In light of the health care product supply challenges during the current pandemic, the European Parliament and the Council of the EU have reached a provisional agreement on the European Commission’s proposed Regulation for a reinforced role for the European Medicines Agency in healthcare crises.
The document lays out the new role the EMA would play in overseeing various aspects of device management, as well as medicines, in the event of a health care crisis....
There are 198 mentions of the word “device” in the original commission proposal an indicator of the extent to which the commission foresees the European medicines regulator playing a new...