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
- Approval for COVID-19 rapid antigen tests intended for self-testing by lay persons
- Defined performance criteria for rapid SARS-CoV-2 antigen tests
- COVID-19 In Vitro Diagnostic Devices and Test Methods Database available
- European Commission gives details of how to prevent COVID-19 test failures
