Autobio Obtained the First EU IVDR CE Certification

Recently, Autobio's thyroid functional magnetic particle chemiluminescence series reagents obtained the EU IVDR CE certification issued by TüV SüD. This is the first series of Autobio’s products to obtain the EU IVDR CE certification.

CE certification is a mandatory requirement for product access in the EU market and is regarded as a "visa" for products to enter the European market. Since May 26, 2022, the European Union will fully implement the in vitro diagnostic medical device regulations EU 2017/746 (IVDR). The new regulations put forward stricter requirements for technical document review, clinical evaluation, and post-marketing supervision. These regulatory changes reflect the strengthening of the EU market’s supervision of the medical device field, requiring manufacturers to have better product quality, as well as equipment traceability through the supply chain to the end user.

Autobio is committed to providing users with products and services that are more cost-effective and quality-price ratio. Thyroid functional magnetic particle chemiluminescence series reagents have obtained the EU IVDR CE certification, marking the continuous improvement of the quality of Autobio's products. The EU certification switching work has laid a solid foundation.