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Diagnostics Groups Support Risk-Based Regulatory Regime In Europe

This article was originally published in The Gray Sheet

Executive Summary

Respondents to a European Commission survey, including diagnostics makers and clinical labs, support the creation of a new, risk-based classification system for in vitro diagnostic devices in Europe.

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International News In Brief

European diagnostics directive: The European Commission is considering revising European regulations for in vitro diagnostic devices, and launched a public consultation June 29. The European IVD directive has not been substantially amended since it was adopted in 1998, the commission notes. The consultation is targeted to specific IVD issues, including whether adopting a risk-based classification system for diagnostics would improve the current regulatory framework; whether conformity assessments for diagnostics should be changed; whether tests should require more pre-market clinical evidence; and whether "in-house tests," which are made and used within the same health institution and not marketed elsewhere, should remain exempt from government oversight. Input on the IVD revision is due Sept. 15. Europe launched a public consultation on the recast of the Medical Devices Directives in 2008, with plans to address diagnostics separately (1"The Gray Sheet" June 1, 2009). The European Diagnostics Manufacturers Association supports the revision and held a July 2 workshop to discuss "how best to address the future of IVDs." European trade association Eucomed also says it is preparing comments on the consultation

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