European IVD Directive "effective date" set for July 1, 1998.
This article was originally published in The Gray Sheet
EUROPEAN UNION IVD DIRECTIVE EFFECTIVE DATE PROPOSED FOR JULY 1, 1998, according to a copy of the directive recently released by the EU's Commission of the European Communities. The effective date marks the beginning of a transition period during which manufacturers of in vitro diagnostic products can either comply with the directive's provisions in order to obtain the union's CE mark of conformity or continue to follow member states' current laws covering IVDs.
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