European Classification and Risk of Medical Devices

Study Notes

Medical devices are classified into four risk classes based on the level of risk associated with their use:
- Class I: Low risk, e.g., bandages, examination gloves
- Class IIa: Low-moderate risk, e.g., contact lenses, hearing aids
- Class IIb: Moderate-high risk, e.g., ventilators, infusion pumps
- Class III: High risk, e.g., implantable devices, pacemakers

Medical devices must comply with relevant harmonized standards, such as:
- EN ISO 13485:2016 (Quality Management System for Medical Devices)
- EN ISO 14971:2012 (Risk Management for Medical Devices)
- EN 62304:2006 (Software Life-Cycle Processes for Medical Devices)

A QMS is a set of policies, procedures, and processes to ensure the quality of medical devices:
- Includes design, development, production, installation, and servicing
- Ensures compliance with regulatory requirements and standards
- Continuously monitors and improves the quality of medical devices

Medical devices are classified into four risk classes based on the level of risk associated with their use
Class I: Low risk, includes devices such as bandages and examination gloves
Class IIa: Low-moderate risk, includes devices such as contact lenses and hearing aids
Class IIb: Moderate-high risk, includes devices such as ventilators and infusion pumps
Class III: High risk, includes devices such as implantable devices and pacemakers

Medical devices must comply with relevant harmonized standards
Examples of harmonized standards include EN ISO 13485:2016, EN ISO 14971:2012, and EN 62304:2006
EN ISO 13485:2016 sets out requirements for a Quality Management System (QMS) for medical devices
EN ISO 14971:2012 sets out requirements for risk management for medical devices
EN 62304:2006 sets out requirements for software life-cycle processes for medical devices

A QMS is a set of policies, procedures, and processes to ensure the quality of medical devices
A QMS includes design, development, production, installation, and servicing
A QMS ensures compliance with regulatory requirements and standards
A QMS continuously monitors and improves the quality of medical devices

Risk management is a systematic process to identify, evaluate, and mitigate risks associated with medical devices
Risk management involves risk analysis, risk evaluation, risk control, risk monitoring, and risk review
Risk analysis identifies potential hazards and estimates their risk
Risk evaluation determines the level of risk and prioritizes mitigation efforts
Risk control implements measures to mitigate or eliminate risks
Risk monitoring continuously monitors and updates the risk management process
Risk review periodically reviews the risk management process to ensure its effectiveness