Cracking the European market for your medical device or in vitro diagnostic device can be a long and complex process.
And companies tackling EU legislation for the first time - such as start-ups or non-European organizations - can be led astray by common myths and misconceptions.
What do Class I devices actually require? How do EU requirements compare to non-EU territories, such as Switzerland? What does good post-market surveillance really look like?
We’re tackling confusion, myth and FAQs to give you a clear and sensible pathway that gets your device through the doors and into Europe.