Media Advisory

Media Advisory NIST Workshop on Measurement Traceability for Clinical Laboratory Testing and In Vitro Diagnostic Test Systems to be Held Nov. 2-3. Reporters are invited to cover the upcoming workshop at the National Institute of Standards and Technology that will address a potential non-tariff trade barrier for U.S. medical diagnostic devices in the European Union. A new EU directive on in vitro diagnostics requires that the calibration of all new medical devices be traceable to "standards of a higher order" by 2003. Today, the United States does not have a formalized system for tracing the accuracy of all tests performed with in vitro diagnostic devices. As a result, U.S. manufacturers, who produce more than 60 percent of the devices sold in Europe, could have their products challenged under the new directive. The workshop will take place Nov. 2-3 in the Green Auditorium of the NIST Administration Building, Gaithersburg, Md. The program begins at 9 a.m. Speakers will include scientific experts from the United States and Europe. An agenda is available on the workshop web page at www.cstl.nist.gov/nist839/ivd.html. Sponsors: National Institute of Standards and Technology, National Committee for Clinical Laboratory Standards, Centers for Disease Control and Prevention, Advanced Medical Technology Association, College of American Pathologists and American Association for Clinical Chemistry. Reporters planning to cover the workshop should contact Pamela Houghtaling at (301) 975-5745 or pamela.houghtaling@nist.gov. -30-
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Media Advisory

NIST Workshop on Measurement Traceability for Clinical Laboratory
Testing and In Vitro Diagnostic Test Systems to be Held Nov. 2-3.

Reporters are invited to cover the upcoming workshop at the National Institute of Standards and Technology that will address a potential non-tariff trade barrier for U.S. medical diagnostic devices in the European Union. A new EU directive on in vitro diagnostics requires that the calibration of all new medical devices be traceable to "standards of a higher order" by 2003. Today, the United States does not have a formalized system for tracing the accuracy of all tests performed with in vitro diagnostic devices. As a result, U.S. manufacturers, who produce more than 60 percent of the devices sold in Europe, could have their products challenged under the new directive.

The workshop will take place Nov. 2-3 in the Green Auditorium of the NIST Administration Building, Gaithersburg, Md. The program begins at 9 a.m. Speakers will include scientific experts from the United States and Europe. An agenda is available on the workshop web page at www.cstl.nist.gov/nist839/ivd.html.

Sponsors: National Institute of Standards and Technology, National Committee for Clinical Laboratory Standards, Centers for Disease Control and Prevention, Advanced Medical Technology Association, College of American Pathologists and American Association for Clinical Chemistry.

Reporters planning to cover the workshop should contact Pamela Houghtaling at (301) 975-5745 or pamela.houghtaling@nist.gov.

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FOR IMMEDIATE RELEASE: Oct. 27, 2000

FOR IMMEDIATE RELEASE:
Oct. 27, 2000