Lukas previously posted in the CE Marking forum page:"I am currently consulting on a Drug Eluting Stent project, which has uncovered some uncertainty concerning the CE Mark process for devices. The point of contention is whether or not individual CE Mark approvals are given out each time a device is required to be used in a unique indication (similar to FDA approvals for distinctive indications). To use drug eluting stents as an example, would an additional CE Mark be required so that the device can be used for additional indications (ie. AMI's or in Bifurcations, etc). Any help or guidance would be greatly appreciated."
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