Nicola Osypka, a German business, has sold medical equipment used for surgery on infants in Europe for many decades. However, new EU rules forced Osypka to take tough decisions.
Companies must obtain new medical equipment certificates under the regulations to avoid another health scandal such as that of 2010 with ruptured breast implants caused by Poly Implant Prothese.
Osypka claims that the father of Osypka, Peter Osypka, founded the company in 1977. The firm has since withdrawn five lines devices from the EU. Some were sold for over 30 years.
Osypka stated that a law passed to prevent a criminal firm’s actions 10 year ago is now threatening patients’ lives and European manufacturing locations.
Is this what the EU really wants for its citizens?
Osypka AG was one of eight companies Reuters spoke to. Getinge, a Swedish manufacturer of medical equipment, is also among them. They are either withdrawing their devices from the EU or stopping production due to the high cost required to meet the regulations.
Some companies claim that the product they cut has no effect on profits or patients, but others argue that some devices have to be reintroduced, which is what doctors and other medical professionals agree with.
The EU’s Medical Devices Regulation, (MDR) came into force in May 2021. All medical devices must comply with stricter safety standards, including implants, prosthetics and blood glucose meters, and sometimes, new clinical trials.
All eight manufacturers agreed that the new requirements are more time-consuming than the previous system.
According to companies, costs have risen by as much as three to ten times. Some companies are simply letting their product certifications lapse. This means that hospitals across the EU cannot use their products.
In response to Reuters’ queries, the EU Commission stated that it is concerned by the speed of implementation and will do everything it can to make sure patients have the access they require.
Reuters spoke with three physicians, two regulator experts, and two associations of medical professionals. They all said that the new regulations were causing widespread disruptions and making it difficult to find the right equipment.
In Germany, Belgium, and Austria, doctors said that they could not provide the same quality care in certain cases because routine devices were unavailable.
According to the Standing Committee of European Doctors, a coalition of medical associations across Europe, hospitals in Austria and Denmark reported shortages of crucial devices.
Reuters was told by France’s National Medical Regulator (ANSM), that shortages in various devices were affecting the country’s healthcare system, partially due to the new law.
Nicola Osypka is a molecular biologist. She said that she sat down to discuss the details of niche products such as a tiny catheter to preserve newborns without functioning heart valves until they can undergo surgery.
She stated that these types of products can be very beneficial to patients. However, we are unable to afford half a million euros for a study.
It is also painful to know that Osypka can’t afford the costs of preparing the application for a novel product, which has been tested in clinical trials.
According to Reuters, the company’s latest stent was created over 8 years. It was successfully tested on 19 infants in Germany during a trial.
Palliare is a small Irish manufacturer of medical equipment. John O’Dea is the chief executive and has taken on the cost to bring his new laparoscopic device, for abdominal or pelvic surgery, onto the Irish market.
O’Dea estimated that the equipment approved by the U.S. Food and Drug Administration two years ago will cost approximately 100,000 Euros. The entire process took over a year and half.
He said that under the previous system it was about 15,000 Euros and several months to obtain approval for a similar device.
This is just the latest setback to the second largest medical device market in the world, valued at more than $150 Billion. It is currently reeling from rising energy costs and unpredicted supply chains after pandemic lockdowns.
In an email statement, a spokesperson for EU Commission stated that currently there are not enough agencies (known as notified body) to do the job of recertifying products. However, device manufacturers had not been prepared adequately.
According to a spokesperson, Brussels has authorized 36 agencies. It is currently considering 20 additional applications.
Tom Melvin is an associate professor at Trinity College Dublin in medical device regulatory affairs. He said that there had been nearly 100 of these agencies 10 years ago, under the old system.
The EU Health Commissioner made a concession on December 9th, allowing companies to extend the May 2024 deadline to conform to the new law. This would prevent any shortages.
An amendment to the law will be required to extend the extension. This would need to be approved both by the European Council (or Parliament), which won’t happen before next year.
A delay might mean that some devices won’t be cut in short-term, but it wouldn’t address the high cost and logjams holding firms back from going through this process. Executives such as Frank Matzek (Vice President of Regulation and Governmental Affairs at Biotronik), a Berlin manufacturer of cardiac devices, stated that it was not the right thing to do.
This month, data from the EU Commission shows the extent of the problem.
There were approximately 25,000 certificates under the old system. Manufacturers have so far submitted approximately 8,000 applications to the new system, with less than 2000 of these approvals.
Multiple devices and sometimes entire product lines can be covered by certificates. It is difficult to determine the potential impact on products. According to industry experts, there are approximately 500,000 devices sold within the EU.
Even companies that have more money and are better equipped to handle tough international regulations will be amazed at the system’s cost and complexity.
Mikael Johansson overseeing MDR implementation, stated that Getinge has received new certificates covering 20% of its products.
The company had to review its portfolio in 2018 and remove about one third of Getinge’s devices from its hundreds.
The cull, he said was healthy in that it eliminated products without much profit. However recertification has proved more difficult and took longer than anticipated.
Some companies push ahead while others let certifications slip.
Andreas Kohl is the German stent- and catheter maker AndraTec. He said that he will drop 2 or 3 devices as he can’t afford to submit for six of his current products in Europe.
According to Reuters, Balton, Poland, told its customers that it was going to discontinue over a dozen products in October, which included catheters and stents for coronary angioplasties, pacing electrodes and pacing. This decision was made due to costs associated with complying to the new law.
The company didn’t respond to our requests for comment.
According to doctors, the most striking example of how company decisions have affected patients with rare conditions is the use of catheters on babies who are suffering from heart disease.
Marc Gewillig is the director of paediatric cardiology, University Hospital Leuven. He said that he lost nearly all necessary devices and had to make do with three children.
He said that he needed to insert a catheter through his groin to reach the atrial septum.
This procedure can usually be completed within 5 minutes after birth. However, without the preferred device, the doctor must move the baby to another hospital. It will delay the process by 30 minutes.
He said, “Those are just minutes for a baby with very little oxygen getting to its brain.” We’re moving backwards in medicine by 20-30 years.