EU 2017/746 IVDR

The EU Regulation 2017/746 on In Vitro Diagnostic Medical Devices (IVDR), which fully replaced the previous Directive 98/79/EC as of May 26, 2022, introduces a stricter regulatory framework for IVD devices in the European Union. It reclassifies IVDs into four risk-based classes (A, B, C, D) and significantly increases the role of Notified Bodies in conformity assessments, particularly for higher-risk devices. The IVDR mandates robust clinical evidence to demonstrate the safety and effectiveness of IVDs, along with comprehensive post-market surveillance. Additionally, it enhances transparency and traceability through the European Database on Medical Devices (EUDAMED) and the implementation of Unique Device Identifiers (UDI). This regulation ensures that IVD devices on the European market meet high standards of safety and performance, aligning with global practices and improving patient safety.

Key Objectives

Enhance Patient Safety: Ensure that all in vitro diagnostic devices meet stringent safety and performance standards to protect patients and public health.

Increase Regulatory Oversight: Reclassify IVD devices into risk-based categories with greater involvement of Notified Bodies, particularly for higher-risk devices.

Ensure Robust Clinical Evidence: Require manufacturers to provide comprehensive clinical evidence demonstrating the safety, effectiveness, and performance of their devices.

Strengthen Post-Market Surveillance: Implement rigorous post-market surveillance systems to monitor device performance and quickly address any safety issues once the device is on the market.

Improve Transparency and Traceability: Enhance the traceability of IVD devices through the European Database on Medical Devices (EUDAMED) and the use of Unique Device Identifiers (UDI), allowing for better tracking and recall processes.

Align with Global Standards: Harmonize EU regulations with international standards to facilitate global trade and ensure consistency in the safety and efficacy of IVD devices across markets.

IVDR Medical Device Classification

In-Vitro Diagnostic Devices (IVDs) are classified into four categories: Class A, B, C, and D, based on their intended purpose and inherent risks. Class A represents the lowest risk category, while Class D denotes the highest risk.

The new classification system for IVD medical devices marks a significant departure from the previous IVD directive. This reform is among the few radical changes introduced by the new regulations, aligning the classification of IVD medical devices with that of other medical devices and adhering to international standards advocated by the Global Harmonization Task Force (GHTF).

This enhanced classification system offers a more comprehensive approach compared to the previous directive, ensuring better alignment with global practices and facilitating smoother application processes for new IVD devices. It represents a crucial improvement, enhancing regulatory compliance and ensuring the safety and performance of IVD medical devices.

IVD Classification with Examples

Class A (Low Risk)

These devices are considered to have the lowest risk. They are generally non-invasive and have minimal patient interaction.

Examples:

Reagents for blood glucose monitoring - Used by individuals with diabetes to monitor their blood sugar levels.

Pregnancy test kits - Over-the-counter tests to detect pregnancy.

Urine test strips - Used to detect various conditions like urinary tract infections.

Hematology pipettes - Tools used for measuring blood samples in a lab.

Specimen receptacles - Containers used to collect and transport specimens.

As per EU IVDR Classification for Class A devices (Excluding Sterile), CE marking could be achieved through EU Declaration of Conformity [Annex III].

Class B (Moderate Risk)

These devices pose a moderate risk to patients and require more oversight compared to Class A devices. They often involve more complex testing procedures.

Examples:

HIV test kits - Tests for the presence of HIV antibodies or antigens.

Fertility test kits - Assess hormone levels to evaluate fertility.

Cholesterol test strips - Used to measure cholesterol levels in blood.

Hepatitis B/C test kits - Detect the presence of hepatitis B or C viruses.

Blood gas analyzers - Devices that measure the levels of gases like oxygen and carbon dioxide in blood samples.

As per EU IVDR Classification for Class B devices, CE marking for medical devices could be achieved through below conformity assessment route

Quality Management System Assurance [Annex IX] followed by Assessment of Technical Documentation per category device [Annex IX 4.4-4.8].

Class C (High Risk)

These devices are associated with a higher risk and generally involve more critical diagnostic procedures.

