A Great Achievement! Chroma ATE has successfully completed IVDR registration and is now IVDR compliant!
In major news for IVD medical devices, starting from May 26, 2022, the new In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) finally applies across the European Union. The IVDR officially replaces the In Vitro Diagnostic Medical Devices Directive (IVDD), and IVD manufactures are required to comply with the IVDR to continue supplying and selling their IVD products to the EU.
Chroma is very excited to announce that we have achieved an important milestone and are now fully compliant with IVDR (EU) 2017/746.
We have successfully fulfilled all requirements of IVDR 2017/746 and all requirements for the manufacture and sale of IVD products in the EU after May 26, 2022. We are dedicated to supplying and marketing our first Automated Nucleic Acid Extraction and PCR Setup system, the MagXtract® 3200, as a CE-IVD medical device under the new IVD regulations, and we will continue to provide high-quality products and services to our customers worldwide.
