CE marking is mandatory only for products covered by specific EU harmonised legislation; the manufacturer (or their authorised representative) is legally responsible for conformity, must compile a technical file, sign an EU Declaration of Conformity, and affix the CE mark before placing the product on the EU market. Overview — what CE marking means CE marking is a legal declaration that a product meets all applicable EU directives/regulations (safety, health, environmental,

In 2020, under the commission's initiative ‘A Europe fit for the Digital Age’, an impact assessment of the Machinery Directive identified several gaps. These included the need to address emerging technology risks, clarify scope definitions, enhance provisions for high-risk machinery, promote digital documentation, and resolve divergences in transposition. The assessment emphasized the importance of updating regulations to ensure safety, legal clarity, and technological adapta