EU Industry Still Wary Of Borderline Devices After Positive Parliament Vote
This article was originally published in The Gray Sheet
Executive Summary
The European Parliament's device-supporting plenary session vote Oct. 23 in Strasbourg largely rejects the suggested primacy of the revised Directive 2001/83/EC on the Community Code relating to Medicinal Products for Human Use over the Medical Devices Directive
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Regulatory costs for combination products could "multiply drastically," Eucomed warns in reaction to a Dec. 17 vote by the European Parliament failing to "turn down an amendment suggesting the primacy of the revised Directive 2001/83/EC." Parliament's failure to vote on the issue will introduce "legal uncertainty and confusion" for devices that also contain a drug component, Eucomed says. The Parliament previously has voted to define drugs as products that have pharmacological action "as their primary mode of action" (1"The Gray Sheet" Oct. 28, 2002, p. 18)...
Eucomed laments EU decision
Regulatory costs for combination products could "multiply drastically," Eucomed warns in reaction to a Dec. 17 vote by the European Parliament failing to "turn down an amendment suggesting the primacy of the revised Directive 2001/83/EC." Parliament's failure to vote on the issue will introduce "legal uncertainty and confusion" for devices that also contain a drug component, Eucomed says. The Parliament previously has voted to define drugs as products that have pharmacological action "as their primary mode of action" (1"The Gray Sheet" Oct. 28, 2002, p. 18)...
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