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Practical impact of unannounced audits for combination product makers in the EU

This article was originally published in SRA

Executive Summary

While there is much speculation as to how the new EU regulatory structure for high-risk devices, including device/drug combinations, will pan out, and how soon the new Medical Device Regulation will take effect, there is a more urgent matter for companies to attend: the tighter regulatory environment that will result from the new European Commission documents on the designation and oversight of notified bodies, and on audits by notified bodies1,2.

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