Understanding IVDR Device Classification: A Practical Approach

IVDR Device Classification Overview

One of the most significant changes introduced by the IVDR is the shift from a list-based classification system (under the IVDD) to a risk-based classification system with four classes: A, B, C, and D.

The Four Risk Classes

Class A represents the lowest risk category and includes devices such as general laboratory reagents, specimen receptacles, and wash solutions. These devices can be self-certified by the manufacturer without Notified Body involvement (except for sterile devices).

Class B includes devices for determining blood groups, detecting infectious agents where the result is not decisive for patient management, and self-testing devices not covered by higher classes. Examples include pregnancy self-tests and cholesterol self-tests.

Class C encompasses devices used for blood screening, companion diagnostics, genetic testing, and devices for monitoring therapeutic drug levels. This class requires Notified Body assessment of the technical documentation.

Class D is the highest risk class, reserved for devices used to detect transmissible agents in blood, blood components, cells, tissues, or organs, as well as devices for determining infectious disease status where there is a risk of propagation. HIV and hepatitis screening tests are typical Class D devices.

Classification Rules

IVDR Annex VIII contains seven classification rules that determine device classification:

1. Rule 1: Devices for personal use (self-testing) — minimum Class C
2. Rule 2: Devices for near-patient testing — classification based on underlying rules, minimum Class B
3. Rule 3: Devices for detecting transmissible agents — Class D for high-risk agents
4. Rule 4: Devices for blood group determination — Class C or D depending on the specific application
5. Rule 5: Companion diagnostics — Class C
6. Rule 6: Devices for specific analyte categories — varies by intended purpose
7. Rule 7: All other devices — Class A (default)

Practical Steps for Classification

When classifying your IVD device under IVDR, follow these steps:

1. Define the intended purpose clearly and completely
2. Identify all applicable classification rules
3. Apply the highest applicable classification
4. Document your classification rationale thoroughly
5. Verify with your Notified Body if uncertain

Impact on Compliance Strategy

Your device classification directly impacts your conformity assessment route, documentation requirements, and timeline for IVDR compliance. Higher-risk classifications require more extensive technical documentation, Notified Body involvement, and potentially EU Reference Laboratory consultation.