 Sue Spencer BSI Healthcare Global Head of IVD Visit Website |
Sue Spencer has twenty-six years of experience in the IVD industry, and has held various positions in R&D, Manufacturing, and Quality Assurance. She joined BSI in 2009 as Head of IVD, where she has developed a full scope Notified Body that can provide a responsive IVD service to clients world-wide.
Previously, Sue worked for a UK Notified Body as a Technical and Operations Manager covering both the Medical Device and IVD Directives during the introduction of both the Medical Device and IVD Directives, and as a consultant before joining a large global diagnostic manufacturer as Manager for International Quality Systems and Risk Management for the Division. She is an experienced instructor and regularly delivers interactive training courses with accelerated learning objectives. Want more information? Download IVD Materials at http://www.bsiamerica.com/IVDdoc |
IVD Regulations and Standards Q&A
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How will the revised IVD Directive regulations affect the CE mark that may already be on the label of a given IVD product?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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