Devicemakers Call Out CMC Over New EU Labeling Requirement

June 8, 2012

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.

International compliance is no longer simply a matter of following the same old rules.  Enforcement activities and practices are changing. Countries are beginning to share data about manufacturing companies, increase the number of inspections and crack down on issues such as counterfeiting and improper marketing. You learn the new rules of the game, or cede the playing field to competitors.

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