Altenstetter C
Graduate School and University Center of the City University of New York, NY 10036, USA.
Health Policy. 1996 Jan;35(1):33-52. doi: 10.1016/0168-8510(95)00771-7.
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.
欧盟法规、当前各国的做法和规则、实施监管调整的机构能力以及过去卫生和监管政策及传统的遗留问题之间存在着复杂的关系。然而，关于医疗器械政策、医疗器械行业以及医疗器械安全与使用保障的实证信息却很少。根据对二手文献的回顾和正在进行的实地调研，有证据表明，当前以国家为中心的传统与自我监管传统的结合，在决定欧盟规则的实施和最终结果方面，将与新规则本身同样重要。欧盟指令重新设计规则，但它们不一定会导致机构变革、创造人力、技能和机构能力，也不一定会在短期内改变治理和行政做法。欧盟指令和国家监管调整都无法决定“人机/技能-经验”界面，该界面是由当地医疗传统以及当地公众对这些传统的接受程度所塑造和影响的。
