Diagnostics Groups Support Risk-Based Regulatory Regime In Europe

Article preview from "The Gray Sheet"- February 28, 2011

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.

Diagnostics Groups Support Risk-Based Regulatory Regime In Europe

Article preview from "The Gray Sheet"- February 28, 2011

The European Commission floated possible revisions to in vitro diagnostic devices regulations last June and sought input through a public consultation. (See " European diagnostics directive " – "The Gray Sheet" July 19, 2010.)

The European IVD directive has not been substantially changed since it was first enacted in 1998.

A summary report of the responses was published Feb. 23, bringing European regulators a step closer to establishing a revised framework for IVDs marketed in Europe.

The commission received 183 responses to its survey, from clinical labs, medical associations, hospitals and health care professionals, manufacturers, individual countries' competent authorities and notified bodies.

 

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