The Euro­pean Com­mis­sion has recent­ly pub­lished Q&A guid­ance on COVID-19 tests in the EU. The reg­u­la­to­ry con­text of this doc­u­ment is Direc­tive 98/79/EC on in vit­ro diag­nos­tic med­ical devices (IVDD) and NOT Reg­u­la­tion (EU) 2017/746 (IVDR).

The doc­u­ment sum­ma­rizes some of the points that have already been pub­lished in oth­er guid­ance in spring 2020. For exam­ple, it explains what types of tests are avail­able, what the legal frame­work for con­for­mi­ty assess­ments is and how the dif­fer­ent eco­nom­ic oper­a­tor roles should be understood.

Impor­tant­ly, there is also a Q&A sec­tion on pro­posed per­for­mance cri­te­ria.
The doc­u­ment can be down­loaded here.

Source: Euro­pean Commission

To receive fur­ther infor­ma­tion on this sub­ject, please notice the fol­low­ing arti­cles and con­tent on our website