Peer-reviewed article
Medical devices that look like medicines: safety and regulatory concerns for children in Europe
Suzy Huijghebaert, Pauline De Bruyne, Karel Allegaert, Saskia Vande Velde, Ruth De Bruyne et al. ·
Summary
Written by AI, not yet AICS's view · claude-haiku-4-5-20251001This study compares how medical devices for repeated oral use in children are regulated and labelled in Europe compared to medicines, using three products (gelatin tannate, a probiotic combination, and a hyaluronic acid gel) as examples. The researchers found that medical devices have much weaker labelling requirements, lack information about side effects, do not specify age limits despite being given to newborns, and have little or no clinical evidence in children at the time they reach the market. Medical devices are approved through different processes than medicines, resulting in less safety information being available to parents and healthcare providers. The study highlights potential safety risks including insufficient product composition information, lack of adverse event reporting, and missing information about interactions with other medicines.
Key points
- Medical devices for repeated oral use lack adequate product composition information compared to standards for medicines (e.g., plant origin, dose, and ratios of constituents not specified)
- All three products examined allow use in children from birth onwards despite absent or very limited clinical documentation in children
- Medical device leaflets do not mention adverse events, while published evidence suggests safety concerns including cytotoxicity, gastrointestinal complications, and doses exceeding established safe levels
- No information is provided about potential interactions with medicines, although some ingredients may affect medicine absorption
- Medical devices undergo significantly different assessment and monitoring than medicines despite requiring repeated oral intake similar to medicines
Limitations
This is a document analysis comparing three specific products rather than a systematic review or epidemiological study, so it cannot quantify the prevalence of these labelling and safety issues across all medical devices in Europe. The study does not assess actual harm to children, only identifies potential safety concerns through regulatory comparison and literature review.
Abstract
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.