Recently, TüV SüD Product Service GmbH an EU Notified Body certified the first IVDR CE certificate in the field of chemiluminescence in China, and its winner is Shenzhen New Industries Biomedical Engineering Co., Ltd. (Snibe for short).

IVDR CE Certificate of Snibe

Credit: Shenzhen New Industries Biomedical Engineering Co., Ltd.

As a visa for products to enter the EU market, CE certification is a mandatory requirement of EU law for product access. The new EU In Vitro Diagnostic Regulation (IVDR, EU 2017/746) will replace the original In Vitro Diagnostic Directive (IVDD, 98/79/EC), for better serving the public and patients, protecting the safety of the public and patients .

What Are the Main Differences Between IVDR and IVDD?

1) IVDR has updated the product classification system. According to the requirements of the new product classification system, more in vitro diagnostic companies and products will have to pass the audit of the IVDR authorized announcement body to obtain CE certification.

e.g. thyroid function test reagent products do not require the approval of the notified body according to IVDD requirements. However, based on the requirements of IVDR, they need to be reviewed by the notified body to obtain a CE certificate before they can be legally sold in EU member states.

2) The IVDR certification process has undergone significant changes, with stricter requirements in terms of technical document review, clinical evaluation, and post-marketing supervision.

e.g. technical documentation need to be paid more attention to the review of performance evaluation. Clinical performance should meet the proprietary standard of in vitro diagnostic medical devices ISO 20916. In terms of post-marketing supervision, IVDR requires the establishment of post-marketing supervision plans and the completion of corresponding reports according to product classification levels.

From May 26, 2022, IVDR will be fully implemented. In order to ensure the continuity of product sales in the EU market, in vitro diagnostic companies must make reasonable plans, grasp the transition period of regulatory implementation, and obtain IVDR CE certification as soon as possible.

For a long time, Snibe has attached importance to the requirements of relevant laws and regulations of various countries around the world. In order to ensure that the quality management system and products complete the IVDR CE certification in a timely, Snibe has established an IVDR CE certification special group, which is responsible for the research and development, registration and quality teams. With joint efforts, we finally successfully won China's first IVDR CE certificate in the field of chemiluminescence, becoming the first medical enterprise in China to obtain the EU IVDR CE certificate in the field of chemiluminescence.

The first IVDR CE certificate (including thyroid function and tumor marker products) is the first step for the completion of IVDR CE certification for many Snibe products. It is also an extremely solid step for Snibe to become the pioneer in the global in vitro diagnostic field. Snibe will take it as a new development opportunity to further deepen the global market layout and contribute to the global in vitro diagnostic business.