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Cardiologist Damien Kenny didn’t sleep well in early November.
He only had two special devices left on the shelf to save the lives of babies born with a congenital heart problem.
“If I had more than two babies in the next week or two, which can sometimes happen, theoretically the third baby would not get the treatment. I didn’t know where to go,” said Kenny, who works at a Dublin hospital.
The growing shortage of medical devices across Europe threatens many life-saving medical procedures. The cause? The devil in Europe details Medical Device Regulation (MDR)which sets new rules on device certification and came into effect in May of last year.
“MDR should be the top story on every news outlet in every country,” said the owner of the company that makes the final product Kenny uses to treat babies with this rare heart condition.
“It is sad to know that the patients, many of them newborns, will die, because they will have been born under MDR and not before. This is a fact,” the owner said. This person requested anonymity due to concerns that public speaking could impact the evaluation of the company’s products.
The MDR was supposed to protect against another public health scandal like breast implants or vaginal mesh. But, by requiring all medical devices to undergo a costly recertification process by May 2024, the new rules have inadvertently triggered a new public health emergency: a looming cliff in unavailable devices.
Doctors say certain products are becoming more difficult to obtain as developers pull out of the EU market due to new rules or get stuck in certification. In the case of the infant heart device, two other manufacturers pulled out, leaving the only remaining product in desperate shortage.
The European Commissioner for Health, Stella Kyriakides Announced on Thursday that the Commission will propose solutions at a meeting of health ministers on December 9, including amending the regulation. But nothing is likely to be approved until next year, according to a Commission official, leaving a widening gap for many products whose old certificates have expired and have yet to get a new one.
The scale of the problem is immense.
There are around 25,000 medical device certificates approved for use in the EU, all of which must undergo a new clinical evaluation and receive a new certificate by May 26, 2024. So far, only ones have been reissued. around 2000 certificates.
But the number of affected products is much higher since one certificate can cover up to 100 similar products; more than 500,000 medical devices are used across Europe.
One problem is the expense. Under MDR, the cost of testing has gone up, a lot.
For example, the cost of continuing to supply Europe with a specific catheter increased 10-fold under the new rules, according to a company document seen by POLITICO.
Licensing the catheter in the US involves a one-time cost of around $3,000, and in Canada, a one-time payment of around 10,000 Canadian dollars (CAD) plus a renewal fee of 381 CAD each year. The EU fee is over $143,000 every five years.
But that’s not the only problem. Retesting began when the regulation went into effect in May 2021, but the capacity simply isn’t there among so-called notified bodies — the often private companies licensed to certify devices — to keep up with the apps, according to both developers. and the European Commission. Only 34 of 62 of these bodies have so far been authorized to operate under the new rules.
Assessments are also taking much longer, up to 18 months or even two years. That’s more than double the previous rule, and compares to about 30 days in the US for infants’ heart devices.
Added to this, many certificates must be reissued before the May 2024 deadline, as their five-year certificates expire before then. There are already 2,000 products with older certificates expiring this year, with twice that number due next year.
Solving the certificate expiration problem is the “big elephant in the room,” said Oliver Bisazza, head of industrial policy and external affairs at MedTech Europe, the device lobby group. Products are already disappearing from the market because their certificates have expired and notified bodies are under too much pressure to review them in time, he said.
Lack of predictability
In addition to these obstacles, there is a lack of predictability, argued Tom Melvin, Associate Professor at Trinity College Dublin. Developers must now submit sufficient clinical data, but the requirements for this data “are not really defined” and are “subject to interpretation,” he said.
“If it makes the path to market more challenging, or even less predictable, that can have a really chilling effect,” said Melvin, who until last spring was a regulator in Ireland.
For Melvin, the biggest risks are for devices that are used very rarely: for orphan (rare) conditions, products that are used off-label for unintended purposes, or where there are no alternatives.
It is especially worrying for low-margin products that have been used for decades without issue and are now required to provide clinical data to maintain access to the EU market.
“If something has been on the market for 20 years… if the product doesn’t work, it will self-select,” argued Kenny, the cardiologist. “I’m not saying there shouldn’t be regulation,” but it should be proportionate, he added, and not take a “one size fits all” approach.
Currently, the certificate of the device that he uses in neonates will expire next year. Not having the right device in his hands when he needs it “scars the hell out of anyone who works in our field,” he said. “The consequences are…in many ways unthinkable for us.”
That’s why the industry, doctors and everyone involved in this space is speaking up, he added.
Ahead of December’s Health Council, more than 200 companies signed a letter, seen by POLITICO, calling for urgent changes to legislation to prevent large numbers of medical devices from disappearing from the market forever.
The letter calls for three immediate changes to the legislation: Extend the validity of existing certificates; for temporary certificates to be used under the new regulation while companies collect more data needed to meet the requirements; and to allow continued sale of existing devices beyond May 2025, if they were manufactured before May 2024.
in a letter To President Ursula von der Leyen, the conglomerate of medical associations CPME said that “in some countries, up to 75 percent of medical devices are at risk of becoming unavailable.” They expect “big disruptions in the near future” and call for similar urgent legal changes.
While a number of non-legislative steps were agreed in August to ease the burden on notified bodies, companies, doctors and some EU countries believe more needs to be done. And fast.
It’s a “big emergency to be resolved,” but there is a precedent, said Bisazza, who will take over as CEO of MedTech Europe in January.
The Commission, the Council and Parliament quickly agreed to delay the implementation of the regulation of In Vitro Medical Devices during the pandemic, modifying the text to allow the gradual application of the law according to the level of risk of the device. “In fact, we would support doing something like that,” he said.
While Kyriakides did not reveal what legal changes will be on the table, he hinted that national repeals to close the gap between certificate expiration and reissue may be considered at the EU level.
Fortunately for Kenny and the children born that week in early November, there weren’t the three cases of life-threatening congenital heart disease in Ireland that would have put a third baby at significant risk. And since then a new batch of devices has been delivered.
And, if the Commission, Council and Parliament can agree to change the regulation quickly enough, the hope is that this risk will be avoided again.
Carlo Martuscelli contributed to this reporting.