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March 23, 2026

Health September 11, 2023 2 mins read

EU Urged to Loosen Stringent Regulations on Medical Equipment

Health ı By Gabrielle Seunagal

244 0 Comments

Serious rules and regulations for doctors and other medical practitioners exist globally for good reason.

Without careful guidelines, combined with years of training, people would lack the assurance that their healthcare providers know what they're doing and have the necessary expertise to care for them.

While rules and regulations certainly have their place in the medical field, there's always the other side of the coin. For instance, some guidelines can be so strict that they have the opposite intended impact and miss certain key factors.

This is a matter that one Ireland-based congenital cardiologist is currently sounding the alarm about.

A critical appeal to the EU

As things currently stand, congenital cardiologist Damien Kenny has informed the European Union (EU) that its Medical Devices Regulation (MDR) is backfiring and leading to a shortage of necessary medical equipment.

Under the MDR, mandatory recertification of medical tools is necessary to protect the general public from dangerous or defective products.

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.

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.

The EU is aware of the concerns that have been raised. In a public statement, the union confirmed it plans to hold forthcoming meetings as a means of finding solutions to the aforementioned problems.

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Gabrielle Seunagal
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Gabrielle Seunagal

Gabrielle Seunagal is a full-time freelance writer, editor, and voice actor, who worked with USA Herald from June 2017 to November 2024. She is passionate about fitness, travel, and combating human rights abuses like human trafficking and child marriage.

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