Examples:

In vitro diagnostic assays for cancer biomarkers - Tests that detect cancer-related markers.

Genetic testing kits - Used for detecting genetic disorders or predispositions.

HLA typing tests - Used for tissue typing in organ transplantation.

Molecular diagnostic tests for infectious diseases - Such as tests for tuberculosis or COVID-19.

Tests for drug levels in blood - Used to monitor therapeutic drug levels or drug abuse.

As per EU IVDR Classification for Class C devices, CE marking could be achieved through any of the below conformity assessment routes

Quality Management System Assurance [Annex IX] followed by Assessment of Technical Documentation per generic device [Annex IX 4.4-4.8] followed by For Companion Diagnostics Competent Authority consultation [Annex IX 5.2]

Type Examination [Annex X] (includes Technical Documentation) followed by Production Quality Assurance [Annex XI] followed by For Companion Diagnostics Competent Authority consultation [Annex X 3]

Class D (Very High Risk)

These devices are considered to have the highest risk and are usually critical for patient management. They often involve a direct impact on diagnosis and patient outcomes.

Examples:

Tests for HIV viral load - Essential for managing HIV infection and treatment.

Tests for molecular diagnostics of genetic disorders - Such as cystic fibrosis or sickle cell disease.

In vitro diagnostic tests for determining antimicrobial resistance - Critical for managing infections.

Pre-natal screening tests for chromosomal abnormalities - Such as tests for Down syndrome.

Tests for determining transplant organ compatibility - Critical for successful organ transplants.

As per EU IVDR Classification for Class D devices, CE marking could be achieved through any of the below conformity assessment routes

Quality Management System Assurance [Annex IX] followed by assessment of Technical Documentation [Annex IX Ch II] followed by Verification by EU Reference Laboratory

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

IVDR Classification Rules

In accordance with the EU IVDR 2017/746, the classification of in vitro diagnostic (IVD) devices is crucial for determining the appropriate regulatory pathway and ensuring device safety and efficacy. The responsibility for accurately identifying the applicable risk class lies with the manufacturer. For Classes B, C, and D devices, the Notified Body will verify the classification, and competent authorities may also review the classification of Class A devices. Manufacturers must maintain a documented rationale for their classification decisions in their IVDR technical documentation.

The classification rules under the IVDR are outlined to determine the appropriate risk class for IVD devices. The rule leading to the highest risk class applicable to the device must be applied if multiple rules are relevant or if the device serves various intended uses.

Rule 1: This rule primarily applies to devices in Class D, including those used for:

Determining the infectious load of a life-threatening disease.

Detecting transmissible agents in blood, cells, tissues, or organs, as well as blood components.

Rule 2: This rule generally applies to devices in Class C and, in some cases, Class D. It pertains to devices intended for:

Blood grouping or tissue typing to ensure the immunological compatibility of blood, blood components, cells, tissues, or organs intended for transfusion, transplantation, or cell administration.

Rule 3: Devices under this rule typically fall into Class C. They are used for:

Detecting sexually transmitted diseases.

Assessing the status of the fetus or embryo.

Conducting pre-natal screening of women.

Determining infective disease status or immune status.

Screening, diagnosing, or staging cancer.

Human genetic testing.

Screening for congenital disorders in embryos or fetuses.

Identifying congenital disorders in newborns.

Rule 4: Devices falling under this rule are generally in Class C, with some in Class B, and are intended for self-testing, excluding those for:

Pregnancy detection.

Fertility testing.

Cholesterol, glucose, erythrocyte, leucocyte, virus, bacteria, or urine level determination.

Rule 5: This rule generally applies to Class A devices, which include:

General laboratory use accessories such as buffer solutions, washing solutions, culture media, and histological stains used in IVD procedures, as well as some instruments for in vitro procedures and specimen receptacles.

Rule 6: Class B devices are not covered by any of the rules specified in Rules 1 through 5 of the EU IVDR.

Rule 7: This rule is generally applicable to Class B devices, specifically:

Devices that serve as controls without a quantitative or qualitative assigned value.

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