Requirements Assessment
A Requirements Assessment (often called "Regulatory Mapping") is the foundational first step in the CE marking journey. Before conducting a Risk Assessment or designing a testing protocol, a manufacturer must definitively identify which legal rules apply to their specific equipment. For North American exporters, this is critical because a single machine often falls under multiple competing or overlapping jurisdictions.
For example, a motorized packaging machine might simultaneously require compliance with the Machinery Regulation (for moving parts), the Low Voltage Directive (LVD) (for power units), and the EMC Directive (for electronics). If the machine has Wi-Fi, it shifts to the Radio Equipment Directive (RED). Failing to identify these during the Requirements Assessment can lead to significant gaps in the Technical File.
This assessment also identifies which Harmonized Standards should be applied to presume conformity. The output is a "Applicable Requirements List" which serves as the blueprint for the entire conformity project, ensuring no legal obligation is overlooked before Placing on the Market.
