EU Medical Devices Regulation causes unintended disappearances of medical devices for children, doctors state

Doctor groups and associations have appealed to the EU to correct the EU Medical Devices Regulation law that may cause unintended shortages of essential drug and medical devices for children and rare disease patients.

In a letter sent on June 27, 2023 to EU Health Commissioner Stella Kyriakides, the Academy, along with 22 other medical associations, cited that the law that requires companies to recertify their products. Though the deadline for companies to achieve this has been extended until 2027/2028, reports from doctors claim that the new legislation has caused shortages of certain lifesaving equipment, especially those from small drug device companies that cannot afford the new compliance procedure, and that the extension has not solved the issue for these companies. All drug device companies are required by the new law to sign a contract by September 2024 with a notified body to begin the recertification process. The law came into effect in 2021 with the goal of preventing health scandals. 

The group cited one particular company that received invoices from a notified body of over EUR €800,000 for a single device to be assessed. The device is already on the market for, at the most, 5 years of market access. At nearly 150 times more costly than the process in the United States for the same device, the group warns that similar situations may cause lifesaving drug devices to disappear from the market. In the letter, the associated groups urged for access protection of certain drug devices for children and patients with rare diseases. They reported that a specific type of catheter utilised in lifesaving surgery on newborns with heart defects has become unavailable due to the law, as well as shortages in dialysis machines for children with kidney disease. 

The group emphasised the dire consequences of such shortages in their letter, stating “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 [the] disappearance of devices due to unforeseen effects of the EU Medical Devices Regulation.” 

Source: EU must prevent medical devices for children from disappearing, say doctors groups [Accessed June 28, 2023] https://www.reuters.com/business/healthcare-pharmaceuticals/eu-must-prevent-medical-devices-children-disappearing-say-doctors-groups-2023-06-27/