Unannounced notified body visits for combination products: tips on how to prepare
This article was originally published in Clinica
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 regulations will take effect. However, there is a more urgent matter for manufacturers of these products to attend to: the tighter regulatory environment that will result from the new European Commission rules – adopted at the end of September – on the designation and oversight of notified bodies, and on audits conducted by notified bodies.
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