Preparing for the New EC IVD Directive Requirements: What Manufacturers Should Know

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This webcast originally aired as a live webinar co-sponsored by AACC and the AACC Industry Division on May 7, 2013. In 2016, the regulatory landscape for in vitro diagnostics (IVDs) will change significantly in the European Union (EU) as a result of a proposal under consideration by the European Commission (EC) that would establish a new regulatory framework for IVDs. The new framework is expected to significantly impact IVD manufacturers who sell products in the EU because a much larger percentage of diagnostic devices will have to be reviewed by notified bodies. Details of the new framework are currently under discussion. During this webcast, Sue Spencer of the British Standards Institute discusses the details of the proposal, as well as how it will potentially affect manufacturers going forward.