Buddy Healthcare Receives EU MDR Class IIa Compliance for its Care Coordination Platform

Helsinki, Finland -  June 18, 2025,  Buddy Healthcare, a leading provider of digital care coordination solutions, is proud to announce that its Platform has been audited to confirm compliance with Medical Device Regulation (MDR 2017/745) as a Class IIa medical device. The compliance, granted by SGS Fimko Oy (Notified Body 0598), marks a significant regulatory and operational milestone for the company and its customer base. 

Transitioning from a Class I device under the Medical Device Directive (MDD) to a Class IIa device under the Medical Devices Regulation (MDR), the platform now meets the European Union’s heightened standards for safety, performance, clinical evaluation, and traceability. This demonstrates Buddy Healthcare’s continued commitment to regulatory excellence and its readiness to meet evolving healthcare demands.

With this updated compliance, Buddy Healthcare is empowered to expand the platform’s medical functionalities, such as enhanced patient monitoring, advanced triage alerting, patient prioritisation, and patient-specific labels delivered in real time to clinical teams. These features support proactive care models, contributing to better outcomes and reduced burden on healthcare staff.

Jussi Määttä, CEO of Buddy Healthcare, commented, “Achieving this MDR compliance is a proud moment for Buddy Healthcare and a testament to our continued commitment to safe, clinically validated, and compliant care coordination.

This allows us to enhance our platform further with advanced medical functionalities that support more proactive, efficient workflows for clinical teams and ultimately lead to better patient outcomes.

• ISO 13485:2016 – Medical Devices Quality Management Systems
• ISO 27001:2022 – Information Security Management, including annual penetration testing by an external certified firm
• Cyber Essentials Plus
• Web Content Accessibility Guidelines (WCAG) 2.2
• DCB0129 Clinical Risk Management
• The Organisation for the Review of Care and Health Apps (ORCHA) approval
  
  Buddy Healthcare and its care coordination platform are subject to regular, rigorous external audits to ensure continued compliance and excellence. These certifications reflect our deep commitment to safety, data protection, and delivering trusted digital health solutions to hospitals and healthcare systems.