The study identified over 1600 records from Embase and Pubmed out of which, according to the research protocol, 99 trials and 104 reports were scrutinised. The results showed that paediatric devices require specific consideration and have unique barriers for development that should be taken into consideration by regulators.
Prof. Dr. Marc Gewillig presented the issue of availability of paediatric devices in the context of the implementation of the medical device regulation.
He notably gave significant examples of devices that were no longer available albeit essential for patient care. He also pointed to the high increase of costs to get paediatric devices reach the market, compared to the US pricing.
Prof. Dr. Berthold Koletzko voiced the paediatric clinicians concerns and challenges as the implementation of the Medical Device Regulation is occurring. He notably called for the creation of an expert panel on Paediatric Devices as a mean to take concrete steps towards the consideration of children's needs.
Ms. Rachel Neubrander from the Food and Drug Administration provided insight on how the FDA handled paediatric devices.