European Commission responds to "easy market access" claims
This article was originally published in RAJ Devices
Executive Summary
The European Commission is unable to say whether market access for medical devices is easier in the European Union than it is in the US, as has been suggested1,2. Any comparative advantage of the EU with regard to easy market access that does exist, however, will “slightly shrink” when new requirements for clinical investigation become effective, the commission says, adding that there is nothing wrong with easy access as long as it is not linked to a low safety standard.