Medical Devices and IVDs

Product Classification

Purpose of medical device Product classification

Medical device product 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

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

Based on Sterility

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

Based on Invasiveness

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

Based on Duration of Use

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

Factors Influencing Medical Device Product Classification

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

Importance of accurate Medical Device Product Classification

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

Classification Systems

Global variations: Different countries and regions have their own classification systems, though they share common principles.
US FDA: Classifies devices into Class I (low risk), Class II (moderate risk), and Class III (high risk).
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 medical device product classification, please follow the links 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

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