Medicine New EU approval rules create bottlenecks in medical products

London, December 21 – Osypka AG from Rheinfelden in Baden-Württemberg has been selling medical equipment for operations on newborns for decades. But due to new EU rules, owner Nicola Osypka is faced with difficult decisions. According to the EU regulation, which entered into force in May 2021, all medical equipment – from implants and prostheses to blood glucose meters and catheters – must meet stricter safety criteria. This also includes new clinical studies. “We cannot afford half a million euros for a clinical study,” says CEO Osypka. Your company makes niche products like tiny catheters for newborns that have been on the market for 30 or 40 years.

Reuters spoke to a further seven medical device manufacturers who have withdrawn products from the EU market or stopped manufacturing altogether due to the new rules. The reason is the price of the new certification, which is three to ten times higher than under the old rules. The time it takes for a product to be approved is also significantly longer – up to two and a half years instead of just a few months. As a result, some manufacturers are simply phasing out their product certifications. As a result, hospitals in the EU are no longer allowed to use this medical technology.

With the new rules, the EU will prevent another health scandal, such as the one triggered by the French company Poly Implant Prothèse in 2010 in connection with burst breast implants. “A law designed to combat illegal actions by a company ten years ago is now endangering the lives of patients, including children, and European production sites,” complains molecular biologist Osypka, whose father founded her company in 1977. Now she has drawn five product lines sold in the EU back. When asked, the European Commission said it would do everything in its power to ensure patients had access to the medical equipment they needed.


The costly approval process is the latest blow to the world’s second-largest medical technology market, worth more than $150 billion. The industry is already suffering from rising energy costs and supply chain problems as a result of the corona pandemic. Even large companies with deeper pockets and experience with regulatory processes in other countries struggle with the complexity of the new system. The Swedish group Getinge has now obtained new certificates for around 20 percent of its hundreds of products.

However, he has sorted about a third of his product range. John O’Dea, head of the small Irish company Palliare, is determined to bring his new abdominal imaging instruments to the EU market and is willing to accept costs estimated at €100,000. The certification process has been going on for a year and a half for a product that was approved by the US health authorities two years ago.

Reuters also spoke to two health associations, three doctors and two regulatory experts on the issue. According to your statements, the new rules have serious consequences and cause bottlenecks in important medical products. The Standing Committee of European Physicians (CPME) stated that hospitals in Austria and Denmark had reported shortages of certain devices. France’s national medical regulatory authority ANSM also sees bottlenecks in various medical devices, which is partly due to the new law.

At the University Hospital in Leuven, Belgium, Marc Gewill, head of pediatric cardiology, says he has lost access to nearly a dozen devices he needs for procedures. This forced him to improvise as he treated three babies with heart problems. Normally, the procedure is performed within five minutes of birth, but without the preferred device, he has to move the baby to another part of the hospital, delaying the procedure by 30 minutes. “These are minutes in a child when the brain gets a little oxygen,” he says.


One problem is the bureaucratic capacity in the EU to issue the new certificates. According to a spokesperson for the European Commission, there are currently not enough agencies doing this. At the same time, manufacturers had not adequately prepared for the change. Brussels has approved 36 agencies and is processing another 20 applications, the spokesman added. A decade ago there were almost 100 such agencies under the old system, says Tom Melvin, associate professor of medical device regulation at Trinity College Dublin.

EU Health Commissioner Stella Kyriakides therefore proposed in early December to postpone the transition period for compliance with the new law from May 2024 to 2028 to avoid bottlenecks. The extension requires an amendment to the law, which must be approved by the European Council and the Parliament. It won’t happen until next year.

A postponement will mean that some units will not be taken off the market in the short term. But that would not change the long procedures and high costs, says Frank Matzek from the Berlin heart device manufacturer Biotronik. These prevented companies from even starting the certification process. Data released this month by the European Commission shows the extent of the problem: While there are about 25,000 certificates under the old system, manufacturers have so far submitted about 8,000 applications under the new regulation, of which fewer than 2,000 have been approved.

New EU approval rules cause bottlenecks in medical devices

Source: Reuters

Symbol photo: image of _Penelope on Pixabay

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