EU industry kept waiting on German device risk upgrade plans
This article was originally published in Clinica
There has still been no formal request from the German authorities for a reclassification of several groups of medical devices that they wish to see in a higher risk category.
You may also be interested in...
The Pink Sheet explains the procedures underpinning the UK’s emergency use authorization of the Pfizer/BioNTech COVID-19 vaccine.
The US Food and Drug Administration posted two device-related closeout letters in November.
Jazz and PharmaMar need to see what further data will be needed to convert their FDA authorization into a full approval following disappointing results in the ATLANTIS Phase III trial.