ABSTRACT

In global trade, a machine manufacturer must localize its products for different market areas and customers. It must manage a large variety of safety requirements, conformity approvals and product liability issues. The objectives of this study are to review 1) the problems experienced in managing product safety–related compliance in differing market areas and 2) the practices applied to manage compliance. The focus is on the differences in regulatory frameworks for product safety in the European Union (EU) and the United States of America (USA) markets. The study is based on a literature review and interviews with representatives of five European machine manufacturing companies and 16 external organizations that effect on managing compliance. The legal traditions in these two market areas are very different, and the participating EU companies find that the USA market requires special care.