Over the years, a growing number of medical device companies in the United States have decided to obtain the CE mark for new products before attempting to approve products through FDA. While FDA is not monolithic, many in the industry view the European system as generally more consistent, transparent, and often easier to deal with than FDA’s Office of Device Approvals. And the reason for that thinking is easy to understand: products generally obtain the CE mark much earlier than they do FDA approval.
In late 2010, a somewhat controversial survey titled “FDA Impact on U.S. Medical Technology Innovation” sought to quantify the feeling of medical device professionals in the United States who had experience with product approvals in the United States and Europe. In terms of “overall experience,” the survey found that 75% of respondents rated their regulatory experience in the European Union as “excellent” or “very good.” Only 16% held FDA in such high esteem.
But the fact remains that many people active in the industry had the opinion that the European regulatory framework was, in a word, better than the US version. In early 2011, Jeffrey Shuren, MD, director of FDA’s CDRH division came to the defense of the US regulatory system, stating that, in the EU, patients are treated as “guinea pigs.”
His remark was widely attacked at the time. But, more recently, there has been growing disapproval of the EU system as a result of the PIP breast implant scandal.
Over on the Medical Devices Group, I asked if a CE mark was “good enough,” and 67 responses came pouring in within two weeks. I wrote:
As you know, medical devices sold in America require FDA clearance. Is gaining FDA clearance more stringent than obtaining a CE mark?
And a question for regulatory experts in our group: Is it defensible for your sales reps to say to a prospect, “Well, our device has FDA clearance and the competitor only has a CE mark.” The clear inference is that FDA clearance is better, so you should buy my product instead.
|Michael Olmsted, an experienced VP of field services for medical device companies, taught me I was comparing apples and oranges. “As a US-based manufacturer, we didn’t compare CE and the FDA but whether your equipment was UL (Underwriters Laboratory) certified and then CE approved to be sold into Europe.” Ben Vonk added, “CE is not a mark (like the UL mark) but rather a marking. So it is better to talk about CE marking a product.”|
|Medical Device Regulatory Affairs Expert Michael Santalucia squarely answered my question. He opined, “I wouldn’t necessarily state that FDA is better than the EU process – rather it is different based on law and other requirements … As to the question of a marketing use to compare approvals between jurisdictions … it may not be the best practice to state having authorization to market in one or multiple countries is an indicator of quality or performance.”|
|Leslie Gestautas, an EU notified body, sides with Michael. “Comparing the two systems in an apples-to-apples or which-is-better scenario is a fast road to frustration (this is true outside of MDD and IVD as well – CE doesn’t compare directly to UL for other types of manufacturers, for example).
I’m not aware that a marketing claim like the one you came across could get you into “trouble” per se, but as a former entrepreneur myself I think it’s a weak marketing stance, and at worst it broadcasts a clear misunderstanding of the two types of clearance (FDA and CE). I’d want a lot more for my marketing dollar than that!
Sounds to me like their regulatory dept. was doing a good job by nixing that approach.”
|Uffe Kemnitz promotes high-end ophthalmology products. Uffe wrote, “I have worked with medical devices for many years. My experience is that the FDA at any time will rank higher than the CE marking. Although within the EU must not use the FDA as a standard, many doctors [ask] ‘What does FDA say for this device?’
What I think is ludicrous is you can not agree on creating a common labeling and thus a common set of rules for approval of products for both the EU and the U.S.. It is tremendously expensive to pay for studies at one and the other to the Atlantic.
EMEA and FDA on the medical side Santander are often unaware of each other’s results so companies to get access to one or the other market are forced to spend much money on documentation to satisfy the bureaucrats in both institutions. It would be worthwhile to work towards a common label.”
|Jean Bigoney prepares 510(k) submissions and HCPCS coding requests for a variety of medical devices. She wrote, “FDA clearance is indeed far more cumbersome than getting the CE mark.
I’ve run into several medical device manufacturers and startups in Europe blindsided by the requirements for a 510(k) but also baffled as to how our system works … they usually do not understand the FDA is reactive and not proactive, and only responds to issues pertaining to specific products. So to use the FDA approval process as a marketing argument in Europe could be difficult – your audience may have no idea what the approval process entails.”
Jean continued: “Having said that, there may be an opportunity to use the current breast implant scandal to play up the positive side of FDA regulatory authority. Make no mistake, someone determined to substitute inexpensive non-approved materials for costlier approved ones could get away with it in the US, at least for a limited period of time. However I like to think that sooner or later, they would be on the FDA radar. As a matter of fact, in the case of PIP, the FDA inspected the manufacturing site way back in 2000 in connection with a different type of breast implant and as a result sent PIP this warning letter.
If the FDA knew way back in 2000 that PIP had GMP manufacturing issues, why didn’t the EU regulatory system pick up on it?
|Norbert Sparrow, EMDT Editor-in-Chief, added, “I do believe that the European regulatory system will become stricter, partly to respond to public concerns of device safety in the aftermath of the PIP implants scandal as well as other perceived shortcomings of the “new approach” directives … Will the “Europe first” strategy that many medical device manufacturers have embraced be a casualty?”|
The LinkedIn conversation is robust, ongoing, and larger than is practical to summarize here. Click over to the discussion and add your voice.
Special thanks to UBM Canon editor-at-large Brian Buntz for his help with this article.
Joe Hage is the owner of the largest Medical Devices Group on LinkedIn. His LinkedIn goal is to create the industry’s only spam-free, curated forum for intelligent conversations with medical device thought leaders. As CEO of Medical Marcom, a medical device marketing consultancy, Joe helps companies become more approachable and engaging so they can generate more qualified leads.Joe Hage