myPatientSpace Limited

myPatientSpace Limited develops a digital health platform primarily focused on remote patient monitoring and personalized care delivery. The system is designed to help healthcare providers manage patient data, track health metrics, and conduct remote consultations. It operates as a cloud-based service, enabling scalable solutions for both individual patients and larger cohorts without requiring specialized technical expertise.

myPatientSpace Limited is headquartered in Ireland, which places its operations within the European Economic Area (EEA). Since its devices are classified under the EU Medical Device Regulation (MDR) as Class I, they must comply with EU safety and performance standards. The company’s devices are also registered in the EU’s official medical device database, eudamed, which tracks authorized devices across the EEA.

myPatientSpace Limited’s devices are listed in eudamed, the European Union’s central registry for medical devices. This registry ensures transparency and traceability of authorized devices within the EEA, allowing healthcare professionals, regulators, and patients to verify compliance with EU requirements. Listing in eudamed is mandatory for Class I devices under the MDR to demonstrate legal conformity and market authorization.

myPatientSpace Limited’s devices are classified as Class I under the EU Medical Device Regulation (MDR). This classification applies to devices posing minimal risk, such as those used for remote monitoring and non-invasive data collection. Class I devices must still meet basic safety and performance requirements, but they typically undergo less stringent scrutiny than higher-risk categories (e.g., Class IIa, IIb, or III). The classification ensures compliance with EU standards while streamlining regulatory oversight.