The chapter provides an overview on the New Legislative Framework (NLF), the history and context that led to the adoption of this legal and “soft-law” framework, and the rationale behind the decisions taken by the legislator. The NLF indeed creates a unique framework for the implementation of legislative projects on the level of the European Union. While other regions rely on a strict type approval process for market access, the European framework ensure a close interaction between policy makers and stakeholders. As instantiated through European Regulation 1025/2012, stakeholders are able to engage into an open and transparent process of developing so-called Harmonized European Norms—or Harmonized Standards—which provide presumption of conformity with a related Legislation once they are listed in the European Union Official Journal. Instead of relying on external services, typically provided by accredited Notified Bodies, self-declaration of conformity is possible which provides a straightforward process to market access that is especially well suited to Small and Midsize Enterprises.