The World Health Organisation has said that COVID-19 is no longer a world-wide urgent health situation. What does this mean for the future regulation of COVID-19 tests in the context of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)?
When the European Commission released a Q&A document on COVID-19 tests in February 2021 it announced that COVID-19 IVD tests will as a rule be classified in the highest risk class, but an annotation says that the classification hinges on the intended purpose as declared by the manufacturer.
Some question if COVID-19 tests should be in the highest risk classification now that it is deemed merely as a recognised and continuing health matter and no longer a world-wide health emergency. The answer is decisive in when legacy COVID-19 products moving around on the market must comply with IVDR. In the wake of the publication of the IVDR amending regulation, legacy class D IVD medical devices now have to comply with the IVDR by 26 May 2025. However, if COVID-19 tests are regarded as moderate risk now, they would have an extra year or two to comply.
Source: Medtech Insight (an Informa product)