WIZ-A101 obtains IVDR certifications
Recently, the portable immune analyzer WIZ-A101 from Wizbiotech has obtained the IVDR CE certification.
The In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 is the new EU legislation applicable to in vitro diagnostic (IVD) medical devices. The newly released IVDR has been upgraded from the original Directive to Regulation at the level of regulation, which indicates that the EU authorities have paid more attention to the field of medical devices. The new IVDR laws and regulations have greatly changed from the previous relevant applications, and have put forward stricter requirements in technical document review, clinical evaluation, post-market supervision and other aspects. For IVD enterprises, it has raised the entry threshold of the EU market and tightened its supervision, which brings great challenges and opportunities to enterprises. At the same time, Wizbiotech has successively carried out the handling of CE certificates under the new IVDR regulations to better cope with the arrival of the IVDR era.
