TY - JOUR T1 - Medical devices that look like medicines: safety and regulatory concerns for children in Europe JF - Archives of Disease in Childhood JO - Arch Dis Child SP - 147 LP - 154 DO - 10.1136/archdischild-2018-316391 VL - 105 IS - 2 AU - Suzy Huijghebaert AU - Pauline De Bruyne AU - Karel Allegaert AU - Saskia Vande Velde AU - Ruth De Bruyne AU - Stephanie Van Biervliet AU - Myriam Van Winckel Y1 - 2020/02/01 UR - http://adc.bmj.com/content/105/2/147.abstract N2 - Introduction Medical devices (MedDevs) and medicines are assessed (and monitored) differently before and after launch. There are products for repeated oral ingestion that are marketed in the European Union as MedDevs.Objectives and methods To illustrate the consequences of these differences in assessment, we compared the leaflet information of three MedDevs with the standards for medicines and with published evidence at launch. As examples, gelatin tannate (GT), its combination with tyndalised probiotics (TP) (GTTP) for diarrhoea and a gel containing hyaluronic acid (HA)/chondroitin sulfate (CS)/poloxamer (Pol407) (HACSPol) for gastro-oesophageal reflux disease were examined.Results Applying standards for medicines, product composition is insufficiently defined in the MedDev leaflet (eg, plant origin, polymerisation grade, dose and ratio of the relevant constituents). As no age limit is mentioned in the leaflets, all 3 products allow use in children from birth onwards, although published clinical documentation in children was poor (GT) or lacking (GTTP and HACSPol). MedDev leaflets do not mention adverse events (AEs), while literature search suggests safety concerns such as tannic acid (TA) cytotoxicity, potentially more diarrhoea/AEs with TP, use of doses higher than established safe (TA and HA) and lack of chronic toxicity studies for oral Pol407. None refers to interactions with medicines, although some ingredients may affect medicine absorption.Conclusion Although these MedDevs require repeated oral intake as do medicines, their assessment and monitoring differ significantly from the standards for medicines. Compared with medicines, MedDevs for repeated oral use are poorly labelled and rely on very limited clinical information at market release. ER -