DIRUI obtains IVDR certification, making another leap forward

Date of publication：2024-06-16 21:52:09

DIRUI has acquired “EU Quality Management System Certificate (IVDR)” for a portfolio of its IVD products in CLIA, Clinical Chemistry, Coagulation and Urinalysis from TÜV SÜD Product Service, one of the largest EU notified body under the new IVDR.

About CE & IVDR

Conformité Européenne (CE) certification is a regulatory standard that verifies certain products are safe for sale and use in the European Economic Area (EEA). The in vitro diagnostic (IVD) medical devices to be sold in Europe must first be CE Marked to the IVD Regulation (IVDR). CE Marking is Europe’s version of marketing approval.

In Vitro Diagnostic Regulation (IVDR 2017/746) replaced IVDD starting from 26^th of May 2022, and is legally binding. The IVDR clearly lays out that manufacturers must demonstrate performance, safety and possible risks/controls of products prior to availability within the European marketplace.

Being IVDR-compliant, DIRUI focuses on the creation and maintenance of a robust QMS throughout the manufacturing process while ensuring the post market surveillance. With the aim of supplying safe, reliable products and service to the customers around the globe, DIRUI rapidly responds to the prevailing regulations and works tirelessly to meet the conformity by obtaining the CE mark in accordance with the IVDR.

As a company committed to lab diagnostic innovations, DIRUI, is dedicated to improving healthcare outcomes by creating better solutions that can meet the highest standards of quality, safety, and regulatory compliance.

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