European Parliament Gives Final Go Ahead To EMA’s New Roles In Devices Oversight
The new EU regulation on increasing powers of the European Medicines Agency in future health crises applies as of 1 March; it controversially sees the agency become more involved in device oversight.
You may also be interested in...
Industry opposes the proposed new role of European Medicines Agency in overseeing devices availability in a healthcare crisis. But a new Regulation may be adopted in March and its fallout looks set to herald a new era for device supply management and regulation.
The medtech industry has long resisted having the European Medicines Agency involved in device oversight. Now an EU-level proposal is making device makers nervous.
Amending the MDR to stem the flow of medtech products being withdrawn from the market has long been seen as urgent. It looks like the EU is keeping its foot on the accelerator to adopt its latest proposal despite concerns raised about the text.