Bungled EU medical device rules put lives at risk

Cardiologist Damien Kenny didn’t sleep well in early November. He had just two special devices left on the shelf to save the lives of babies born with a congenital heart problem.

“If you had more than two babies come in over the next week or two — which can happen sometimes — theoretically, the third baby would not get the treatment. I didn’t know where to go,” said Kenny, who works at a hospital in Dublin.

The growing scarcity of medical devices across Europe is threatening many lifesaving medical procedures. The cause? The devil in the details of Europe’s Medical Devices Regulation (MDR), which sets out new rules around device certification and came into effect in May last year.

“MDR should be the lead story on every newscast in every country,” said the owner of the company that manufactures the final product used by Kenny to treat babies with the rare heart condition.

“It’s sad to know that patients, many of them newborns, will die, because they will have been born under MDR and not before. This is a fact,” said the owner. This person requested anonymity due to concerns that speaking publicly might have an impact on the assessment of the company’s products.

The MDR was supposed to protect against another public health scandal like breast implants or vaginal meshes. But, by requiring all medical devices to undergo an expensive re-certification process by May 2024, the new rules have inadvertently triggered a new public health emergency — a looming cliff edge in unavailable devices.

Clinicians say certain products are becoming harder to source as developers either withdraw from the EU market due to the new rules or get stuck in certification. In the case of the heart device for babies, two other manufacturers have pulled out, leaving the sole remaining product in desperately short supply.

Europe’s Health Commissioner 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, according to a Commission official, nothing is likely to be approved until next year, leaving a widening gap for many products whose old certificates have expired and which haven’t yet obtained a new one.

500,000 devices
The scale of the problem is immense.

There are around 25,000 medical device certificates approved for use in the EU, and all of them need to undergo a new clinical assessment and receive a new certificate before May 26, 2024. So far, only around 2,000 certificates have been re-issued.

But the number of products affected is far greater since one certificate can cover up to 100 similar products; there are more than 500,000 medical devices used across Europe.

One problem is expense. Under MDR, the cost of the assessment has gone up — a lot.

For example, the cost of continuing to supply Europe with one specific catheter has increased 10-fold under the new rules, according to a company document seen by POLITICO.

To license the catheter in the U.S. entails a one-off cost of around $3,000, and in Canada, a single payment of around 10,000 Canadian dollars (CAD) plus a 381 CAD renewal fee each year. The EU fee is over $143,000 every five years.

But that’s not the only problem. The new assessments began when the regulation came into effect in May 2021, but there simply isn’t the capacity among the so-called notified bodies — the often-private firms licensed to certify devices — to keep up with applications, according to both developers and the European Commission. Just 34 out 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 twice as long as under the previous rules, and compares with around 30 days in the U.S. for the babies’ heart device.

Added to this, many certificates need reissuing sooner than the May 2024 deadline since their five-year certificates expire before then. There are already 2,000 products with older certificates expiring this year, and double that number expiring next year.

Solving the issue of expiring certificates is the “big elephant in the room,” said Oliver Bisazza, head of industrial policies and external affairs at MedTech Europe, the devices lobby group. Products are already disappearing from the market because their certificates have expired and notified bodies are too stretched to review them in time, he said.

Lack of predictability
On top of these hurdles there is a lack of predictability, argued Tom Melvin, associate professor at Trinity College Dublin. Developers have to now present sufficient clinical data, but the requirements of this data are “not really further defined” and are “subject to interpretation,” he said.

“If you make the market access pathway more challenging, or even if it’s just less predictable, that can have a real chilling effect,” said Melvin, who until last spring was a regulator himself, in Ireland.

To Melvin, the biggest risks are for devices that are used very rarely — for orphan (rare) conditions, products used off-label for unintended purposes, or where there are no alternatives.

It’s especially concerning for low-margin products that have been in use for decades without issue and are now required to deliver clinical data to maintain access to the EU market.

“If something’s been on the market for 20 years … if the product’s not working it would self-select itself out,” argued Kenny, the cardiologist. “I’m not saying there shouldn’t be regulation,” but it needs to be proportionate, he added, and not take a “one size fits all” approach.

At present, the certificate for the device he uses in neonates will expire next year. Not having the right device in your hands when you need it “scares the hell out of anybody who works in our field,” he said. “The consequences are … in many ways unthinkable for us.”

That’s why industry, physicians and everybody involved in this space are speaking up, he added.

Stepping up
Ahead of the December Health Council, more than 200 companies have signed a letter, seen by POLITICO, pleading for urgent changes to the legislation to prevent large numbers of medical devices from disappearing from the market for ever.

The letter calls for three immediate changes to the legislation: For validity of existing certificates to be extended; for temporary certificates under the new regulation to be used while companies compile further data needed to meet the requirements; and to allow the 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 medical associations conglomerate CPME said that “in some countries, up to 75 percent of medical devices are at risk of becoming unavailable.” They expect “major disruptions in the near future,” and call for similar and urgent legal changes.

While a series of non-legislative steps was agreed in August to ease the burden on the notified bodies, companies, doctors and some EU countries believe more needs to be done. And quickly.

It’s a “big emergency to solve” but there is precedent, pointed out Bisazza, who steps up to be CEO of MedTech Europe in January.

The Commission, Council and Parliament swiftly agreed to delay the implementation of the In Vitro Medical Devices regulation during the pandemic, amending the text to allow the phased application of the law depending on the device’s risk level. “We would indeed support doing something like that,” he said.

While Kyriakides did not reveal what legal changes will be on the table, she hinted that national derogations to bridge the gap between certificates expiring and being reissued may be considered at EU level.

Thankfully for Kenny, and the children born that week in early November, there weren’t the three cases of the life-threatening congenital heart condition in Ireland that would have put a third baby at significant risk. And a new batch of devices has since been delivered.

And, if the Commission, Council and Parliament can agree to amending the regulation quickly enough, the hope is that this risk will be averted again. POLITICO