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Understanding the Classification of In Vitro Diagnostic Medical Devices (IVDs) as per CDSCO MDR 2017
SATORI ONE CLICK SOLUTION LLP
March 16, 2025
Home Medical Devices

In vitro diagnostic medical devices (IVDs) are critical tools in healthcare, enabling the diagnosis, monitoring, and management of diseases through the analysis of samples like blood, tissue, or urine. The Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health and Family Welfare, India, has established the Medical Devices Rules (MDR) 2017 to regulate IVDs. These rules ensure that IVDs are classified based on their risk level, intended use, and potential impact on patient health.

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

Basic Principles for Classification of IVDs

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

  1. Intended Purpose: The classification of an IVD is primarily based on its intended purpose as defined by the manufacturer.
  2. Combination with Other Devices: If an IVD 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 an IVD is classified in the same category as the device itself.
  4. Standalone Software: Standalone software that analyzes results from an IVD analyzer is classified in the same category as the IVD it controls or influences.
  5. Calibrators: Calibrators used with reagents are classified in the same category as the reagent.
  6. 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 IVDs

The CDSCO MDR 2017 outlines specific parameters for classifying IVDs 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. IVDs for Detecting Transmissible Agents

IVDs used to detect transmissible agents are classified based on the risk associated with the agent and the potential impact of an erroneous result.

  • Class D: IVDs used to detect:
    • Transmissible agents in blood, blood components, cells, tissues, or organs for transfusion or transplantation.
    • Life-threatening diseases with a high risk of propagation (e.g., HIV, Hepatitis B).
  • Class C: IVDs used to detect:
    • Sexually transmitted agents (e.g., Chlamydia, Syphilis).
    • Infectious agents in cerebrospinal fluid or blood with limited propagation risk (e.g., Cryptococcus neoformans).
    • Infectious agents where an erroneous result could cause severe disability or death (e.g., Methicillin-resistant Staphylococcus aureus).
    • Pre-natal screening for immune status (e.g., Rubella, Toxoplasmosis).
    • Infective disease status or immune status where an erroneous result could lead to life-threatening decisions (e.g., Cytomegalovirus in transplant patients).
    • Cancer diagnosis or disease stage screening.
    • Human genetic testing (e.g., cystic fibrosis, Huntington's disease).
    • Monitoring medicinal products or biological components where an erroneous result could lead to life-threatening decisions (e.g., cardiac markers, prothrombin time testing).
    • Management of life-threatening infectious diseases (e.g., viral load testing for HIV or Hepatitis C).
    • Screening for congenital disorders in the foetus (e.g., Down's syndrome, spina bifida).

2. IVDs for Blood Grouping or Tissue Typing

IVDs used for blood grouping or tissue typing are classified based on their intended use.

  • Class C: IVDs used for blood grouping or tissue typing to ensure immunological compatibility for transfusion or transplantation.
  • Class D: IVDs used for blood grouping or tissue typing according to systems like ABO, Duffy, Kell, Kidd, or rhesus (e.g., HLA typing).

3. IVDs for Self-Testing

IVDs intended for self-testing are classified based on the criticality of the test results.

  • Class C: IVDs used for self-testing.
  • Class B: IVDs used for self-testing to obtain:
    • Non-critical test results (e.g., cholesterol levels).
    • Preliminary test results requiring laboratory confirmation.

4. IVDs for Near-Patient Testing

IVDs used for near-patient testing are classified based on their intended use.

  • Class C: IVDs used for near-patient testing in blood gas analysis, blood glucose determination, anticoagulant monitoring, diabetes management, or testing for C-reactive protein and Helicobacter pylori.

5. IVDs Used in Diagnostic Procedures

IVDs used in diagnostic procedures are classified based on their role in the diagnostic process.

  • Class A:
    • Reagents or articles with specific characteristics for a diagnostic procedure.
    • Instruments specifically used for diagnostic procedures.
    • Specimen receptacles.

6. Other IVDs

IVDs that do not fall under the above categories are classified as follows:

  • Class B: IVDs not covered under sub-paragraphs (i) to (v).
  • Class B: Substances or devices used to assess the performance of an analytical procedure without a quantitative or qualitative assigned value.

Why Understanding IVD Classification Matters

Proper classification of IVDs is critical for:

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

Final Thoughts

The CDSCO MDR 2017 provides a robust framework for the classification of IVDs, 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 IVDs.

At Satori One-Click Solution LLP, we are committed to simplifying the complexities of IVD 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.

Contact Satori One-Click Solution LLP

For expert guidance on IVD 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.

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

đź”–Tags: CDSCO Guidelines for IVDs CDSCO MDR 2017 Class A IVDs Class B IVDs Class C IVDs Class D IVDs In Vitro Diagnostic Medical Devices IVD Blood Grouping IVD Classification IVD Diagnostic Procedures IVD Intended Use IVD Near-Patient Testing IVD Regulatory Framework IVD Risk Classification IVD Self-Testing IVD Software Classification IVD Tissue Typing IVD Transmissible Agents Regulatory Compliance for IVDs
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