Medical device makers prepare for new European Union edict
Walter Wingo, Standards Editor -- Design News, July 15, 2001
Impending European regulations on medical testing have medical device makers around the world hopping. The European Union is expected to implement its In Vitro Diagnostics (IVD) Directive by December 2003. It will require calibration of medical devices for measuring specific substances in IVD samples, such as cholesterol or glucose, to be traceable to a national standard. Manufacturers will have to comply with the regulations in order to do business in EU member countries. Stakeholders worldwide recently gathered in Gaithersburg, MD, to discuss how to meet the EU directive. The U.S. National Institute of Standards and Technology, meanwhile, is developing a database of reference materials that the IV industry can use. The database will serve as a benchmark for developing individual diagnostic tests for IV samples. E-mail william.koch@nist.gov.
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