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.
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.
With demand for EU notified body medtech services fast outstripping capacity, three well-known notified body experts explain how they are battling to make the new regulatory system work.
Latest figures published by the European Commission show some progress can be expected soon when it comes to notified body designations under the Medical Device Regulation, but very little under the IVD Regulation.
Unprecedented silence from the EU when it comes to news relating to the implementation of the Medical Device and IVD Regulations is disconcerting as compliance pressures mount.
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