Overall, the legal requirements for AI within the EU have far-reaching business implications, affecting market access, compliance costs, data protection, transparency, and liability. Legal instruments in the EU and Member State law In EU law, the primary differentiation is typically between regulations and directives. Regulations are generally and directly applicable in the EU Member States, holding complete legal authority (according to the Treaty on the Functioning of the European Union (TFEU)). In comparison, directives shall be binding, as to the result to be achieved, but shall leave the choice of form and methods to the national authorities. However, opening clauses allow EU Member Sta