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LONDON, Dec 19 (Reuters) – Nikola Osipka’s German company has been selling medical devices used to operate on newborn babies in Europe for decades, but new European Union rules have forced it to make tough decisions.

Under regulations designed to prevent another health scandal like the one involving ruptured breast implants made by Poly Implant Prothese in 2010, the companies must apply for new certifications for their medical devices.

But Osipka says the small company founded by his father, Peter, in 1977, can’t afford the process and has pulled five lines of devices sold in the EU, some of which are more than 30 years old.

“A law created 10 years ago to stop the activities of a criminal organization is now putting the lives of patients, including children, and European factories at risk,” Osipka said.

“Is this what the EU wants for its citizens?”

Osypka AG is one of eight companies Reuters spoke to, including Swedish medical equipment maker Getinge ( GETIb.ST ), which are pulling devices from the EU market or have stopped production because of the costs required to comply with the rules.

While some companies say the products they cut have no impact on patients or profits, others say some of the removed devices are important, and doctors agree.

Under the EU’s Medical Device Regulation (MDR), which came into force in May 2021, all medical devices, from implants and prostheses to blood glucose meters and catheters, must meet stricter safety standards, sometimes with new clinical trials.

The eight manufacturers all said the requirements extend the time it takes to obtain certification for a product line to two and a half years, compared to several months under the old system.

Costs have also increased, from three to 10 times, the companies said. As a result, some simply let their product certifications lapse, meaning EU hospitals can no longer use their devices.

The EU Commission, in response to questions from Reuters, said it was concerned about the pace of implementation of the new rules and would do everything possible to ensure patients have access to the medical devices they need.


Reuters also spoke to two medical associations, three doctors and two regulatory experts, and like the companies, they said the new rules are causing widespread disruption and shortages of critical equipment.

Doctors in Austria, Belgium and Germany said that in some cases they could not provide their standard quality care because devices for routine procedures were no longer available.

The Standing Committee of Physicians in Europe (CPME), a group of national medical associations, told Reuters that hospitals in Austria and Denmark had reported shortages of critical equipment.

France’s national medical regulator (ANSM) told Reuters the country’s healthcare system was suffering from shortages of various types of devices, in part because of the new law.

Nikola Osipka, a molecular biologist, said he sat down with the staff to run the numbers on their niche products, such as a small catheter used to keep babies with malfunctioning heart valves alive until surgery can be performed.

“These types of products are completely beneficial for these patients, but we cannot afford the half a million euros it takes to conduct a clinical trial, even though these products have been on the market for 30 or 40 years,” he said.

Equally unfortunate is the fact that Osypka cannot afford the costs, estimated at one million euros ($1.1 million), to prepare an innovative product application that has already passed clinical trials.

The company’s new stent for infants has been in development for eight years, and doctors have successfully used it on 19 infants in a trial in Germany, according to results seen by Reuters.

John O’Dea, chief executive of Palliare, a small Irish medical equipment maker, is so eager to bring his company’s new laparoscopic device to market for abdominal or pelvic surgery that he has swallowed the costs.

The process has taken a year and a half so far, and O’Dea estimates the total cost to be around €100,000 for the equipment, which was approved by the US Food and Drug Administration two years ago.

Under the old system, it took about 15,000 euros and several months to get a similar device approved, he said.


The costly approval process is the latest blow to the world’s second-largest medical device market, worth more than $150 billion, which is already reeling from rising electricity bills and an unpredictable supply chain following pandemic lockdowns.

An EU Commission spokesman said in an emailed statement that there are currently not enough agencies, known as notified bodies, to do the work of re-certifying products, although device manufacturers have also not been sufficiently prepared for the change.

Brussels has authorized 36 agencies and is considering another 20 applications, the spokesman said.

Tom Melvin, associate professor of medical device regulatory affairs at Trinity College Dublin, said a decade ago there were about 100 such agencies in the old system.

In a major concession, the EU’s health commissioner proposed on Dec. 9 to delay the May 2024 deadline for companies to comply with the new law until 2028 to prevent shortages.

An extension would require a law change to be approved by the European Council and Parliament, which would not happen until next year.

While the delay will mean some devices won’t make the cut in the short term, it won’t address the bottlenecks and high costs that force companies through the process, according to Frank Matzek, Biotronik’s vice president of regulatory and government affairs. The manufacturer of heart devices in Berlin said.

EU Commission data released this month shows the scale of the problem.

About 25,000 certificates are valid under the old system. So far, manufacturers have submitted nearly 8,000 applications under the new system, but fewer than 2,000 have been approved.

The certifications cover multiple devices, and in some cases entire product lines, making it difficult to estimate the number of potentially affected products. Industry experts estimate that around 500,000 different devices are sold in the EU.


Even big companies with deeper pockets and more experience dealing with tough global regulations say they are staggered by the complexity and cost of the new system.

Getinge, which makes products for surgery, intensive care and sterilization, has new certificates for about 20% of its portfolio and believes it is on track to meet the deadline, said Mikael Johansson, the executive overseeing the MDR rollout.

But that work began in 2018, required a complete overhaul of the company’s portfolio and led to the removal of about a third of Getinge’s products from hundreds of devices.

He said the cull was “healthy” in that it removed products without impacting profits, but restocking the rest was more demanding and took much longer than expected.

But as some companies move forward, others allow certifications to be revoked.

Andreas Kohl, who runs stent and catheter maker AndraTec in Germany, said he plans to drop two or three devices because he cannot afford to apply for all six of his products currently sold in the EU.

Poland-based Balton told customers in October that it would phase out more than a dozen products, including catheters and stents used for coronary angioplasty and pacing electrodes, due to costs and other difficulties in complying with the new law, according to an email seen by Reuters. .

The company did not respond to requests for comment.

Doctors say the clearest example of the impact of the company’s decisions has been on devices for rare conditions, such as catheters used in infants with heart problems.

Mark Gevilig, director of pediatric cardiology at Leuven University Hospital in Belgium, said he lost access to about a dozen devices needed for the procedure, forcing him to improvise on three infants.

For one procedure, he said, he had to use a catheter to access the atrial septum through the groin, rather than through the umbilical cord with a balloon catheter.

The procedure is usually done within five minutes of birth, but without the preferred device, she has to move the baby to another part of the hospital, delaying it for 30 minutes.

“Those are minutes in a child whose brain is getting less oxygen,” he said. “We will be back in medicine for 20-30 years.”

($1 = 0.9405 EUR)

Reporting by Maggie Fick; Additional reporting by Tasilo Hummel in Paris; Editing by Josephine Mason and David Clarke

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