IVDR Classification Services

Cert3Global provides expert IVDR Classification Services to help manufacturers accurately determine the classification of their in vitro diagnostic (IVD) devices under Regulation (EU) 2017/746. We support manufacturers in identifying the appropriate risk class, understanding regulatory obligations, and selecting the correct conformity assessment pathway for successful EU market access.

Our regulatory experts help simplify the classification process, ensuring your device aligns with IVDR requirements and is prepared for the appropriate level of regulatory review.

Expert IVDR Classification Support for IVD Manufacturers

The EU In Vitro Diagnostic Medical Devices Regulation (IVDR) introduced a new risk-based classification system for IVD devices. Under IVDR, devices are classified according to their intended purpose and inherent risks and are assigned to one of four classes: Class A, Class B, Class C, or Class D. This represents a significant shift from the previous IVDD framework and subjects many devices to higher levels of regulatory scrutiny.

Determining the correct classification is one of the most critical steps in the IVDR compliance journey because it directly affects the conformity assessment route, the extent of technical documentation required, and the level of Notified Body involvement.

Cert3Global provides practical IVDR classification support to help manufacturers understand their regulatory obligations and establish a clear path toward compliance and CE marking.

What is IVDR Classification?

IVDR classification is the process of determining the risk class of an in vitro diagnostic medical device under Regulation (EU) 2017/746. The regulation classifies IVD devices based on their intended purpose and the potential risks they pose to both individual patients and public health.

Under IVDR, IVD devices are categorized into four classes:

Class A

Low individual risk and low public health risk devices. Most non-sterile Class A devices can follow self-certification procedures.

Class B

Devices that present moderate risk to individuals and low public health risk and generally require Notified Body assessment.

Class C

Devices that present high individual risk and moderate public health risk and require increased regulatory scrutiny and conformity assessment.

Class D

Devices that present high individual risk and high public health risk and are subject to the highest level of regulatory oversight.

The classification of your device determines the regulatory requirements that must be fulfilled before the product can be placed on the European market.

Who Needs EU IVDR Consulting Services?

IVDR classification follows a risk-based approach that considers both the intended use of the device and the potential consequences of an incorrect result. Manufacturers are responsible for determining the appropriate classification of their devices by applying the classification rules outlined in Annex VIII of Regulation (EU) 2017/746.

The classification framework was introduced to create greater alignment with international regulatory practices and provide a more comprehensive approach to evaluating in vitro diagnostic devices.

Factors considered during classification include:

Intended purpose of the device
Type of analyte being measured
Intended user population
Clinical impact of incorrect results
Potential risks to patients and public health
Whether the device is intended for self-testing
Whether the device is intended to detect transmissible agents

These factors collectively determine the level of regulatory oversight required for the device.

IVDR Classification Rules

Manufacturers are responsible for identifying the applicable risk class of their IVD devices. While manufacturers perform the initial classification, the assigned classification may be verified by Notified Bodies for Class B, Class C, and Class D devices. Competent authorities may also review classifications where necessary. Therefore, manufacturers should maintain documented justification supporting their classification decisions within their IVDR technical documentation.

The IVDR classification rules are designed to ensure that devices with higher potential risks undergo stricter conformity assessment procedures. Accurate classification is therefore essential because it directly impacts:

Conformity assessment requirements
Notified Body involvement
Technical documentation expectations
Performance evaluation obligationsrequiring CE marking for IVD devices
Regulatory timelines and market access strategies

An incorrect classification can result in delays, additional regulatory requirements, and challenges during conformity assessment.

Technical Documentation Support

Technical documentation plays an important role in demonstrating compliance with IVDR requirements and supporting the classification rationale for an IVD device.

Cert3Global provides technical documentation support to help manufacturers prepare and organize the information required for IVDR compliance. Our team works with manufacturers to ensure that classification decisions are properly documented and supported by evidence that aligns with regulatory expectations.

We help manufacturers establish documentation that supports:

Device intended purpose
Classification rationale
Performance evaluation requirements
Risk management activities
Regulatory compliance records
Conformity assessment preparation

Well-structured technical documentation not only supports classification decisions but also helps streamline the overall regulatory process and prepares manufacturers for future assessments and reviews.

Why Choose Cert3Global?

Cert3Global provides practical and reliable regulatory consulting services for medical devices and in vitro diagnostic devices worldwide. Our team supports manufacturers throughout their IVDR compliance journey, helping them understand regulatory requirements and make informed decisions regarding device classification and market access.

We offer:

IVDR classification support
Regulatory strategy guidance
Technical documentation assistance
Conformity assessment preparation
Regulatory consulting for IVD manufacturers
End-to-end compliance support

Our objective is to simplify regulatory complexity and help manufacturers achieve compliance efficiently and confidently.

Get Expert Support for IVDR Classification!

Determining the correct classification of an in vitro diagnostic device is a fundamental step toward IVDR compliance and successful EU market entry. An accurate classification helps define your regulatory pathway, documentation requirements, and conformity assessment obligations.

Cert3Global provides expert guidance to help manufacturers navigate IVDR classification requirements and establish a clear and compliant strategy for bringing IVD devices to the European market.

FAQs

What is IVDR classification?

IVDR classification is the process of assigning an IVD device to Class A, B, C, or D based on its intended purpose and inherent risks.

Who is responsible for classifying an IVD device?

Manufacturers are responsible for determining the classification of their IVD devices under Annex VIII of Regulation (EU) 2017/746.

Why is IVDR classification important?

The classification determines the conformity assessment pathway, documentation requirements, and level of Notified Body involvement required for compliance.

Do all IVDR devices require a Notified Body?

No. Most non-sterile Class A devices can be self-certified, while Class B, Class C, and Class D devices generally require Notified Body involvement.

Can an incorrect classification delay market access?

Yes. Incorrect classification can lead to additional regulatory requirements, delays in conformity assessment, and challenges during the compliance process.

Disclaimer

Cert3Global provides regulatory consulting and UK Responsible Person services for cosmetics. Compliance outcomes and market access remain subject to applicable UK cosmetic regulations.