CE Accreditation and Barriers to CE Marking of Pediatric Drug Calculators for Mobile Devices: Scoping Review and Qualitative Analysis.

ABSTRACT:

Background

Pediatric 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

This study determines the number of PDCs available as mobile apps for use in the Netherlands that bear a CE mark, and explore the factors influencing the CE marking of such devices among app developers.

Methods

A scoping review of Google Play Store and Apple App Store was conducted to identify PDCs available for download in the Netherlands. CE accreditation of the sampled apps was determined by consulting the app landing pages on app stores, by screening the United Kingdom Medicines and Healthcare product

SUBMITTER: Koldeweij C 

PROVIDER: S-EPMC8713103 | biostudies-literature | 2021 Dec

REPOSITORIES: biostudies-literature