Conformity assessment without current or listed harmonised European standards (hEN)

Manufacturers wishing to sell products on the European Single Market must assess and document their conformity with the applicable EU regulations. Harmonised European Standards (hEN) serve as a proven means of verification and provide a presumption of conformity, provided they are applied in full. However, if no current hENs are available, alternative verification methods must be used. This guide explains practical steps for technical conformity assessment, including the identification of regulatory requirements, the use of alternative technical specifications and the possible involvement of notified bodies. In the long term, active monitoring of the standardisation landscape is recommended in order to remain legally compliant and competitive.