The MedTech Europe blog

Archives for ghtf

Getting the timing right for the implementation of changes is essential to ensuring that the new regulations result in a better system for in vitro diagnostics (IVD) rather than a bureaucratic quagmire.  The sweeping changes being made to risk classification will be complex and time-consuming.  The lessons learned from similar overhauls in other markets show… » read more

Posted by MedTech Europe

Proponents of greater regulatory harmonisation and cooperation will have been heartened by FDA chief Peggy Hamburg’s comments at the Advamed 2010 conference on Wednesday 20 October. She was quick to acknowledge that, in a changing world with vastly increased trade, the FDA could not continue to operate on an old-fashioned model designed for a time… » read more

Posted by MedTech Europe

In an ideal world we would have the same rules on devices in each country. As patients, as we live or travel in different countries, we can be confident that should we fall ill, the devices used to help us are as safe as the ones at home. As businesses, we would be confident that… » read more

Posted by MedTech Europe