After this week you should have a basic understanding of how medical devices are regulated and approved in the EU.

A lot of people say that it is easier to get devices approved in the EU than in the US. Here’s another piece of interesting information: In 2012, I personally visited over 60 different medical device companies and met with at least two other people at each of these meetings. In nearly all of the meetings, the companies told me that they intend to bring their devices to the EU first, and then later to the US, maybe. In late 2014, I did the same thing and got the same results.

Can you make an argument for why it is easier to get devices approved in the EU, knowing what you know now?

Can you make an argument against that? How is this all going to do a complete flip-flop once the new MDD comes out? What will be different regarding how the EU approves devices for use?