Recently, Wondfo Biotech was awarded with EU quality management system certificate (IVDR) by TÜV SÜD. Besides, Wondfo’s products has obtained IVDR CE certificates such as HbA1c test kits (immunofluorescence assay) and C-reactive protein test kits (immunofluorescence assay).

 
Among these certificates, Wondfo’s IVDR quality management certificate is the first that is awarded to a Chinese company, and HbA1c test kits and CRP test kits are in the first batch of Chinese NPT products (Near Patient Testing) that have gained IVDR CE qualification.
 
With the IVDR quality management system certificated, Wondfo becomes a medical device manufacturer approved by IVDR CE—a newly launched EU regulation on medical devices. This achievement is a solid cornerstone for Wondfo to adapt to new procedures of CE qualification.
 
The certificate awarded is the first batch that Wondfo has gained under the IVDR CE system. Products mentioned above are the first batch of Chinese NPT products that have gained IVDR CE qualification, under C-class supervision. According to EU regulation, supervision on medical devices can be divided into four classes—A, B, C and D—among which D is the strictest class. Under stricter supervision, products above can be sold for use in both professional labs and POCT scenarios, which can exert positive influence on Wondfo’s businesses in EU member countries.


As a “visa” of products into European market, CE qualification is an obligatory requirement. IVDR EU 2017/746 will be wholly applied to EU countries from May 26^th, 2022.
 
After the official implementation of IVDR, stricter requirements will be applied in technical documents inspection, clinical assessment, supervision of public companies. It represents stronger regulation of EU on medical devices, as well as a more consistent standard of medical devices regulation in various EU members.