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The European Conformity (CE) marking grants early market introduction to innovative high risk medical devices based on safety and device performance only, without any requirement to demonstrate clinical efficacy or effectiveness. Hence healthcare providers, patients and payers are informed neither about the added clinical value compared to an existing medical device nor about the risks incurred by using such innovations. In addition there is a lack of coherence and uniformity of approach in the assessment of high risk medical devices. These gaps may put the health and safety of patients in danger. The European Commission, in concert with Competent Authorities, industry, Notified Bodies, and other stakeholders, is working on a 'recast' of the directives regulating medical devices. This article identifies and discusses the critical points of the pre-market clinical evaluation of innovative high-risk medical devices in the European legal framework and compares it with the USA. [ABSTRACT FROM AUTHOR]