WORKSHOP SEEKS MORE OPEN EUROPEAN MARKET FOR LAB, DIAGNOSTIC TESTS.

NIST hosted a workshop in November 2000, to address a potential non-tariff trade barrier for U.S. medical diagnostic devices in the European Union. The workshop, "Measurement Traceability for Clinical Laboratory Testing and In Vitro Diagnostic Test Systems," was geared for members of the medical diagnostics industry, professional organizations, government, and national and international standards developing organizations.

A new EU directive on in vitro diagnostics will require that calibration of all new medical diagnostic devices be traceable to "standards of a higher order" by 2003. Existing diagnostic products, without the EU stamp of approval, can remain on the market only until 2005. Although NIST produces many reference materials for medical tests, the United States currently does not have a formalized system for tracing the accuracy of all tests performed with in vitro diagnostic devices and systems. U.S. manufacturers, who produce over 60 % of the devices sold in Europe, potentially could have their products challenged on the basis of this directive.

The 2 day workshop was held at NIST, Gaithersburg, MD. It is co-sponsored by NIST, the American Association for Clinical Chemistry, the Centers for Disease Control and Prevention, the Health Industry Manufacturers Association and the National Committee for Clinical Laboratory Standards.