Kim Carneiro
Danish Institute of Fundamental Metrology
Building 307, Anker Engelunds Vej 1
DK-2800 Lyngby
Denmark
Tel: +45 4525 5867
Fax: +45 4593 1137
e-mail: kc@dfm.dtu.dk
home-page: http://www.dfm.dtu.dk
Harmonized European legislation is initiated by European Directives, which is subsequently implemented in the member states of the European Union. Products that comply with directives (subject to pattern approval by a notified body) are CE-marked by their producers to indicate that they are safe to use. The In Vitro Diagnostics Directive issued by the European Parliament and the European Council of Ministers on 28. November 1998 is to be implemented no later than December 2003. It states the essential requirements for the proper functioning of in vitro diagnostic medical devices and their accessories. Of particular interest to the instrument manufacturers is that measurements must be traceable to reference standards (and associated procedures) of a higher order. The paper discusses the implications of this requirement