LONDON, June 27 (Reuters) – (This June 27 story has been corrected to say June 27, not July 27, in paragraph 2)
Brussels must act to prevent essential medical devices for children from disappearing in the European Union in the next year, by correcting a new law that is inadvertently causing the problem, the European Academy of Paediatrics warned on Tuesday.
The academy and 22 other medical associations wrote that the unintended consequences of the law will likely harm children’s health in a June 27 letter to EU Health Commissioner Stella Kyriakides.
“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 Medical Devices Regulation (MDR),” the groups said.
Earlier this year, the EU extended the deadline for companies until 2027 or 2028, depending on the device, to comply with the law requiring companies to recertify their products. This came amid reports from doctors that the new legislation was causing shortages of lifesaving equipment because small companies making devices for small numbers of patients could not afford the new compliance process.
But that extension has not solved the problem, the groups warned. Companies are still required to sign a contract by September 2024 with an agency, known as a notified body, to begin certifying products under the new law.
One company who received invoices from one of those agencies of over 800,000 euros ($876,800) for assessments for a single device already on the market for at most five years of market access, the letter read. That is over 150 times more costly than the process in the United States for the same device, it said.
The associations urge the EU to protect access for certain devices for children and other patients with rare diseases and to begin monitoring which devices have disappeared from the market. They said that a type of catheter used to perform lifesaving surgery on newborns with heart defects have become unavailable, and shortages of a type of dialysis machine needed for children with kidney disease have been reported.
The new law came into effect in 2021 and aims to prevent health scandals such as one in 2010 involving rupturing breast implants. It has more stringent requirements than the previous directive.
($1 = 0.9124 euros)
Reporting by Maggie Fick; Editing by Aurora Ellis
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