Class I vs. Class IIa: Understanding the Distinction

• Class I devices are typically self-certified, meaning the manufacturer assesses compliance internally without requiring external validation.
• Class IIa devices, like UpHill’s software, undergo a rigorous audit by an independent Notified Body - a recognized regulatory entity responsible for ensuring compliance with EU medical device laws. This process includes detailed assessments of design, functionality, risk management, and clinical effectiveness.

2. Complexity and Clinical Impact of Software Features

• Class I medical devices are often limited to basic monitoring or administrative functions.
• Class IIa devices perform more clinically significant tasks, such as decision support, care coordination, and automation of clinical workflows. Because they influence patient outcomes, these devices require robust validation, risk assessment, and regulatory oversight.

3. Confidence in Results and Processes

• Class I software may collect and display patient data, but without an external audit, its accuracy and reliability are not independently verified.
• Class IIa software must demonstrate clinical accuracy, reliability, and safety, providing evidence-based decision support and automated workflows that directly impact patient care. UpHill’s certification ensures higher confidence in the system’s outputs and recommendations.

4. Risk Management Requirements

• Class I software follows basic risk management protocols but does not require a structured risk assessment.
• Class IIa software must comply with ISO 14971, the international standard for medical device risk management. This includes continuous monitoring, risk mitigation strategies, and formal documentation of potential hazards.

5. Post-Market Surveillance & Compliance

• Class I devices require general monitoring, but no structured post-market surveillance (PMS) plan.
• Class IIa software demands continuous data collection, safety reporting, and regulatory compliance updates. This ensures long-term safety and effectiveness even after deployment in real-world settings.

6. Clinical Validation & Evidence Requirements

• Class I software typically does not require extensive clinical validation.
• Class IIa certification mandates scientific evidence, usability studies, and performance evaluations to validate the software’s clinical impact.

7. Software Updates & Change Control

• Class I devices can undergo software updates without needing regulatory approval unless a significant change is made.
• Class IIa software updates must be validated and, in some cases, reviewed by regulatory authorities if they affect clinical functionality.

8. User Documentation & Safety Information

• Class I software has minimal documentation requirements.
• Class IIa software requires comprehensive technical documentation, including detailed user manuals, risk disclosures, and clinical usage guidelines.

What Does This Certification Mean for Hospitals?

1. Compliance with the Highest Regulatory Standards
   Full confidence that the solution has been evaluated according to objective, internationally recognized standards.
2. Reduced Legal and Regulatory Risks
   Lower exposure to compliance issues and potential failures that could compromise patient safety or lead to legal implications for the institution.
3. Greater Safety and Reliability in Clinical Decision-Making and Care Automation
   UpHill directly impacts the patient journey by streamlining processes and supporting doctors and nurses in clinical decision-making.

A Step Forward for Care Automation