Tuttlingen – The EU-MDR has been mandatory for medical technology companies since May 26, 2021. Increasing patient safety and at the same time enabling innovations, the set of rules has written this goal into its own register. Doctors sometimes experience exactly the opposite. They report from their environment - about ideas, hopes, and above all disappointments.
Prof. Dr. medical Brigitte Stiller is Medical Director at the Clinic for Congenital Heart Defects and Pediatric Cardiology at the University Heart Center Freiburg-Bad Krozingen. In a calm, gentle tone, the pediatric cardiologist and intensive care physician describes how her team performs cardiac catheterizations on newborns. As with premature babies, with a body weight of only two kilograms, the blood vessels, which are barely two millimeters in size, are punctured in the groin or on the neck and then special cardiac catheter tubes are used to penetrate to the heart. How careful you have to work in the groin so as not to jeopardize the arterial blood supply of the whole leg. How to work in young hearts with an accuracy of a fraction of a millimeter in order to successfully rupture closed valves, keep vital vascular connections or critical vascular constrictions open for a long time with individually measured stents. How life gets a second chance before it really begins.
Brigitte Stiller weighs the words with the same care with which she treats her little patients. But the voice changes when the medical director starts talking about the baby stent. She raves. A vascular support that grows with the patient has been developed in cooperation with a medium-sized medical technology company. So far, stents have had to be removed after a few years as part of a major open heart operation using a heart-lung machine. The baby stents, on the other hand, can be inserted via a femoral artery and, depending on the child's physical development, can still be expanded with a balloon after a few years. “The flexible hook and loop mechanism is brilliant. It was specially developed for very small babies so that they can get a gentle start in life,” says Brigitte Stiller. He could make the first intervention so much easier. Reduce the number of risky follow-up interventions. Increase the chances of survival. "Could." Brigitte Stiller must remain in the subjunctive. Although multi-centre studies have already been approved, the additional costs for the company are no longer in proportion to the possible proceeds. "A baby stent is not a mass product, but for a handful of procedures per year," reminds Brigitte Stiller. Further development is suspended. Her voice is matter-of-fact again. But every syllable breathes deep disappointment. "It's a shame we can't manage that."
When the EU-MDR was launched in 2017, the memory of the breast implant scandal was still fresh. It resonates with the new specifications. "Patient protection is always and undeniably the top priority," agrees Julia Steckeler, Managing Director of MedicalMountains GmbH together with Yvonne Glienke, "but if patient protection is at the expense of progressive patient and supply security, then something is wrong in the system." Research and development have been noticeably shut down, reports Yvonne Glienke from the network, "because there are no prospects as to whether the investment in innovation will eventually pay off."
Nobody can say exactly how many promising products and processes fall by the wayside. This can be said more precisely for existing products, to which the problems of new developments can be mirrored. Conformity is not declared for "lifetime", but must be re-evidenced regularly. With the EU-MDR, the requirements for documentation and evidence have also been significantly tightened here - even if a product has been on the market for decades without any changes or incidents. "Manufacturers think twice about taking on the expense of re-certification," says Yvonne Glienke, "especially when it comes to products for rare indications with correspondingly small quantities."
Prof. Dr. Oliver Muensterer, Head of the Children's Surgery Clinic and Polyclinic at the Dr. from Hauner Children's Hospital in Munich, knows such cases. "Until recently, we had a whole arsenal of different sized instruments for pediatric surgery from one manufacturer," he reports. All of a sudden only one standard size was available. The trend is towards products that can be used in both pediatric and adult settings. a half
