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Surprise Inspections, And More, Coming Soon To The EU

It will be years before the device and diagnostic regulations proposed last month by the European Commission take effect, but policymakers are pressing forward to implement select reforms, including surprise facility inspections, on an interim basis by early next year.

The comprehensive device regulatory reforms recently proposed in Europe are still years away from implementation, but policymakers under pressure to take action sooner are moving forward with select reforms as early as January.

Among the shorter-term steps likely to impact manufacturers most directly is the anticipated start of completely unannounced, surprise inspections of company facilities to be conducted by notified bodies, the third-party...

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