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In 2010 a medical device scandal in France set the stage for a new European Union medical device regulation that, according to most experts in the medical device community, may cause more damage than the problem it was intended to address. An unreasonable deadline, lack of notified bodies to perform audits, and exorbitant costs are driving medical device manufacturers from the EU market, say experts—at a minimum leading to increased medical costs, but, some fear, potentially leading to shortages.
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The well-meaning but reactionary enactment of Regulation (EU) 2017/745 and Regulation (EU) 2017/746, meant to address some of the issues raised by the 2010 PIP implant scandal, has placed medical device manufacturers in Europe and the United States in the untenable position of having to meet a standard—which literally cannot be met by all affected manufacturers in the time allowed—or be forced to remove their products from the European market.
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EU Med Tech frozen in 2021
The backlog of legacy MDD devices waiting to get approved clogs the system, preventing new devices from achieving timely approvals. Meanwhile under the transition rules MDD devices cannot implement any significant changes, since May of 2021. The combined effect is that medical technology for Europe is basically frozen at 2021, making Europe a medtech backwater. The commission, while being unreasonably strict with manufacturers with respect to the much vaunted State of the Art in applied standards, itself has elected to freeze its State of the Art for medical care to 2021 levels. The European peoples deserve better.
This was one of the most
This was one of the most well-written and extraordinarily comprehensive articles about the slow-motion train wreck called MDR, which, through a contemporary lens can be clearly seen for what it is: a power-grab for proponents of central control.
The most tragic victims will be European citizens, especially within the vulnerable healthcare demographics: the aged (who coincidentally have the highest healthcare costs - hmmm) and those thousands suffering individual diseases with low-occurrence populations or relying on medical devices with such low revenue that companies find them too expensive to continue carrying in the EU.
In many ways, the US stands to benefit hugely, although the author adroitly points out that many US manufacturers & employees will suffer too, due to reduced revenue in the EU and diminished device sales there.
The current MDR extension is merely a pause button that prolongs the suffering.
MDR should be terminated immediately and those responsible for it's enablement should be banished from any future responsibility over human life.
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