London, December 21 – Osypka AG from Rheinfelden in Baden-Württemberg has been selling medical equipment for newborn surgeries for decades. But due to new European Union (EU) regulations, owner Nicola Osypka faces some tough decisions. According to EU regulations that came into force in May 2021, all medical devices – 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 newborn catheters that have been around for 30 or 40 years.
Reuters spoke to seven other medical device makers who have withdrawn products from the EU market or stopped manufacturing altogether due to the new regulations. The reason cited is the cost of the new certification, which is three to ten times higher than under the old regulations. The time to product approval is also significantly longer, up to two and a half years instead of just a few months. As a result, some manufacturers simply remove their product certifications. As a result, EU hospitals are no longer allowed to use this medical technology.
With the new rules, the EU wants to avoid another health scandal, like the one triggered by the French company Poly Implant Prothèse in 2010 in connection with the rupture of breast implants. “A law aimed at combating the illegal actions of a company ten years ago now puts the lives of patients, including children, and European production sites at risk,” laments molecular biologist Osypka, whose father founded her company in 1977. Now she has retired five product lines sold in the EU. When asked, the European Commission said it would do everything in its power to ensure patients had access to the medical devices 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 issues due to the corona pandemic. Even large companies with deep pockets and experience of regulatory processes in other countries are grappling with the complexity of the new system. The Swedish group Getinge has now obtained new certificates for around 20% of its hundreds of products.
Still, it has sorted about a third of its product line. John O’Dea, boss of the small Irish company Palliare, is determined to bring his new abdominal imaging instruments to the EU market and is ready to accept costs estimated at 100,000 euros. The certification process has been going on for a year and a half for a product that was approved by 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 for important medical products. The Standing Committee of European Doctors (CPME) said Austrian and Danish hospitals had reported shortages of some devices. ANSM, France’s national medical regulator, is also seeing bottlenecks in various medical devices, 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 when treating three babies with heart problems. Normally, the procedure is done within five minutes of birth, but without the preferred device, he has to move the baby to another part of the hospital, which delays the procedure by 30 minutes. “Those are minutes in a child where the brain gets little oxygen,” he says.
One of the problems is the bureaucratic capacity of 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 sufficiently prepared for the change. Brussels has approved 36 agencies and is examining 20 other files, added the spokesperson. A decade ago, there were nearly 100 such agencies in the old system, says Tom Melvin, associate professor of medical device regulation at Trinity College Dublin.
European Commissioner for Health Stella Kyriakides therefore proposed in early December to postpone the transition period to comply with the new law from May 2024 to 2028 in order to avoid bottlenecks. The extension requires a change in the law, which must be approved by the European Council and Parliament. That won’t happen until next year.
A postponement would mean that some devices will not be taken off the market in the short term. But that wouldn’t change the lengthy procedures and high costs, says Frank Matzek of Berlin-based heart device manufacturer Biotronik. This has even prevented companies from starting the certification process. Data released this month by the European Commission shows the scale of the problem: while there are around 25,000 certificates under the old system, manufacturers have so far submitted around 8,000 applications under the under the new regulations, of which less than 2,000 have been approved.
New EU approval rules cause bottlenecks in medical devices
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