IVD Regulations and Standards Q&A
Answered February 2nd, 2012 by Expert:
Once the new IVD Directive regulations come into force, IVD manufacturers must meet any new labeling requirements. The CE mark shown on an IVD product reflects the regulations at the time the product was placed on the market, as reflected in an IVD manufacturer’s declaration of conformity. Once an IVD manufacturer applies the new IVD Directive regulations, it must meet any new labeling requirements and apply appropriate conformity routes such that the declaration of conformity denotes the regulations applied not specifically to the label.
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