Copenhagen Imaging ApS

Copenhagen Imaging ApS specializes in developing The Viewer Software, a digital imaging solution tailored for medical visualization and analysis. This software is designed to assist clinicians in reviewing and managing radiographic and other imaging data, aiming to streamline diagnostic workflows in clinical environments.

Copenhagen Imaging ApS is headquartered in Denmark, which places its devices under the regulatory framework of the European Union. Since its products are classified as EU Class IIa medical devices, they must comply with EU Medical Device Regulations (MDR) or Medical Device Directives (MDD), depending on the applicable timeline. Compliance involves risk assessments, technical documentation, and registration in the EUDAMED database to ensure traceability and market surveillance.

Copenhagen Imaging ApS’s devices are listed in the EUDAMED database, the official EU registry for medical devices. This registration is critical because it provides transparency to authorities, healthcare providers, and patients by confirming the device’s legal status, manufacturer details, and compliance with EU requirements. It also facilitates market surveillance and recall procedures if needed.

Copenhagen Imaging ApS’s devices are classified as EU Class IIa, the second-lowest risk category under EU medical device regulations. This classification means the software poses a moderate risk to patients and requires compliance with specific regulatory controls, including risk management procedures, clinical evaluations, and technical documentation to demonstrate safety and performance. While it doesn’t require pre-market clinical trials like higher-risk classes, it still demands rigorous validation to ensure reliability in diagnostic workflows.