IVDR Classification Rules

Updated July 2026

IVDR classification rules are the criteria used to determine the risk class of an in vitro diagnostic medical device under Regulation (EU) 2017/746.

This guide explains, for informational purposes, what classification rules are, where they are defined and which general criteria may be relevant to understand their structure.

Sheet with the title IVDR Classification Rules and reference to Regulation (EU) 2017/746

In this guide

General criteria of IVDR classification rules
General principles set out in Annex VIII
Class D devices
Class C devices
Devices for self-testing and near-patient testing
Class B devices
Class A devices
Classification rules and notified bodies
Why this guide does not reproduce all the rules in Annex VIII
Why this guide does not classify devices

General criteria of IVDR classification rules

IVDR classification rules are used to place an in vitro diagnostic medical device in one of the risk classes provided for by the Regulation.

Article 47 of Regulation (EU) 2017/746 states that devices are divided into classes A, B, C and D, taking into account the intended purpose of the devices and their inherent risks. Classification is carried out in accordance with Annex VIII.

The IVDR provides for four risk classes:

class A;
class B;
class C;
class D.

The application of the classification rules is based on the intended purpose of the device.

Classification also depends on elements such as the type of analyte or parameter detected, the clinical context, the risk associated with an incorrect result, the potential impact on the patient or public health, and the specific characteristics of the device.

Annex VIII provides that, if several classification rules apply to the same device, the rule resulting in the higher classification applies. In addition, when the manufacturer indicates multiple intended purposes and the device falls into more than one class, the device is classified in the highest class.

An important document for understanding this topic is MDCG 2020-16 rev.4 — Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746.

The European Commission also makes available the Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746, which collects guidance on borderline cases and classification topics.

In general terms, the higher the risk class, the greater the level of control required in the conformity assessment process.

General principles set out in Annex VIII

Annex VIII of the IVDR contains some general principles for the application of the classification rules.

If a device is intended to be used in combination with another device, the classification rules apply separately to each device.

Accessories for in vitro diagnostic medical devices are classified in their own right, separately from the device with which they are used.

Software intended to drive a device or influence the use of a device falls within the same class as the device. If, however, the software is independent of any other device, it is classified in its own right.

Calibrators intended to be used with a device fall within the same class as the device.

Control materials with quantitative or qualitative assigned values, intended for one specific analyte or multiple analytes, fall within the same class as the device.

These principles help explain why IVDR classification does not depend only on the general category of the product, but also on its intended purpose and on how the device is designed to be used.

Class D devices

Class D represents the highest risk class under the IVDR.

In general terms, this class includes devices intended to detect the presence of, or exposure to, transmissible agents in particularly critical contexts, for example when the use concerns blood, blood components, cells, tissues, organs or any of their derivatives, in order to assess their suitability for transfusion, transplantation or cell administration.

Class D may also include devices intended to detect the presence of, or exposure to, a transmissible agent that causes a life-threatening disease with a high or suspected high risk of propagation.

Devices intended to determine the infectious load of a life-threatening disease are also classified as class D when monitoring is critical in the process of patient management.

Class C devices

Class C includes several categories of in vitro diagnostic medical devices for which an incorrect result may have a significant impact on the clinical management of the patient, on the patient’s offspring or on relevant healthcare decisions.

This class may include, for example, devices intended to detect sexually transmitted agents, devices used in certain infectious disease contexts, devices used for screening, diagnosis or staging of cancer, human genetic tests, companion diagnostics, and devices used for certain assessments during pregnancy or in neonatal contexts.

According to Annex VIII, several devices intended for blood grouping, for determining feto-maternal blood group incompatibility or for tissue typing also fall within class C when used to ensure the immunological compatibility of blood, blood components, cells, tissues or organs.

Some specific markers, indicated in Annex VIII, instead result in classification as class D.

The detailed list of intended purposes relevant to class C is contained in the official text of Annex VIII.

Devices for self-testing and near-patient testing

The IVDR contains a specific rule for devices intended for self-testing and for devices intended for near-patient testing.

Devices for self-testing are generally classified as class C.

Some devices are exceptions and fall within class B, such as those intended to detect pregnancy, test fertility, determine cholesterol level, or detect glucose, erythrocytes, leucocytes and bacteria in urine.

Devices intended for near-patient testing are classified in their own right, based on their intended purpose and the applicable rules.

Class B devices

Class B includes, in general terms, in vitro diagnostic medical devices that do not fall within the categories provided for classes A, C or D under the conditions set out in Annex VIII.

Control materials without quantitative or qualitative assigned values also fall within class B.

The main reference for this provision remains the official text of Annex VIII.

Class A devices

Class A includes devices generally associated with a lower risk within the IVDR classification system.

According to Annex VIII, class A includes certain categories of devices such as:

products for general laboratory use;
accessories which possess no critical characteristics;
buffer solutions, washing solutions, general culture media and histological stains, when intended by the manufacturer to make them suitable for in vitro diagnostic procedures relating to a specific examination;
instruments specifically intended by the manufacturer to be used for in vitro diagnostic procedures;
specimen receptacles.

The main reference for identifying the included categories remains the official text of Annex VIII.

Classification rules and notified bodies

Device classification is connected to the conformity assessment pathway and, in many cases, to the involvement of a notified body.

Under the IVDR, devices belonging to classes B, C and D generally require the involvement of a notified body in the conformity assessment procedure.

Class A non-sterile devices do not normally require the involvement of a notified body, while for class A devices placed on the market in sterile condition, the involvement of the notified body is limited to the aspects relating to sterility.

For this reason, classification is a relevant element in the regulatory framework of the device, but this guide does not determine the class applicable to specific cases.

Why this guide does not reproduce all the rules in Annex VIII

This guide does not reproduce the full text of the rules because the official text of Annex VIII remains the main reference for consulting the rules in their complete wording.

MDCG 2020-16 rev.4 provides useful guidance for understanding the classification system for in vitro diagnostic medical devices.

For this reason, this guide only explains the general structure of the rules and refers to the official sources.

Why this guide does not classify devices

This guide does not determine the risk class of specific in vitro diagnostic medical devices.

Classification depends on elements such as the intended purpose, the type of analyte or parameter detected, the clinical context, the intended user, the risk associated with an incorrect result, any use in combination with other devices and the applicable regulatory context.

For this reason, this page is descriptive in nature and refers to the official texts and reference documents.

Informational note

This guide is published for informational purposes only and does not constitute regulatory, legal, technical or professional advice.

The information is based on publicly available sources and was checked as of the publication or last update date of this page. It may therefore not reflect subsequent changes or developments.

For assessments relating to specific cases, it is necessary to refer to the official texts, the updated documentation of the competent authorities and, where appropriate, qualified professionals.

Official sources

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