European Commission publishes Q&A guidance on COVID-19 tests

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

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