The Medical Device Coordination Group (MDCG) has released the 2020-16 rev.4 guidance document, "Guidance on Classification Rules for in vitro Diagnostic Medical Devices "providing detailed insights on the classification of In-Vitro Diagnostic Medical Devices (IVDs) under Regulation (EU) 2017/746 (IVDR). Effective from March 2025, the guidance aims to ensure the consistent application of classification rules across the European Union (EU) and supports manufacturers, notified bodies, and regulators in understanding classification criteria.
In-Vitro Diagnostic Medical Device (IVD): A device used to examine specimens derived from the human body, including blood and tissue samples, to provide information for diagnostic, monitoring, or therapeutic purposes.
‘Companion diagnostic’ (CDx) is defined as a device which is essential for the safe and effective use of a corresponding medicinal product to:
a) identify, before and/or during treatment, patients who are most likely to benefit from the corresponding medicinal product; or
b) identify, before and/or during treatment, patients likely to be at increased risk of serious adverse reactions as a result of treatment with the corresponding medicinal product.
For a device to be defined as a CDx, there should be a link to a medicinal product with an International Non-proprietary Name (INN).
The classification of IVDs is determined based on their intended purpose and the level of risk they pose. Devices are categorized into four classes:
Class A: Low-risk devices (e.g., general laboratory instruments)
Class B: Moderate-risk devices (e.g., pregnancy tests)
Class C: High-risk devices (e.g., diagnostic tests for cancer)
Class D: Highest-risk devices (e.g., HIV or Hepatitis C diagnostic tests)
The application of classification rules also considers factors such as technology, specimen type, and software. Medical device software (MDSW) influencing diagnostic decisions falls under the same classification as the device it supports.
The guidance elaborates on the classification rules under Annex VIII of IVDR. Key rules include:
Rule 1
Classifies devices for detecting transmissible agents in blood, tissues, or organs for transfusion, transplantation, or administration. Examples include tests for HIV and Hepatitis B.
Rule 2
Devices for blood grouping or tissue typing for immunological compatibility are typically classified as Class C or Class D if they assess markers like ABO or Rhesus (Rh).
Rule 3
Covers devices detecting sexually transmitted agents, infectious agents in cerebrospinal fluid or blood, and those identifying genetic disorders. It also includes devices for cancer screening, companion diagnostics, and monitoring critical disease markers.
Rule 4
Devices for self-testing or near-patient testing are classified based on the potential risk to patients and the need for medical interpretation.
Rule 5
General laboratory devices, specimen receptacles, and non-critical instruments are typically classified as Class A or B.
Rule 6 and 7
Devices not covered by specific rules default to Class B. Control devices without assigned values also fall under Class B.
Manufacturers must assess their devices against these rules to determine the correct classification and follow appropriate regulatory pathways under Regulation (EU) 2017/746.
🔗 For full details, visit: MDCG 2020-16 rev.4 Guidance
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