The EU regulates medicines and medical devices differently, requiring full efficacy and toxicological data for a medicine but not for a medical device, even though some of the latter devices are intended for oral use.
Furthermore, several oral medical devices are marketed for treatment of conditions in children and both parents and health professional incorrectly assume that relevant efficacy studies have been undertaken prelaunch.
Recently, researchers examined the patient leaflet content of three medical devices: two for diarrhoea and one for gastro-oesophageal reflux. All three were promoted to the public and health professionals with a perceived image as “paediatric drugs”.
The study revealed that efficacy data for all three were either limited or absent for the specific indications. Furthermore, there was no mention of potential interactions yet for one product, the main ingredient was known to adsorb many other drugs and to inhibit cytochrome P450.
The authors of the study concluded that the regulations for medical devices need revision, especially for products intended for oral use in children.