The European Academy of Paediatrics (EAP) has warned urgent action is needed “to secure continued access to essential medical devices for children and for patients with orphan diseases.”
In a letter to Stella Kyriakides, the European Commissioner for Health and Food Safety, leaders at EAP and other pediatric bodies outlined how the Medical Device Regulation (MDR) is affecting the availability of products that target small patient populations. Because MDR has “hugely” increased time and cost burdens on industry, manufacturers are withdrawing devices sold in smaller numbers.
The letter cites the removal from the market of balloons used in a life-saving maneuver and reports of shortages of dialysis machines used in young children. The pediatricians said the new MDR timelines “will not halt the disappearance of essential medical devices from the EU market.”
To correct the problem, EPA and its coauthors want the EU to create pediatric and orphan device statuses that are eligible for “a simplified, fast and low-cost” conformity assessment. The pediatricians cited the United States’ Humanitarian Device Exemption regulation as an example…