CE accreditation and barriers to CE marking of paediatric drug calculators for mobile devices: a scoping review and qualitative analysis

Background: Paediatric drug calculators (PDCs) intended for clinical use qualify as medical devices under the Medical Device Directive and the Medical Device Regulation. The extent to which they comply with European standards on quality and safety is unknown. Objective: Determine the number of PDCs available as mobile applications for use in the Netherlands that bear a CE mark and explore the factors influencing the CE marking of such devices among application developers. Methods: A scoping review of the Google Play and App stores was conducted to identify PDCs available for download in the Ne... Mehr ...