Cardiologists fear new regulations will cause a medical device shortage in Europe
Concerns are growing in Europe that a shortage of essential medical devices used to treat cardiovascular patients is approaching—or that it may already be underway. Diagnostic catheters, ablation catheters and stents are just some of the solutions cardiologists on the continent are now struggling to obtain.
The European Society of Cardiology (ESC) shared these concerns in a recent statement, emphasizing that a shortage of these devices will result in “dire consequences for the diagnosis and treatment” of cardiovascular disease, especially among high-risk patients and children.
If this issue is not addressed before the upcoming Medical Device Regulation (MDR) certification deadline—scheduled for May 26, 2024—ESC representatives fear an already troubling situation could get much worse. The MDR is an updated set of regulations associated with the manufacturing and distribution of medical devices in Europe. It went into effect in May 2021.
The ESC called for an extension of the MDR certification deadline as stakeholders work to prepare for the changed regulations.
“During this additional period, notified bodies should be given extra capacity to process recertification applications, while manufacturers would have more time to adjust to the regulations and cope with supply chain problems,” according to the ESC statement. “The ESC also asks regulators to explore the opportunity for joint procurement actions to counteract shortages. In addition, the ESC encourages the adoption of specific regulatory provisions to support the development and certification of orphan devices and it supports the possibility of conditional approval pathways.”
The ESC and Biomedical Alliance in Europe developed a survey of different European healthcare organizations to examine this issue. Forty-one percent of responses came from ESC members. Overall, 49% of ESC respondents have experienced issues with medical device availability since the MDR was put into place. The device in question was intended for a pediatric patient in 30% of the cases where availability was an issue. Also, in 42% of those cases ultimately involved an alternative device that “was not as effective” as the device the physician wanted to use.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.