The in vitro diagnostic directive. What it doesn't say, but manufacturers need to know

By now, everyone should have a copy of the In Vitro Diagnostic (IVD) Directive. After careful reading, people are realizing that there is much that the Directive does not say and much that is wide open to interpretation--interpretation that could make a big difference to the IVD industry. This article highlights those parts of the Directive that are unclear and therefore will need to be discussed and interpreted.