EU In Vitro Diagnostic Regulation (IVDR) Registration

Background of the In Vitro Diagnostic Medical Devices Regulation (IVDR)

The European Union officially released the In Vitro Diagnostic Regulation (IVDR) in 2017, replacing the previous In Vitro Diagnostic Directive (IVDD). The IVDR came into effect in May 2022, but the European Parliament approved a proposal in April 2024 to extend the transition period, with the longest extension possible until 2029. Compared to IVDD 98/79/EC, the IVDR imposes stricter regulatory requirements on IVDs, with higher standards for product performance assessment, clinical evidence, and post-market surveillance (PMS).

EU IVD Classification

The IVDR has four levels of risk based on patient and public health risks.

• Class A

Low patient and public health risks, such as laboratory instruments and buffer solutions.

• Class B

Moderate patient risk and/or low public health risk. This type of IVD is used for patient self-testing with lower risk than Class C, such as ovulation dipsets and cholesterol tests.

• Class C

High patient risk and/or moderate public health risk. This type of IVD is used to detect transmitted pathogens, and erroneous results can have serious consequences, such as cancer detection.

• Class D

High patient and public health risks. This type of IVD is used for testing or exposure to life-threatening pathogens or diseases with a high risk of transmission, such as HIV or hepatitis B detection.

About Us

In order to help IVD manufacturers successfully complete the compliance transition and ensure competitiveness and sustainable development on the European market, we provide comprehensive EU IVD regulation compliance services. Our services are designed to ensure that your products comply with the latest regulatory requirements and obtain the CE mark quickly and efficiently.

Our Services

• Product classification guidance

According to the characteristics of IVD products and the 7 classification rules of IVDR, we provide accurate classification guidance to ensure the correct evaluation path.

• Preparation of technical documents

Under the EU IVDR, IVDs of all risk levels need to prepare a series of technical documents to prove the safety and effectiveness of the product. To increase the likelihood of product approval, we provide extensive technical documentation preparation and review services to ensure complete, accurate and IVDR compliance.

• Update and interpretation of regulations

EU IVDR is constantly evolving and improving, and we keep you updated on the latest regulations to ensure that you are always up to date with the latest regulatory requirements.

• Registration process management and coordination
• Assist with optimizing the quality management system
• Authorized representative of the European Union

Why Choose Proregulations?

• Expert team's in-depth study of EU medical device regulatory requirements
• Develop an optimal compliance path to accelerate the approval process
• Rich practical experience, has helped dozens of enterprises to complete IVDR upgrade
• Global service network, timely response to client needs
• One-to-one customized solutions

With our standardized service process, we can help your IVD products complete IVDR certification efficiently during the regulatory transition period, so as to avoid delays in market access caused by compliance issues. We can be your trusted compliance partner and we will work closely with you to meet the challenges and opportunities presented by the EU IVDR regulations. If you are interested in our IVDR compliance services, please feel free to contact us.