Wow! A Chinese IVD company obtained CE certification within 10 days, there must be some experts behind this achievement!
This article introduces CeCert, a newly added public announcement agency under the EU, which has become an NB agency for issuing CE certificates under the IVDD regulation and is widely favored by domestic manufacturers. Meanwhile, the team at Pure Global has helped three new COVID-19 antigen test kits from domestic manufacturers obtain CE certification acceptance letters from this agency in a short period of time, as the time is running out for the opportunity to obtain CE certificates. The article also introduces CE 1434 self-assessment certification, as well as Pure Global as a one-stop service provider for the entire process, helping domestic manufacturers achieve the level of technical document writing in Europe and the ability to communicate and provide service support in China. Finally, the article reminds manufacturers to seize the last five months of the opportunity to obtain CE certification before the implementation of the new IVDD regulations, while the public announcement agency can still handle and accept cases.
2023-03-27