Julie Omohundro When I transitioned from medical writing to regulatory years ago, I hoped I'd never have to do this again, but, as a scientist, writer/editor, AND a regulatory professional, I just can't walk away from this one.

Would anyone like to tackle the statistics? One of the authors has a PhD in biostatistics, so they might be solid. But this is not a bio-study, so maybe, maybe not. You will want to be very facile with linear and Cox regression models, or I think this will be too time-consuming as something to do on a volunteer basis. You will also want to ask yourself if you will be willing to stand by your critique in a letter to the BMJ editor, if one seems warranted.

CEO -Shuky- Liat Nadel-Isr.Reg.Holder New EU regulations .Let's see...

Girish Srinivasan, PhD I am looking forward to read this publication. I definitely agree that it is a generally easier to get CE approval than FDA. Typically companies plan their product roadmap to first get CE approval for their solution or device and use the data / evidences gathered towards FDA submission. In my experience, I have noticed that the FDA submission requirements are very well documented. It was a little more challenging to get a general EU guideline. This may be because each country in EU might have their specific guideline published in a local language. But it might be useful to see generic CE guidelines more easily accessible.

Also I believe there would be a great value add in having a unified platform to collect and document evidence required for any regulatory submissions. This will help minimize any ambiguities.

Anyone are of such an existing solution or may be an effort to create one?

this may be a true statement - but what´s with the risk of not having a medical device on the market because the hurdles are to high to bring it to that market. Each medical device should rather undergo an individual risk-benefit evaluation than a pre-defined assessment. You will never be able to simulate the on-market behaviour and - in most cases you have doctors who are educated to make decisions in regards to their patients safety.

MDSAP will make a definite shift here.

Statistic seems too high, but I believe the general trend:

Having CE Mark can create external and internal pressure on FDA to move more quickly to clear a product and avoid a gap in available tech between EU and US. This pressure may result in a less robust review.

Companies rushing to market might go to the fastest-to-market major market available (EU). The rush to market may also have affected internal design and quality reviews.

Finally, for some companies, EU (and other CE countries) may be their home market, but these are not the biggest companies in medical device and they may not have the most sophisticated quality systems.

Julie Omohundro For those that haven't read the article, and are just responding to the title of post...as far as I can tell, the article isn't actually about it being easier to get CE marked than to get FDA clearance.

Robert Christensen I found the CE Mark was much more reasonable, less
costly and much quicker. Esp. for a device that was
pre-ammendment and in commercial use for forty years.

Julie Omohundro I'm still slugging my way through the article, but the authorship is interesting.

None of the authors seem to have any training or experience in the area of medical devices or device regulation, nor have any of them ever worked for a medical device company regulated by either FDA or the EU, nor do they seem to have any other qualifications appropriate to the topic.

The senior author lists his affiliation as "Faculty of Arts and Sciences, Harvard University," but neither his LinkedIn profile nor the profile on his personal website indicate that he was ever on any faculty, nor that he was ever affiliated with the College of Arts and Sciences at Harvard. In his LinkedIn profile, he describes himself as a healthcare researcher and investor, and as having been employed by the Blackstone Group and Bain Capital Ventures.

Julie Omohundro The main finding was that devices approved first in the EU were associated with a nearly threefold greater rate of safety alerts and recalls, compared to those that were approved in the US.

The study also found that (510(k) devices received market clearance from the FDA an average of one month earlier than they were CE marked in the EU.

Julie Omohundro And that PMA devices were approved an average of 38 months after CE marking.

Marie Suetsugu This is a recurrent theme isn't it... In my experience 510(k) clearance, for which the quality system audit isn't required beforehand, was easier than Class IIa CE marking certification. So it keeps surprising me that there are actually people feeling otherwise. Perhaps it just depends on the classification of your device?

Julie Omohundro Marie, it probably depends more on which crowd you hang out with. It's a theme that serves various interests here in the US.

Marie Suetsugu In fact...it seems to me to be voiced more by Americans (or people based in the US).