directive. In this case the EC declaration of conformity (made by the system manufacturer) as well as the instructions for use must refer to the system as a whole. It must be clear (eg by enclosing a list of all parts) which is /are the combination(s) that form(s) the system placed on the market for distribution and/or for use. The system as a whole needs to bear the CE marking just once on the main part of the system. Those parts of the system which are themselves compliant apparatus may, of course, be distributed and/or used outside the system. The system manufacturer must therefore provide clear instruction for assembly/installation/operation/maintenance in the instructions for use.