"Medical Device Regulation in the European Union"

Horton, Linda R. (1995) "Medical Device Regulation in the European Union". In: UNSPECIFIED, Charleston, South Carolina. (Unpublished)

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Abstract

The challenge to a government in establishing a system of controls over medical devices is to protect patients but without unduly impeding innovation or driving up product costs. Medical devices are, essentially, health care products other than pharmaceuticals.* Medical devices comprise a diverse array of products ranging from simple items like bandages and bedpans to complex products like pacemakers and other implants. Accordingly, the level of control needed to protect patients can range from minimal, for low-risk products, to a more protective level, for those high risk products that need testing and third-party review before entering general use.

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