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The QMN Weekly Bulletin
June 8, 2012 | Vol. 4 No. 23
Devicemakers Call Out CMC Over New EU Labeling Requirement
Implementing a new labeling requirement by the EU’s Central Management Committee (CMC) on Medical Devices will raise devicemakers’ costs without any benefit to patient safety, industry association Eucomed says.
“Decision No. 3” requires medical devicemakers to put their complete street address on both the device label and instructions for use. The new requirement means companies can no longer list the addresses of post office boxes, sales offices or customer centers. The requirement is set to take effect Sept. 1.
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