Since the COVID-19 pandemic hit, there has been an unprecedented demand for personal protective equipment (PPE). The use of PPE by medical professiona...
EU MDR: What to Do if Your Company Is Unable to Comply by the Deadline
Will your products be compliant with the European Union (EU) Medical Device Regulation (MDR) when it takes full effect on May 26, 2020? Since the intr...
The Scope of the EU Medical Device Regulation
The European Union (EU) Medical Device Regulation (MDR) is due to take full effect in May 2020, and its new scope includes a large number of products ...
Understanding Section 10.4.1 of the EU MDR
After a three-year transition period, the European Union (EU) Medical Device Regulation (MDR) 2017/745 is set to take full effect on May 26, 2020, rep...