Medical Application: Regulatory Landscape – Statutory Types

Legal frameworks for regulation of medical devices have traditionally been classed in one of three ways, binding regulation, standards, and soft law. Binding regulations are legally enforceable statutes required for the development and use of technologies in a medical setting. Standards provide for safety and risk control in technology use through the establishment of acceptable design practices and tolerances. Soft law instruments are distinguished from binding regulation by their potential rather than enforceable character. They constitute recommendations for desired policy execution and provide opportunity for legal evolution toward enforceable statutes, a classification that can be expected to aid in the evolution of legal approaches to medical neurotechnology