MDSS would like to make you aware that the European authorities are concerned about the performance of IVD devices associated with COVID-19
The Commission has published a working document with performance criteria proposals for the different type of COVID- test methods and devices and as well guidance on descriptive information, quality control and safety measures. See link here.
MDSS strongly recommends reviewing the information and in particular the working document to:
- verify the performance of your company’s device is in line with what is proposed and expected by the by European Authority and
- verify the instructions for use contain the recommended information on performance as well as on quality control and safety measures
and implement further studies and changes as needed.
Additional attachments can be found on the European Commission website.
According to EU recommendations , timely and accurate COVID-19 laboratory testing is an essential part of the management of COVID-19 for slowing down the pandemic, supporting decisions on infection control strategies and patient management at healthcare facilities, and detecting asymptomatic cases that could spread the virus further if not isolated.
European Commission Q&A document on how to get products legally on the EU market and also provides information on how to place products on the EU market if you derogate from the normal requirements (check question 5).