US industry says EU device directives not ready for recast
Friday 24 October 2008 Stephen Ubl - President and CEO, AdvaMed

The European Commission wants patients to receive safe and effective medical technology. The medical technology industry does too. We believe the EU has an excellent system that not only delivers safe medical devices but does so in a way that can provide patient access faster than alternatives.

For this reason, we believe the current movement to significantly revise, or “recast,” the EU’s medical device directives– including the In Vitro Diagnostic Directive, Active Implantable Medical Device Directive and Medical Device Directive – is not warranted at this time....

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