IVDR Classification

IVDR Classification Guidance

In-vitro Diagnostic Devices, or IVDs, are classed as A, B, C, or D, depending on their intended purpose and inherent hazards, according to article 47.

D is the lowest classification (High personal risk, High public health risk)

ABO, Rhesus (including RHW1), Kell, Kidd, and Duffy systems, CHAGAS, Syphilis (used for blood donation screening), Hepatitis B and C, and so on.

C is the lowest classification (High personal risk, Moderate to low public health risk)

Examples include genetic testing, companion diagnostics, blood gas analyzers, Caner indicators, Rubella, and metabolic disease screening in newborns.

B-class (Moderate to low personal risk, Low public health risk)

Examples: Thyroid function tests, Infertility assays, Clinical Chemistry

Class A (Low personal risk, Low public health risk)

Instruments, Specimen receptacles, Wash buffers etc.

Conformity Assessment: The CE mark can be obtained through conformity assessment methods based on the device or set of devices’ categorization.

The EU Declaration of Conformity [Annex III] might be used to get the CE mark for Class A IVDs.

The CE mark might be obtained for Class B IVDs by following the conformity assessment path of Quality Management System Assurance [Annex IX] followed by Assessment of Technical Documentation per Category Device [Annex IX 4.4-4.8].

The CE mark for Class C IVDs might be obtained using the following conformity assessment routes:

Quality Management System Assurance [Annex IX], Assessment of Technical Documentation per generic device [Annex IX 4.4-4.8], and Competent Authority Consultation for Companion Diagnostics [Annex IX 5]. .2]
OR

Type Examination [Annex X] (includes Technical Documentation), Production Quality Assurance [Annex XI], and Competent Authority consultation for Companion Diagnostics [Annex X 3].

The CE mark for Class D IVDs might be obtained using the following conformity assessment routes:

Assurance of the Quality Management System [Annex IX], Assessment of Technical Documentation [Annex IX Ch II], and Verification by an EU Reference Laboratory OR

Type Examination [Annex X] (includes Technical Documentation), Production Quality Assurance [Annex XI], and EU Reference Laboratory Verification

 

 

ALS INTERNATIONAL LTD. has been entrusted with regulatory papers and support by leading device makers. Our team of specialists will walk you through the complex requirements that relate to your IVDR classification and IVDR CE Certification, guiding you through the procedure at every step.

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