Clasificación de Dispositivos Médicos 2017/745

Classification of Medical Devices Under Regulation 2017/745

• Regulation (EU) 2017/745 establishes a classification system for medical devices, ensuring safety and efficacy standards based on inherent risk.
• The system categorizes devices from low (Class I) to high risk (Class III). This classification impacts regulatory demands and conformity assessment procedures.
• Devices are categorized considering intended use, purpose, and foreseeable risks, influencing regulatory oversight.

Class I Devices

• Present a low risk to patient health.
• Have minimal regulatory burden, often requiring only conformity assessment documentation.
• Examples: Certain bandages, some simple surgical instruments, and some catheters.

Class IIa Devices

• Moderate risk devices.
• Require more scrutiny in manufacturing processes and documented performance than Class I devices.
• Manufacturers must demonstrate efficacy and safety.
• Examples include: Many diagnostic devices, some infusion devices, and dressings with specific functions or materials.

Class IIb Devices

• Higher risk than Class IIa devices.
• Demand thorough technical documentation and rigorous testing.
• Subject to substantial regulatory oversight for validating performance and safety.
• Examples: Certain surgical instruments, some cardiovascular devices, and certain implants.

Class III Devices

• Highest risk devices, posing significant patient safety concerns.
• Require extensive validation, stringent conformity requirements, and often extensive clinical trials to demonstrate long-term efficacy and safety.
• Examples: Life-sustaining implantable devices like pacemakers, certain artificial heart valves, and advanced cardiovascular devices.

Essential Requirements

• All devices, regardless of class, must meet fundamental safety and performance requirements.
• The requirements cover design, manufacturing, risk management, labeling, and conformity assessment.

Conformity Assessment

• Procedures and tests to demonstrate compliance with the regulation.
• Documentation and process vary based on the device's classification.

Implications for Manufacturers

• Device classification significantly influences time, expense, and resources for development, manufacturing, and market authorization.
• Manufacturers face varying regulatory burdens depending on the device's risk classification.
• Accurate classification is crucial for successful navigation of regulatory obligations, as misclassification can delay approval and increase costs.

Conclusion Regarding Risk Categorization

• The classification system strategically categorizes devices based on inherent risk, leading to a tiered approach to regulatory requirements.
• This approach aligns regulatory oversight with potential patient risks, promoting safety and efficacy in healthcare.