Regulating healthcare technologies and medical supplies in the European economic area

A complex relationship exists among EU regulations, current national practices and rules, institutional capacities to implement regulatory adjustments and the legacy of past health and regulatory policy and traditions. However, there is little empirical information on medical devices policy, the medical devices industry, and the assurance of medical device safety and usage. Drawing on a review of the secondary literature and on-going field work, the evidence suggests that the current mix of state-centric and self-regulatory traditions will be as important in determining the implementation and final outcomes of EU-rules as the new rules themselves. EU directives redesign rules, but they do not necessarily lead to institutional change, create manpower, skills and institutional capacities, or alter governance and administrative practices in the short term. Neither EU directives nor national regulatory adjustments determine the 'man-machine/skills-experience' interface which is shaped and influenced by local medical traditions and the acceptance of these traditions by local publics.