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Medical Device Product Classification

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Medical Device Product Classification

Purpose of medical device classification

Medical device classification is a system that categorizes devices based on their intended use and inherent risk. This system guides the level of regulatory control needed to ensure their safety and effectiveness.

  • Risk-based approach: Classifying devices based on risk guides the level of regulatory scrutiny needed. Higher-risk devices require more stringent controls to ensure safety and efficacy.
  • Premarket requirements: Determines the level of premarket evaluation (e.g., testing, data submission) required for device approval.
  • Market access: Influences the ease and speed of bringing a device to market.
  • Transparency: Classification of medical devices helps manufacturers understand their regulatory obligations and provides transparency for patients and healthcare providers.

Device Categories

• Invasive and Active Devices

  1.  Active Devices: Use an energy source (e.g., electrical, mechanical) to diagnose or treat a medical condition. 
  2. Inactive Devices: Do not use an energy source and primarily aid in diagnosis or monitoring.

• Based on Sterility

  1.  Sterile Devices: Are free from microorganisms and intended for use in sterile environments. 
  2. Non-Sterile Devices: Do not require sterility and may come into contact with non-sterile environments.

• Based on Invasiveness

  1.  Implantable Devices: Are placed inside the body for a period of time. 
  2. Non-Implantable Devices: Are used externally on the body or come into temporary contact with it.

• Based on Duration of use

  1. Transient Use: Intended for continuous use for less than 60 minutes. 
  2. Short-Term Use Devices: Intended for continuous use between 60 minutes and 30 days. 
  3. Long-Term Use Devices: Intended for use for more than 30 days.

Factors Influencing Classification

  1. Intended use: The device’s purpose and its impact on the human body.
  2. Duration of contact with the body: Longer contact duration often implies higher risk.
  3. Degree of invasiveness: More invasive procedures pose greater risks.
  4. Potential for harm: Devices with the potential for serious injury or death are classified as higher risk.
  5. Novelty: New, untested devices usually require more stringent classification.

Importance of accurate classification

 

  1.  Correct regulatory oversight: Ensures appropriate level of scrutiny for safety and effectiveness.
  2. Efficient development and market access: Faster approval for lower-risk devices.
  3. Post-market surveillance: Higher-risk devices undergo stricter monitoring for adverse events.

Classification Systems

  1. Global variations: Different countries and regions have their own classification systems, though they share common principles.
  2. US FDA: Classifies devices into Class I (low risk), Class II (moderate risk), and Class III (high risk).
  3. EU MDR: Classifies devices into Class I (low risk), Class IIa (medium risk), Class IIb (high-medium risk), and Class III (high risk).

To understand more about specific country regulations and classification please follow link below :

European Medical device Classification
US FDA Medical device Classification
India CDSCO Medical device Classification
GHTF Medical device Classification
Saudi SFDA Medical device Classification
South Korea MSDF medical device Classification
Australia TGA Medical device Classification