Article originally published in the In Vitro Diagnostics: The Complete Regulatory Guide (Chapter (8) with permission from FDLI), 2010

I. Introduction

This chapter discusses the European Union (EU) regulation of in vitro diagnostic (IVD) medical devices, covering both pre- and postmarket regulatory requirements. In order to understand these rules and the manner in which they operate, both at the EU level and at the national level, it is first necessary to provide an introduction to general principles of EU law and the manner in which the European legislators have sought to facilitate the free movement of a wide variety of products within the EU using so-called “New Approach” directives. This is followed by a discussion of the premarket regulation of IVD medical devices and then a discussion of postmarket regulation.

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