Tag Archives: covid-19

Authorization of medical devices in Europe in the context of COVID-19

The standard registration procedure* for medical devices, in vitro diagnostic devices (IVD) and personal protective equipment includes a Conformity Assessment.  Depending on the risk class of MD, IVD and the category of personal protective equipment, the manufacturer either registers its product independently through the EUDAMED system (for non-sterile MDs that are not measuring instruments, I risk class), or applies to

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Emergency Use Authorization for medical devices and drugs to fight against COVID-19 in the United States

The COVID-19 pandemic has made adjustments to many areas of society, including the regulatory sector for drugs and medical devices (MD). In this regard, in many countries, legislation regarding the introduction of drugs and MD to the market has been adapted to the emergency situation. For example, in Russia, Government Resolution No. 430 was adopted for MD, allowing to approve

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The Covid-19 environmental disaster

The covid-19 pandemic was a catastrophe of the 21st century, not only for humanity, but for planet Earth as a whole. Due to the epidemiological situation, people in many countries are still obliged to observe a mask regime. As a result, in Russia alone, about 10 million disposable masks are now being sent to the trash every day, and it

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