Updating Your Device In The EU? It Isn't Always Clear When You Need To Tell The Notified Body
In the EU, when do manufacturers need to tell notified bodies about an extension to their product line before placing the updated devices on the market? Is there a definitive answer, or is more clarity needed? Experts weigh in.
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US FDA wants sponsors to complete risk-based assessments and thoroughly consider unintended outcomes of changes they make to already-cleared devices, says a new, highly anticipated draft guidance on 510(k) modifications. This is true whether alterations are made by manufacturers to improve safety or effectiveness, enhance labels, change technology or engineering, or to upgrade materials in a device.
Draft guidance on when to submit a 510(k) for a change to a previously cleared device could increase the number of submissions by two- or three-fold, device makers say. Some call for draft to be withdrawn.
Legislators looking for weak spots in FDA's device pre-market review program have honed in on a perceived loophole that allows firms to change existing 510(k) products without notifying FDA