In vitro diagnostic medical devices (IVDs), hence devices used for medical tests on samples such as blood or tissue that have been taken from the human body, have become the center of attention in the public eye during the...more
5/31/2022
/ Certifications ,
Classification ,
Coronavirus/COVID-19 ,
Diagnostic Tests ,
EFTA ,
EU ,
European Commission ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Software
The European Union (“EU”) and its Member States are struggling with the pace of their vaccination programs. This is partly due to shortages of vaccine availability. Germany, like the rest of the EU, is scrambling to obtain...more
3/2/2021
/ Compensation ,
Coronavirus/COVID-19 ,
EU ,
Germany ,
Infectious Diseases ,
Liability ,
Ministry of Health ,
Patents ,
Supply Shortages ,
Third-Party ,
Vaccinations
In Part 2 of our series of consecutive articles on the reformed regulatory framework under the EU Medical Device Regulation 2017/745 (“MDR”), which will soon govern medical devices software (“MDSW”) in the EU, we will shed...more
The COVID-19 pandemic has significantly accelerated the adoption of digital health and virtual care in Europe, as well as globally. Fueled by technological advancement, including in the space of data analytics and AI, this...more
As the COVID-19 pandemic continues to spread globally, the life sciences industry is at the forefront of addressing the urgent need for pharmaceuticals, diagnostics, ventilators, and personal protective equipment capable of...more