In vitro diagnostics at risk: Covid-19 delays progresses towards the new European regulations
In order to keep them available to the health care system and to patients, more than 85% of IVDs will need to be updated in view of the new in vitro Diagnostic Regulation (IVDR) which is at risk due to the ongoing COVID-19 pandemic.
Posted on 26.11.2020
The remaining IVDR transition time is not sustainable and requires attention and effective solutions.
An exponential increase in swabs and serological tests, a continuously evolving demand for quicker and accurate diagnosis as well as for tests monitoring respiratory functions and diagnosing complications are some examples of the high pressure that the IVD sector had to face and has been responding to since the beginning of the COVID-19 pandemic.