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

By LabMedica International staff writers
Posted on 03 Sep 2022
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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.

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