Last month, the European Academy of Paediatrics and 22 other medical associations wrote a letter to the EU Health Commissioner, urging the correction of the new EU Medical Devices Regulation (MDR). They warned that the regulation has led to a shortage of medical devices for children and those with rare diseases. The academy underscored the urgency of the problem, saying that, “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.” The Academy underscored the severity of the problem, noting that a catheter needed for life-saving operations for children and patients with rare diseases has already disappeared from the market.
Medical device shortage
The shortages are a result of several factors, including the scarcity of notified bodies to certify medical devices and the inability of many smaller medical device manufacturers to afford costs associated with the new compliance process. The increased costs may be, in part, a result of the lack of notified bodies available to certify devices. Despite an extension to the deadline for manufacturers to comply with MDR, costs to certify or recertify products are still disproportionately high. One company attempting to recertify a product said it had to pay 800,000 euros, more than 150 times the cost of the equivalent U.S. process for the same device.
Regulatory trends
By contrast, the introduction of regulations or non-binding guidelines specific to products marketed for children has been an ongoing focus of U.S. regulators and lawmakers. Recent regulatory activity includes safety warnings by the U.S. Food and Drug Administration (FDA) and the U.S. Consumer Product Safety Commission (CPSC) regarding neck floats marketed for infants and toddlers. The National Highway Traffic Safety Administration (NHTSA) also recently added new testing requirements for child safety seats.
These regulations make it clear that the United States is prioritising providing specific protections for children. Considering the increased pressure from groups like the European Academy of Paediatrics and the growing regulatory trend to provide additional safety protections for children, the EU may follow suit with specific regulations for medical devices marketed for children.
The EU does have existing regulations governing other industries that are aimed specifically at protecting children. Article 8 of the General Data Protection Regulation (GDPR) outlines specific protections for the data of children 16 and under. Article 8 states that, “where the child is below the age of 16 years, such processing shall be lawful only if and to the extent that consent is given or authorised by the holder of parental responsibility over the child.” Following the UK’s example, the EU also recently announced it would explore the creation and implementation of an Age Appropriate Design Code, further evidence of the EU’s child-specific regulation of the technology industry.
Recommendations for companies
As medical device manufacturers in the EU work to comply with MDR, and as industry associations call for additional rules, companies should take additional steps to ensure they fully understand their regulatory obligations. Changes to regulations also means the potential for new compliance processes and an increased risk for product recall.
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