Recently, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. obtained the CE extension certificate issued by TüV SüD, a famous EU notified body under the IVDR regulations. After this expansion, Mindray's in vitro diagnostic (IVD) business includes a total of 288 products including biochemistry, immunity, blood cells, specific proteins, and glycation analysis, all of which have obtained IVDR certification. It is understood that Mindray Medical is the first medical device manufacturer in China to obtain EU IVDR CE certification, and a medical device manufacturer with the largest number of certified products and complete production lines in China.

Upgrading of certification standards, raising the threshold for EU market access

CE certification is a pass for a product to enter the EU market and circulate freely throughout the EU, representing that the product complies with the EU laws, regulations and standards related to the product. The IVDR is an in vitro diagnostic medical device regulation promulgated by the European Union on May 5, 2017 to replace the original EU in vitro diagnostic medical device directive. After the transition period, in vitro diagnostic medical devices that have not obtained IVDR CE certification will no longer be placed on the EU market.

The new regulations aim to establish a modern and stricter regulatory framework to better protect the health and safety of the public and patients. Therefore, compared with the IVDD Directive, the IVDR regulations put forward stricter requirements on manufacturers' quality systems and product safety, effectiveness, and post-market supervision, and require products to meet traceability from production to the end.

The specific core changes are as follows: first, the standardization of classification rules requires the intervention and review of notified bodies; second, product certification requires more comprehensive clinical evidence; third, manufacturers face stricter post-market supervision; fourth, Established the EU medical device database and increased regulatory transparency.

After the biochemical business of Mindray IVD obtained the first domestic IVDR certification for β2-MG reagent, all the biochemical analyzers available for international sales have completed the IVDR conversion. The product is complete and ranks among the world's first-class echelons; Products newly launched this year, such as coagulation CX-9000 series products, also completed the relevant listing procedures according to IVDR requirements when the products were introduced to the market.