We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress hp
Sign In
Advertise with Us
LGC Clinical Diagnostics

MINDRAY In-Vitro Diagnostics

As a global leader in in-vitro diagnostics, Mindray provides a wide range of efficient, reliable IVD solutions for la... read more Featured Products: More products

Download Mobile App




Mindray Takes Home 288 IVDR CE Certificates to Cover All IVD Product Segments

By LabMedica International staff writers
Posted on 03 Sep 2022
Print article
Image: Mindray recently obtained CE Certificate issued by TÜV SÜD (Photo courtesy of Mindray)
Image: Mindray recently obtained CE Certificate issued by TÜV SÜD (Photo courtesy of Mindray)

Mindray (Shenzhen, China) has obtained a CE Certificate issued by TÜV SÜD, a notified body designated under the EU's IVDR, bringing the total number of IVDR-certified products to 288 in the company’s IVD portfolio, covering hematology, biochemistry, immunoassay, specific proteins, HbA1c, among others.

CE certification is a pass for products to enter the EU market and circulate freely throughout the EU. It represents that the products comply with the relevant EU laws, regulations and standards. IVDR is short for the Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in-vitro diagnostics medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU. After the transitional period for the implementation of the IVDR, IVD medical devices that have not obtained IVDR CE certification will be denied access to the EU market. The newly launched IVDR EU 2017/746 aims to establish a modern and stricter regulatory framework to better protect the health and safety of the public and patients. Therefore, compared to the IVDD, the IVDR places more emphasis on the life-cycle management and continuous evaluation of products. The IVDR requires manufacturers to show that they have an effective quality management system (QMS) in place to ensure product safety, effectiveness, and post-market surveillance.

Mindray's CE-certified products include hematology analyzers and quality controls/calibrators, HbA1c analyzers, integrated CRP analyzers along with reagents and quality controls/calibrators, etc. After Mindray's β2-MG chemistry reagent obtained the first IVDR certification in China, all Mindray's internationally marketable chemistry analyzers, as well as their reagents, consumables, calibrators, and quality controls, have followed suit. Mindray's certified chemiluminescence immunoassay products now cover tumor markers, thyroid functions, reproductive hormones, adrenal hormones, myocardium, anemia and bone metabolism, liver fibrosis, inflammation, diabetes, hypertension, ToRCH, and other fields of testing. In addition, Mindray has completed relevant marketing procedures for the newly launched products this year.

Mindray's success in being one of China’s first recipients of the IVDR CE certification relies heavily on its sound and effective quality management system (QMS). Mindray has been placing top priority on quality, providing stable and safe medical equipment for customers from across the globe. In addition, the company has implemented stringent clinical trial and data control processes, which ensure the continuous optimization of management duties, design control, production control, error correction and prevention, post-market surveillance, and other modules. With its guaranteed quality and excellent services, Mindray’s IVD products and solutions have been installed in several top-tier hospitals and laboratories across Europe.

The EU is a key target market for Mindray IVD to expand overseas. All Mindray's internationally marketable products have obtained IVDR certification, which reflects the recognition of the notified body of their quality, safety and effectiveness, as well as their ability to meet the regulations and standards in various regions worldwide. This will help Mindray to expand in the global market and further consolidate its IVD’s presence in Europe. Going forward, Mindray aims to continue providing high quality products and solutions through independent R&D and innovation efforts and a robust QMS.

Related Links:
Mindray 

Gold Member
Chagas Disease Test
CHAGAS Cassette
Verification Panels for Assay Development & QC
Seroconversion Panels
New
Luteinizing Hormone Assay
DRG LH-Serum ELISA Kit
New
PSA Test
Humasis PSA Card

Print article

Channels

Clinical Chemistry

view channel
Image: QIP-MS could predict and detect myeloma relapse earlier compared to currently used techniques (Photo courtesy of Adobe Stock)

Mass Spectrometry-Based Monitoring Technique to Predict and Identify Early Myeloma Relapse

Myeloma, a type of cancer that affects the bone marrow, is currently incurable, though many patients can live for over 10 years after diagnosis. However, around 1 in 5 individuals with myeloma have a high-risk... Read more

Immunology

view channel
Image: The cancer stem cell test can accurately choose more effective treatments (Photo courtesy of University of Cincinnati)

Stem Cell Test Predicts Treatment Outcome for Patients with Platinum-Resistant Ovarian Cancer

Epithelial ovarian cancer frequently responds to chemotherapy initially, but eventually, the tumor develops resistance to the therapy, leading to regrowth. This resistance is partially due to the activation... Read more

Technology

view channel
Image: The HIV-1 self-testing chip will be capable of selectively detecting HIV in whole blood samples (Photo courtesy of Shutterstock)

Disposable Microchip Technology Could Selectively Detect HIV in Whole Blood Samples

As of the end of 2023, approximately 40 million people globally were living with HIV, and around 630,000 individuals died from AIDS-related illnesses that same year. Despite a substantial decline in deaths... Read more
Copyright © 2000-2025 Globetech Media. All rights reserved.