As the EU’s new system for regulating medical devices takes effect, some medtech companies are finding the process of securing new authorizations for their previously authorized devices overwhelming—and, in some cases, not worth the trouble.
Getinge is among the handful of devicemakers that told Reuters they’ve opted to remove certain products from the European market rather than face the higher costs and longer wait times of the new regulatory process, according to a report this week. That will leave hospitals on the continent unable to access devices and tools that may have been in regular use for decades.
Mikael Johansson, the Getinge executive heading up implementation of the new Medical Device Regulation, known as MDR, told the outlet that the Swedish company has had to cut about a third of the products in its portfolio from EU sales. The process of recertifying the rest, meanwhile, began in 2018 and is still only about 20% complete, Johansson reported.
Germany’s AndraTec, meanwhile, was selling six of its stents and catheters in the EU under the previous regulation. About half of those will now be eliminated, CEO Andreas Kohl told Reuters, thanks to the prohibitively high costs of reapplying for clearance of each of the devices.
Osypka, German maker of temporary pacemakers for newborns and other patients in need of cardiac support, has also been boxed out by the costs of securing approvals for already-approved devices. It has taken five of its products off the market.
“These types of products are totally beneficial for these patients, but we cannot afford the half a million euros it takes to conduct a clinical study, even though these products have been on the market for 30 or 40 years,” CEO Nicola Osypka told the news outlet.
Osypka added that her company will also not be able to shell out the approximately 1 million euros it would need to submit an MDR application for a new product that took eight years to develop and has already undergone clinical trials.
According to Reuters, the costs of certification are now up to 10 times higher than they were under the EU’s previous regulations, and it can take more than two years to secure clearance, compared to a timeline of just a few months before MDR. The EU Commission stated it was “concerned” about that pace and was working to ensure patients and doctors will have access to needed devices.
The commission also admitted in a statement that it hasn’t yet authorized enough agencies across Europe to adequately move through the mountain of recertification applications. Three dozen of these notified bodies have been approved, and another 20 are under consideration; under the old system, nearly 100 agencies were sharing the workload, according to Reuters.
MDR was introduced in 2017 and took effect in 2021, when devicemakers were given a three-year grace period to comply with the new regulations. Amid the chaos of the implementation, however, the EU’s health commissioner earlier this month proposed an extension to that transition time.
In a Dec. 9 speech, Commissioner Stella Kyriakides acknowledged that “the transition to the new rules has been slower than we anticipated,” citing the pandemic, supply chain shortages caused by the Russian war in Ukraine and the low number of notified bodies.
“We are facing a risk of shortages of life-saving medical devices for patients. This is a risk we cannot take,” she said.
To mitigate that risk, Kyriakides proposed extensions that would give high-risk devices until 2027 to comply with MDR, while medium- and low-risk products can stay valid under the previous regulations until 2028. The proposal will be submitted as an amendment to the law that enacted MDR early next year, when it will be voted on by the European Council and Parliament.