Analytical methods are often developed at one site and transferred to other sites for routine use. Increasingly, the method development is made by manufacturers of instruments and reagents. Regulatory agencies have ruled that the responsibility for the performance of IVDs in the laboratories mainly should lie with...

The Directive is a complex and detailed document and in the following the author focuses on some of the items that are particularly important for the user to be aware of.  Most of the rules will apply to the manufacturers and the public and the users will take advantage of the rulings if they become aware of their...