Eucomed laments EU decision
This article was originally published in The Gray Sheet
Executive Summary
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)...