It used to be that medical device companies could bring a device to market in Europe long before gaining FDA clearance in the US.
It was fun while it lasted, but unfortunately, those days are long gone.
The last five to ten years have ushered in drastic changes in the European standards, thanks to an unfortunate breast implant debacle in France.
The company falsified a few documents and failed to do any biocompatibility testing, eventually costing the French government over $60 million dollars.
AND the notifiying body was sued as a result.
Not a great way to instill faith in your product, or your company. Or healthcare system, for that matter.
So, the European authorities implemented tougher standards, just as the FDA was broadening their acceptance of consensus standards, opening new pathways for international devices to be approved for sale in the US.
Talk about ships passing in the night.
So now it can be even more difficult to determine which standards apply to a device looking to launch in Europe and the US. I can help you decipher the regulations, so put some time on my calendar and let’s create a regulatory pathway that is right for you.