Why And How Last-Option, Essential Devices Must Now Be Identified As A Matter Of Urgency

With the axe falling on a growing number of essential legacy products, Tom Melvin explains why a plan around derogations for devices falling through the regulatory crack is now critical.

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Newborns are among those at risk from devices exiting the market • Source: Shutterstock

Legacy devices that did not make the 26 May 2024 deadline by which manufacturers should apply to a notified body had to be removed from the market regardless of how safe they have proved and how essential they are.

And there could be a fresh wave of casualties from 26 September, following the Medical Device Regulation

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