A Device Or Not A Device? 12 New Entries To EU Borderline Manual
Executive Summary
The EU's manual on borderline products, where there is some ambiguity about whether medical device/IVD oversight applies, is set to be updated in line with the new Medical Devices and IVD Regulations. But in advance of that, the EU manual has been updated to provide guidance on 12 additional product types under the still-active Directive rules.