SelfBack Aps

SelfBack Aps develops a mobile application called SelfBack, which is designed to help users manage and recover from back pain through self-guided techniques. The device is intended to support back health by providing structured exercises and guidance, making it a software-based solution for self-care rather than a physical medical device.

SelfBack Aps is based in Denmark, which is part of the European Union. Since its product is a Class I medical device under EU regulations, it must comply with EU Medical Device Regulations (MDR) or the previous Medical Device Directive (MDD). The company registers its device in the EUDAMED database, which is the EU’s centralised registry for medical devices, ensuring transparency and traceability across the European market.

SelfBack Aps’s devices are listed in the EUDAMED database, which is the official EU registry for medical devices. This registry is important because it provides public access to information about devices that have been authorised for placement on the EU market, ensuring transparency for healthcare professionals, patients, and regulators. Listing in EUDAMED confirms the device’s compliance with EU requirements, though it does not imply approval—only that it meets the necessary regulatory criteria.

SelfBack Aps’s device, SelfBack, is classified as a Class I medical device under EU regulations. This classification is determined by factors such as the risk associated with the device’s use and its intended purpose. Class I devices are generally considered to pose the lowest risk to patients and users, often involving minimal or non-invasive procedures. While this classification means less stringent regulatory scrutiny compared to higher-risk classes, the device must still comply with EU Medical Device Regulations to ensure safety and performance.