The relationship of private rules, non-governmental standards and (state) law, a classical subject of the sociology of law, is of particular relevance, also from an international perspective, in medical and healthcare systems. The development of standards within the medical profession, in the form of guidelines, directives and recommendations, is of great importance in this context, reflecting several overlapping and partly conflicting strands of development, e.g. processes of scientification, of internal self-regulation within the profession and of external regulation of medical practice. The increased importance of professional norm generation stands in contrast to a deficit of knowledge regarding their normative qualification and empirical relevance. Acceptance and implementation within the profession and legal reception are at present in an instable state of suspension. The status and effect of relevant rules are problematic while processes of standard setting are to some extent intransparent. It is therefore time for an interdisciplinary socio-legal analysis of the development and validity of this type of “non-law”.