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Medical device makers prepare for new European Union edict.(In Vitro Diagnostics (IVD)...

By Wingo, Walter
Publication: Global Design News
Date: Friday, June 1 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

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