- New medical device regulations in Europe could result in a shortage of medical devices for children, the European Academy of Paediatrics and more than 20 other medical associations wrote in a June 27 letter to European Commissioner for Health and Food Safety Stella Kyriakides.
- Reports available to clinicians indicate a “high likelihood of losing significant numbers of essential medical devices,” the groups wrote. “This will result in an avoidable risk of death and serious injury, not as a consequence of unsafe medical devices, but as a consequence of disappearance of devices due to unforeseen effects of the EU MDR.”
- The cost of certification by notified bodies poses a barrier to manufacturers of devices that cater to small groups of patients, such as children or people with rare diseases, and could result in manufacturers withdrawing devices sold in smaller numbers from the EU market, they wrote.
European regulators voted earlier this year to extend the transition period for the Medical Devices Regulation (MDR) to 2027 or 2028, depending on a device’s risk category.
However, the deadline for submitting devices to certification organizations, known as notified bodies, is much sooner. Manufacturers need to submit applications to a notified body by May 2024 and have a contract in place by September 2024 to be able to market their devices.
The cost of this process “forms a critical financial barrier for manufacturers” to introduce, or re-introduce, devices in the EU market, the medical associations warned in a letter. For example, one company with a single device received invoices of 800,000 Euros for a conformity assessment, which would allow it to be on the market for five years, they wrote. By comparison, 510(k) clearance in the U.S. costs roughly 5,000 Euros.
Some types of devices are already facing shortages, the letter writers warned. Balloons used to treat certain congenital heart defects in newborn infants have become unavailable, and shortages have been reported for dialysis machines used to treat young children with end-stage kidney disease.
The groups suggested establishing an EU-wide system to monitor whether specific medical devices are about to disappear from the market and creating a status designation for “pediatric” or “orphan” devices that could result in faster and cheaper conformity assessments.
In the interim, the associations recommended automatically granting permission for continued use of high-risk pediatric or orphan medical devices that have been on the market for at least three years without reported problems.