I agree with the posts mentioned above. Device companies have been seeking early approval in Europe for years because it is easier. I think the two main differences that make it easier to get approval in Europe are:

1. In Europe, a device needs to be determined safe, while in the US, it also has to show that its effective in treating a disease or condition
2. European approvals are handled by third parties, not a central agency like the FDA.

If found a study published in 2016 that looked at over 300 devices and found that cardiovascular, neurologic, and orthopedic devices first approved in the EU are nearly three times more likely to be subject to safety alerts and recalls than those first approved in the US. It also mentions a transcatheter aortic-valve replacement, which was approved for symptomatic aortic stenosis in the EU in 2007, 3 years before its effectiveness was established in a published randomized trial and 4 years before gaining US approval.

The FDA doesn’t want Americans to be seen as guinea pigs, but the argument can be made that American patients are being deprived of the latest technology because companies routinely seek approval for new devices in Europe first. For example, heart valves installed through a catheter instead of open-heart surgery have been available in Europe since 2007 but weren’t available in US until 2011.

I think this shows that just because a way might be easier, it may not always be the best way. You wouldn’t want to get a faulty heart valve and then have to get another surgery. On the flip side, this “easier” process does allow for medical products to reach patients faster and if adequate testing is done, could be life-changing like the heart valves installed through a catheter. I think there has to be a balance between getting medical devices on the market quickly while also having effective quality products for patients.

nytimes2011/02/10/business/10device.html
medscape/viewarticle/866341#vp_2