EU Urged to Loosen Stringent Regulations on Medical Equipment

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However, Kenny warns the MDR has become so strict that certain manufacturers simply discontinued supply production, rather than taking on elevated costs and long amounts of time.

Kenny, who works in Dublin, warns that as a result, the lack of necessary equipment places newborn babies and others at risk. So far, medical practitioners in his community have begun leveraging the available supply of stents, tiny balloons, and catheters.

Yet, if ongoing shortages persist, the congenital cardiologist believes he and his colleagues won’t have the necessary resources for procedures that involve treating heart defects in newborns.

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As a result, some of these babies will inevitably lose their lives.

A fine line to walk

Kenny and others like him recognize the MDR has its place in the healthcare field. Hence, the congenital cardiologist is not calling to completely do away with this regulation.

Instead, it is his view that MDR should avoid taking a one-size-fits-all approach when it comes to various medical tools.