IVDR Classification Overview

Under Regulation (EU) 2017/746 (IVDR), manufacturers are required to classify their in vitro diagnostic (IVD) devices according to Annex VIII, based on the device’s intended purpose and inherent risk. This classification system categorizes devices into four risk classes: A, B, C, and D, with Class A representing the lowest risk and Class D the highest.

How Are IVD Devices Classified?

The classification considers both:

The intended use of the device
The potential risk posed to patients and public health

This risk-based approach ensures appropriate regulatory controls are applied proportionally to the level of risk, ensuring patient safety without unnecessary burden on low-risk devices.

What’s New in IVDR Classification?

The IVDR classification system marks a significant shift from the previous directive (IVDD):

It aligns IVD device classification with the frameworks used for other medical devices.
It adopts international best practices as recommended by the Global Harmonization Task Force (GHTF).
It provides a more detailed and comprehensive classification methodology, enabling better oversight of emerging and novel IVD technologies.

This refined approach improves regulatory clarity and facilitates smoother market access for new IVD devices across the European Union.

IVDR Classification Rules

The responsibility for determining the correct risk class of an IVD device rests with the manufacturer. For devices classified as Class B, C, or D, the classification will be verified by the Notified Body. Competent authorities may also review classifications, including those of Class A devices.

Key Points for Manufacturers:

Maintain a documented justification for your classification decision within the IVDR Technical Documentation.
Carefully review all applicable classification rules to identify which corresponds to the highest risk class relevant to your device.
If multiple rules apply or the device has multiple intended uses, always assign the classification according to the rule that results in the highest risk class.

This approach ensures accurate risk-based classification, aligning with regulatory expectations and facilitating smoother conformity assessments.

IVDR Classification Overview

How Are IVD Devices Classified?

What’s New in IVDR Classification?

IVDR Classification Rules

Key Points for Manufacturers:

Ensure Accurate Classification — Protect Your Compliance

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