EU MedTech Forum 2022: Regulatory Unpredictability Spurs Renewed Calls For Devices Agency
In the EU, lack of regulatory predictability is creating frustration, sending innovators across the Atlantic, and has been a factor in calls for a devices agency. MedTech Europe’s Oliver Bisazza and BVMed’s Marc Pierre Möll reviewed the top concerns aired at the MedTech Forum in early May.
You may also be interested in...
Neovasc’ COO Bill Little talked to Medtech Insight about the company’s plans to develop its Reducer transcatheter device to treat cardiac angina associated with or without obstructive coronary disease.
Originally intended to increase medical device safety, the EU’s medtech regulation is so hampered in its implementation that it is now arguably a bigger potential threat to patients than any of the scandals leading to its more stringent requirements.
EU member state authorities overseeing devices have been putting out a series of messages that promise action to ease the implementation chaos surrounding the EU’s new medtech regulations.