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IVD Consulting and Registration - In-Vitro Diagnostic

Risk Classification and Regulatory Process for In-Vitro Diagnostics

Unlike in the USA, IVDs are categorized into 4 Risk Classes. However, many of the requirements are the same. Only the structure of the Technical Documentation (Technical File) and some specific requirements differ.

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Risk Class A

low patient risk and
low public health risk

Risk Class B

moderate patient risk and/or
low public health risk

Risk Class C

high patient risk and/or
moderate public health risk

Risk Class D

high patient risk and
high public health risk

The requirements are similar for all classes, but the involvement of the Notified Body differs. Products in Class A are placed on the market by the manufacturer under its own responsibility; a Notified Body is not required in this case (exception: sterile products). For Classes B, C, and D, however, the conformity assessment is always conducted in collaboration with a Notified Body. Worldwide, only a few Notified Bodies for IVDs are notified under the IVDR (as of August 2026: approximately 19 bodies worldwide). Despite transition periods, this limited capacity results in waiting times and delays many marketing authorization projects. The EU’s NANDO database provides a current overview.

Labeling, UDI & EUDAMED

In addition, there are specific requirements for labeling and registration. Every IVD receives a UDI (Unique Device Identification), a unique product identifier that ensures the product’s traceability throughout its entire lifecycle. Manufacturers then register their IVD in EUDAMED, the European database for economic operators and products, through the European Authorized Representative if applicable.

Distribution and the supply chain are also mandatory requirements: Anyone who supplies distributors or imports products must be familiar with the respective roles and responsibilities. In any case, the performance of the respective test must be documented. It is advantageous if the IVD is already marketed in other markets (such as the U.S.) and the key performance data (sensitivity, specificity) are thus verifiably available. There are generally no specific threshold values or universally applicable acceptance criteria; instead, a risk-based approach applies, guided by the intended purpose and risk profile of the respective test.

In-Vitro Diagnostics Consulting and Registration

In vitro diagnostic medical devices must always be accompanied by Technical Documentation in accordance with Annex II of the IVDR. In addition, manufacturers have further obligations (the manufacturer does not necessarily have to “manufacture”; producers can do this), including:

IVD Diagnostic, In-Vitro Diagnostic, IVD Consulting

Proof of the “functioning” of the IVD is provided through performance evaluation and is based on scientific validity, analytical performance, and clinical performance. When an IVD is placed on the market, sensitivity and specificity are key performance indicators. The acceptance of these values generally results from risk management and must be documented in the instructions for use.

When placing the device on the market, sensitivity and specificity are essential factors. The acceptance of these values can be the result of Risk Management and must be included in the instructions for use.

According to the “German Network for Evidence-Based Medicine”, the term sensitivity means: the proportion of test-positive persons among all persons with a disease in a sample. Ultimately, it is the probability of identifying those who are actually sick with a test. A high level of sensitivity is sought when a disease is to be ruled out with a high degree of certainty.

Specificity, on the other hand, describes the proportion of test-negative individuals among all non-diseased individuals in a sample. The statement behind the value is intended to represent the probability of correctly identifying healthy subjects with a test.

The “quality” of a test is then determined by the product of specificity and sensitivity. This can very quickly lead to a test not being “meaningful” because the accuracy of detection is only 50-70%. In these cases, the patient is made to feel too insecure and further measures to detect diseases are indicated (e.g. biopsy).

WQS is an IVD Consultant for CE Mark certification. We invite you to contact us for a non-binding consultation.

In-vitro Diagnostics • IVDR 2017/746

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Frequently Asked Questions

Unlike the U.S., the EU categorizes IVDs into four risk classes (A, B, C, D). The EU IVDR (Regulation 2017/746) includes stricter classification rules, performance evaluation requirements and involves Notified Bodies for most products above Class A.

No. Only Class B, C, and D IVDs require review and certification by a Notified Body. Class A IVDs (non-sterile) can be self-certified by the manufacturer.

You need full Technical Documentation in accordance with Annexes II and III of IVDR, including device description, performance evaluation, design and manufacturing information and risk management data.

Yes. If your IVD has already demonstrated clinical performance in the U.S., the data can often be used as part of the EU performance evaluation, provided it meets EU evidence standards.

WQS provides full-service support including Classification, preparation of Technical Documentation, Clinical Evaluation Planning and assistance with EUDAMED Registration.

This page provides regulatory information and does not constitute legal advice. Regulatory requirements vary by jurisdiction.

Support for US companies to enter the European market. EU Rep, Certification, QM System, Technical Documentation, support of the Procedure, selection of a Notified Body, support of the Certification Procedure, preparation of a Clinical Evaluation, support of Clinical Studies, including the Logistical Concepts.

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St Petersburg, Florida 33701

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This page provides regulatory information and does not constitute legal advice. Regulatory requirements vary by jurisdiction.
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