EUROPEAN DIRECTIVE ON MEDICAL TESTING DEMANDS TRACEABILITY.

The European Union's In Vitro Diagnostics (IVD) Directive, which is expected to be implemented by December 2003, will require the calibration of medical devices for measuring specific substances in IVD samples, such as cholesterol or glucose, to be traceable to a national standard. U.S. manufacturers, which produce more than 60 % of the devices sold in Europe, will need to comply with the directive in order to do business in the EU member countries.

A recent workshop at NIST marked the first time that stakeholders worldwide gathered to discuss the issues raised by the impending regulation and make recommendations for dealing with it. Traceability to a national standard will help assure that an individual test achieves the same results for the IVD sample, no matter which manufacturer's device is used. Today, many diagnostic tests have to be redone because of inconsistent results.

As a follow-up to the "Workshop on Measurement Traceability for Clinical Laboratory Testing and In Vitro Diagnostic Test Systems," NIST is developing a database of currently available reference materials and methods, which will be accessible on the NIST World Wide Web site within the next few months. This information will help the IVD industry by serving as a benchmark for developing individual diagnostic tests.