MedTech Europe, the alliance of European medical technology industry associations, is launched today at the European MedTech Forum in Brussels. Founded by the European Medical Technology Industry Association Eucomed and the European Diagnostic Manufacturers Association EDMA, the alliance will collaborate closely on common policy interest areas and welcomes other European medtech associations to join. MedTech Europe will be legally established by the end of 2012.
The recent PIP breast implant incident has made it crystal clear that healthcare actors must pull together to ensure that such a case of fraud never happens again. The medical device industry unanimously agrees that an overhaul of Europe’s regulatory framework is necessary to improve the system that has been the world’s fastest in providing life-saving technologies to patients without compromising safety. The European industry association Eucomed welcomes most of the recommended measures in the European Medical Device Directive proposal but voices strong concern with regards to the ‘scrutiny procedure’ as it will ultimately harm patients and will negatively impact European governments and industry.
The US FDA's premarket authorisation system for regulating high-risk medical devices not only delays patients' access to potentially life-saving technologies but does not safeguard them against risky products any more than the EU's CE marking process.
Moreover, it has a detrimental impact on small companies with limited resources which could cause these companies to stop operating, to the detriment of the development of innovative technologies in the US.