Back in August, we have issued an article about a new guidance document published by the Medical Device Coordination Group (MDCG), MDCG 2021-21. The guidance document lays out specific requirements for the performance evaluation of IVD tests related to SARS-CoV-2.
We would like to make affected manufacturers aware again of the importance of this guidance document. Under the current IVD Directive (IVDD), the included provisions are voluntary as long as a good justification is in place to not follow the guidance.
However, the document also says that the Commission considers adopting the included provisions as common specifications under Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). Common specifications also have a voluntary character, but in practice it is expected it will be impossible to justify an alternative approach.
As a consequence, manufacturers should ensure to comply with the guidance requirements also in preparation for the IVDR. SARS-CoV-2 tests will have to fully comply to the IVDR by May 26, 2022 and tend to fall into the highest risk class D with a much higher level of scrutiny including certification by a notified body.
Source: European Commission
Accompanying this subject we recommend the following content on our website
- The European Commission publishes important guidance on the requirements for COVID-19 tests under the IVDD
- Guidance document on the impact of genetic variants on SARS-COV-2
- European Commission publishes Q&A guidance on COVID-19 tests
- Approval for COVID-19 rapid antigen tests intended for self-testing by lay persons
- Defined performance criteria for rapid SARS-CoV-2 antigen tests
- European Commission gives details of how to prevent COVID-19 test failures