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Understanding Medical Device Classification: A Guide Based on CDSCO MDR Rules 2017
SATORI ONE CLICK SOLUTION LLP
March 16, 2025
Medical Devices

In the world of healthcare, medical devices play a crucial role in diagnosing, treating, and managing various medical conditions. However, not all medical devices are created equal. Their classification, based on risk, intended use, and other factors, determines the level of regulatory scrutiny they must undergo before reaching the market. In India, the Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health and Family Welfare, has established the Medical Devices Rules (MDR) 2017 to ensure the safety, efficacy, and quality of medical devices.

This blog aims to provide a comprehensive overview of the parameters for classifying medical devices as per the CDSCO MDR 2017. Whether you're a manufacturer, healthcare professional, or simply someone interested in understanding how medical devices are regulated, this guide will help you gain valuable insights.

Basic Principles for Classification of Medical Devices

Before diving into the specific parameters, it’s essential to understand the foundational principles that govern the classification of medical devices under the CDSCO MDR 2017:

  1. Intended Purpose: The classification of a device is primarily based on its intended purpose as defined by the manufacturer.
  2. Combination with Other Devices: If a device is intended to be used with another device, each device is classified separately. Accessories are classified independently of the main device.
  3. Software: Software that drives or influences the use of a medical device is classified in the same category as the device itself.
  4. Critical Use: If a device is not intended for a specific part of the body, it is classified based on its most critical specified use.
  5. Strictest Rule Applies: If multiple classification rules apply to a device, the strictest rule resulting in the highest classification is applied.

Parameters for Classification of Medical Devices

The CDSCO MDR 2017 outlines specific parameters for classifying medical devices into four categories: Class A (low risk), Class B (low-moderate risk), Class C (moderate-high risk), and Class D (high risk). Below is a detailed breakdown of these parameters:

1. Non-Invasive Medical Devices

Non-invasive devices are those that do not penetrate the body. Their classification depends on their contact with the body and intended use.

  • Contact with Injured Skin:
    • Class A: Devices used as mechanical barriers, for compression, or absorption of exudates for wounds that have not breached the dermis.
    • Class B: Devices used for wounds that have breached the dermis or for managing the wound microenvironment.
    • Class C: Devices used for wounds that have breached the dermis and cannot heal by primary intention.
  • Channeling or Storing Substances:
    • Class A: Devices for channeling or storing body liquids, tissues, or gases for infusion or administration.
    • Class B: Devices connected to active medical devices (Class B, C, or D) or used for channeling blood, storing organs, or body tissues.
    • Class C: Blood bags without medicinal products.
  • Modifying Compositions of Substances:
    • Class C: Devices intended to modify the biological or chemical composition of blood or other body liquids.
    • Class B: Devices that modify substances through filtration, centrifugation, or gas/heat exchange.
  • Other Non-Invasive Devices:
    • Class A: Devices that do not come into contact with the body or only contact intact skin.

2. Invasive Medical Devices

Invasive devices penetrate the body, either through a body orifice or surgically. Their classification depends on the duration of use and the body part involved.

  • Transient Use (≤60 minutes):
    • Class A: Devices not connected to active medical devices or connected only to Class A devices.
    • Class B: Devices used on the external surface of the eyeball or absorbed by mucous membranes.
  • Short-Term Use (≤30 days):
    • Class B: Devices not connected to active medical devices or connected only to Class A devices.
    • Class A: Devices used in the oral cavity, ear canal, or nasal cavity, not absorbed by mucous membranes.
  • Long-Term Use (>30 days):
    • Class C: Devices not connected to active medical devices or connected only to Class A devices.
    • Class B: Devices used in the oral cavity, ear canal, or nasal cavity, not absorbed by mucous membranes.
  • Connection to Active Medical Devices:
    • Class B: Devices connected to active medical devices (Class B, C, or D), regardless of duration.

3. Surgically Invasive Medical Devices

Surgically invasive devices penetrate the body through surgical intervention. Their classification depends on the duration of use and the nature of the device.

  • Transient Use:
    • Class B: General classification.
    • Class A: Reusable surgical instruments.
    • Class C: Devices supplying ionizing radiation, having a biological effect, or used for hazardous administration of medicinal products.
    • Class D: Devices in direct contact with the central nervous system or central circulatory system.
  • Short-Term Use:
    • Class B: General classification.
    • Class C: Devices undergoing chemical changes in the body or used for hazardous administration of medicinal products.
    • Class D: Devices with biological effects, absorbed by the body, or in direct contact with the central nervous system or central circulatory system.
  • Long-Term Use and Implantable Devices:
    • Class C: General classification.
    • Class B: Devices placed into teeth.
    • Class D: Devices in direct contact with the heart, central circulatory system, or central nervous system; life-supporting devices; active devices; or devices undergoing chemical changes in the body.

4. Active Medical Devices

Active devices rely on a source of energy to function. Their classification depends on their intended use and potential risks.

  • Therapeutic Devices:
    • Class B: Devices for administering or exchanging energy.
    • Class C: Devices with potentially hazardous energy administration (e.g., ionizing radiation).
  • Diagnostic Devices:
    • Class B: Devices for supplying energy, capturing images, or monitoring physiological processes.
    • Class C: Devices for monitoring critical physiological parameters or emitting ionizing radiation.
  • Other Active Devices:
    • Class A: Devices not covered under therapeutic or diagnostic categories.

5. Special Categories

  • Medical Devices Incorporating Medicinal Products:
    • Class D: Devices with an integral medicinal product that has an ancillary action.
    • Class B: Devices with exempted medicinal products.
  • Medical Devices Incorporating Animal or Human Tissues:
    • Class D: Devices incorporating non-viable animal or human tissues or microbial/recombinant materials.
    • Class A: Devices with non-viable animal tissues contacting intact skin only.
  • Sterilization and Disinfection Devices:
    • Class C: Devices for sterilization or end-point disinfection.
    • Class B: Devices for disinfection before sterilization.
  • Contraceptive Devices:
    • Class C: Devices for contraception or preventing sexually transmitted diseases.
    • Class D: Implantable or long-term invasive contraceptive devices.

Why Understanding Classification Matters

Proper classification of medical devices is critical for:

  • Regulatory Compliance: Ensuring devices meet the necessary safety and efficacy standards.
  • Market Access: Facilitating timely approvals and reducing delays.
  • Patient Safety: Minimizing risks associated with device use.
  • Innovation: Encouraging the development of new and improved medical technologies.

Final Thoughts

The CDSCO MDR 2017 provides a robust framework for the classification of medical devices, ensuring that they are appropriately regulated based on their risk profile and intended use. By understanding these rules, manufacturers can navigate the regulatory landscape more effectively, while healthcare professionals and patients can have greater confidence in the safety and efficacy of medical devices.

At Satori One-Click Solution LLP, we are committed to simplifying the complexities of medical device classification and regulatory compliance. Whether you're a manufacturer or a stakeholder in the healthcare industry, we’re here to help you stay informed and compliant.

For more insights and expert guidance on medical device regulations, stay tuned to our blog or reach out to us directly. Together, let’s build a safer and more innovative future for healthcare.

Contact Satori One-Click Solution LLP

For expert guidance on medical device classification, regulatory compliance, or any other queries, feel free to reach out to us. We’re here to support you every step of the way.

Contact Details:

Let’s work together to ensure your medical devices meet the highest standards of safety and compliance. Reach out to us today!

Disclaimer: This blog is for informational purposes only and is based on the CDSCO MDR 2017. For specific regulatory advice, consult with experts or regulatory authorities.

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