Pre-market Assessment: Authorization to Market
The purpose of pre-marketing control is to ensure that the product's design, functionality, performance, and safety are sufficiently predictable and that the predicted standard of each of these aspects is acceptable. There are explicit requirements for many product types that are covered by vertical regulation, and although there are no explicit requirements for products that are subject to the horizontal GPS provisions, the impact of the GPS requirements and of product liability law makes the voluntary adoption of appropriate measures advisable if not essential. The issues that arise in this chapter are first, to find out who has what obligations to generate or collect information; secondly, to identify the information that should be collected; and thirdly, to find out who needs to take responsibility for the accuracy of the information.
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