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European IVD Regulations and Risk Based Classification - An Overview for Global Quality Professionals

Our Price: $395.00

Product Code: WB-7051

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About the Product
Contains video file.

The European Commission is in the process of shifting from the current regulatory directive for in-vitro diagnostics to stricter regulations that will apply to all manufactures looking to market their products in Europe. The highly anticipated drafted regulatory proposal for European Diagnostic manufacturers was released in September of 2012 and has been an on-going process with manufacturers looking forward to a new, harmonized set of rules that aim to improve product safety and efficacy through increased performance evaluation requirements. Amid growing public expectations and the advancement of technological innovation, the Commission decided to review and revise the legal framework to improve and strengthen a system which had previously been criticized for being difficult and lacking flexibility. While these regulations have yet to be finalized, the IVD industry anxiously awaits any clarity or guidance in order to best prepare.
  • Outlining specific regulatory provisions and methods for implementation
  • Insight into proposed regulation timeline and key deadlines
  • Unannounced visits under the IVD Directive
  • Changes which will impact the supply chain European economic operators


Sue Spencer
Head IVD

Target Audience
  • Quality Assurance
  • Quality Systems
  • Commercial Quality
  • Regulatory Affairs and Quality Compliance

Target Industry
  • Diagnostic

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