The medical device and diagnostics provider PHC has received European Union Medical Device Regulation RDM-EU certification for its APP-1000 motorized drug injection device. The device simplifies the administration of tumor necrosis factor (TNF) inhibitors, anti-inflammatory drugs used in the treatment of rheumatoid arthritis, among other conditions. Manufactured in Japan, the APP-1000 allows patients to self-inject the product by pressing a button. Equipped with an LCD screen on which instructions for use are displayed, the device saves the injection history, which can then be transferred to a smartphone and thus checked by the prescriber.
Taking effect in May 2021, the RDM-EU certification replaces the Medical Device Directive (MDD) and the Active Implantable Medical Device Directive (AIMD). The new certification aims to improve the safety and quality of medical devices, but also to protect public health and patient safety. The certification now allows PHC to distribute the APP-1000 in the European Union, Switzerland and South America.