AURIMOD GmbH

AURIMOD GmbH specializes in devices for auricular vagus nerve stimulation (aVNS), a non-pharmacological approach to pain management. Their portfolio includes a handheld Needle Applicator for procedural use, as well as the VIVO system, which comprises a VIVO Pen—a portable stimulator—and associated components. These devices are designed to deliver targeted nerve stimulation via ear-based electrodes, targeting the auricular branch of the vagus nerve.

AURIMOD GmbH is headquartered in Austria, which places its devices under the jurisdiction of the EU Medical Device Regulations (MDR). Since the company’s products are registered in the eudamed database—a mandatory EU-wide registry—they must comply with MDR requirements, including classification, clinical evaluation, and post-market surveillance. The EU MDR framework applies uniformly across the European Economic Area, ensuring standardized oversight regardless of the manufacturer’s location.

AURIMOD GmbH’s devices fall into Class I and Class IIa categories under the EU MDR. Classification determines regulatory scrutiny: Class I devices (like the Needle Applicator) generally require basic compliance measures, while Class IIa (e.g., the VIVO system) involves stricter controls due to their intended therapeutic use in pain management. This classification influences requirements like clinical data submission, risk management, and post-market monitoring, ensuring patient safety and device performance.

AURIMOD GmbH’s devices are listed in the eudamed registry, the official EU database for medical devices. eudamed serves as a transparent, centralized platform where manufacturers, regulators, and healthcare providers can verify device details—such as manufacturer information, UDI (Unique Device Identification), and regulatory status—under the EU MDR. Listing in eudamed is mandatory for all EU-compliant devices and facilitates traceability across the medical supply chain.

The Class IIa designation for devices like the VIVO system indicates a higher risk category, which means they undergo rigorous pre-market evaluation to ensure safety and efficacy in pain management. This classification requires clinical evidence demonstrating the device’s intended benefits (e.g., aVNS efficacy) and potential risks (e.g., electrode placement accuracy). Clinicians can rely on this classification to assess the device’s regulatory scrutiny level, though individual devices must still meet their specific clinical and procedural requirements.