12th March 2020 Content supplied by: rapidmicrobiology.com
Full List of CE-Marked COVID-19 Diagnostics
Image: Transmission electron microscope image of SARS-CoV-2 emerging from the surface of cells cultured in the lab (Courtesy of NIAID)
It will be two years from now before the new CE-IVD directive (IVD Regulation (EU) 2017/746) will be implemented and with that a new publicly accessible database EUDAMED (European database on medical devices). So, at present, if you wanted to find out which COVID-19 diagnostic kit was CE-marked, you needed to scour the internet for this information. At present only national competent authorities have access to the current database.
So here rapidmicrobiology.com have done the leg work and compiled a full list of the CE-marked Covid-19 diagnostic devices. Please visit our test method guide here and scroll down to the 'Suppliers Listing', you will find the full list of CE-marked COVID-19 products. Each entry will allow direct contact to the manufacturer for any queries you may have. The page also contains a summary of the underlying technology associated with the test kits available on the market which include point of care tests, immunoassay and standard RT-PCR tests.
Only the products in that table that have CE-IVD beside their name have received the approval to market their product within the European Economic Area.
Also, please note, if you are a manufacturer and have received CE-marking and it is not listed, please use the 'Request Information' button at the bottom of THIS page to let us know.
Date Published: 12th March 2020