Updated: EU IVD Regulation Guidance On Significant Changes Now Available
With just a few weeks to go until the IVD Regulation fully applies, much-needed guidance has been published which discusses “significant changes” for legacy IVDs
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Only one new standard has been added to the official list of standards recognized in the context of the EU IVD Regulation in the latest update. The good news is that it is arguably one of the most needed standards by the IVD industry after the medtech quality management standard, ISO 13485.
The regulation of products on the drug/device borderline has always been complex. New EU guidance aims to provide clarification, but some difficult and nuanced decision-making is still left to the manufacturer.
Given the ongoing conflict in Ukraine, EU medtech notified bodies have been told to comply with sanctions intended to hurt companies based in Russia and Belarus.