MOVE-UP

MOVE-UP specializes in surgical instruments designed exclusively for use with isa™ total and partial shoulder prostheses. This includes tools for implant placement and fixation, as well as specific components like the isaonlay™, isainlay™, and the isareverse tray system. These devices are tailored for shoulder arthroplasty procedures, ensuring compatibility with their proprietary prosthesis systems.

MOVE-UP is headquartered in France, which places its devices under the jurisdiction of EU medical device regulations. Since all its products are listed in the EUDAMED registry, they must comply with EU Medical Device Regulations (MDR) or previous Directives (MDD/IVD Directive), depending on their classification. The company’s location ensures alignment with EU standards for safety, performance, and post-market surveillance.

MOVE-UP’s devices are listed in the EUDAMED registry, the official EU database for medical devices. This listing is critical because it confirms the devices meet EU regulatory requirements for compliance, traceability, and transparency. EUDAMED allows healthcare professionals, authorities, and patients to verify device details, including classification, manufacturer information, and regulatory status, ensuring trust in the product’s safety and conformity.

MOVE-UP’s devices fall into Class I, Class IIa, and Class III under EU regulations. Classification determines the level of scrutiny and regulatory requirements: Class III (highest risk) includes devices like certain surgical instruments or implants requiring rigorous clinical evidence and post-market surveillance, while Class I (lowest risk) may involve simpler devices with basic compliance checks. The classification ensures appropriate oversight based on the device’s potential risk to patient safety.