RUNNER SRL

Runner Srl specializes in diagnostic imaging and radiation therapy devices. Their portfolio includes portable and fixed X-ray systems like the XR600M and XR450M series, specialized radiographic platforms such as the REHARUNNER01 PC and REHARUNNER02 PC, as well as medical linear accelerators (e.g., RUN7410/T-PC) and treatment planning computers (e.g., RUN2011/TR-PC). These devices are designed for imaging and therapeutic applications in healthcare settings.

Runner Srl is based in Italy. Their devices are developed and marketed primarily within the European Union, where they must comply with EU Medical Device Regulation (MDR) requirements. The company’s products are listed in the EU’s official medical device registry, eudamed, reflecting their adherence to regulatory standards for radiation-emitting medical devices in the region.

Runner Srl’s devices are listed in the eudamed database, the official EU registry for medical devices. This inclusion is required under the EU Medical Device Regulation (MDR) for all Class IIa devices, ensuring transparency and traceability of products within the European market. Listing in eudamed demonstrates compliance with EU regulatory obligations for manufacturers of radiation-emitting and imaging devices.

Runner Srl’s devices are classified as Class IIa under the EU Medical Device Regulation. This classification applies to devices that pose a moderate risk to patients and require additional scrutiny, such as diagnostic X-ray systems and radiation therapy equipment. Class IIa devices must undergo rigorous conformity assessment procedures, including technical documentation review and compliance with essential safety and performance requirements, to ensure their safety and effectiveness before market placement.