Good News! The first 69 products of Biotest obtained the EU IVDR certificate

Recently, Hangzhou Biotest Biotech obtained the CE certificate (IVDR) issued by TÜV SÜD, an authoritative EU notified body, under the IVDR regulation, which covers the first batch of 69 products of the company. The first batch of certified products mainly focus on the field of drug abuse testing, and also cover some items in the fields of infectious disease testing, women's health testing and tumor marker testing. The issuance of this batch of certificates makes Biotest one of the first manufacturers in China to have a more complete range of EU IVDR certified drug abuse testing products.

CE certification is a pass for products to enter the market circulation in the EU and European Free Trade Area countries, representing that the product complies with the EU laws, regulations and standards related to the product, and is a commitment of the enterprise to consumers, which can increase the trust of consumers in the product and at the same time reduce the risk of selling in the European market.

The new EU In Vitro Diagnostic Medical Devices CE Certification Regulation (IVDR, EU2017/746) was officially published and came into force on May 25, 2017 and will be implemented from May 26, 2022. Since the implementation date, the EU IVDR regulation will replace the former EU In Vitro Diagnostic Medical Devices Directive (IVDD, 98/79/EC) to regulate in vitro diagnostic medical devices in the EU market, and products that have obtained CE certification before May 26, 2022 will be gradually switched over during the transition period according to the risk level. The new IVDR regulation classifies IVD products into four categories, with risk ranked from low to high: Class A, Class B, Class C and Class D. Class A is sterile, while Class B, C and D require the EU Notification Body (Notify Body) to issue certificates before the products can enter the EU market. The new IVDR regulation aims to establish a modern and stricter regulatory framework in order to better protect the health and safety of the public and patients. Compared with the IVDD Directive, the IVDR Regulation imposes stricter requirements on manufacturers' quality systems and on the safety, efficacy and post-market surveillance of products, and requires products to meet traceability from production to endpoint.