The FDA is often criticized for stifling innovation and lagging device approvals. Due to this, many manufacturers are looking overseas because of these regulatory challenges by the Food and Drug Administration. According to a survey funded by the Institute for Health Technology Studies, medical device companies (263 out of 350 or 75%) are pursuing approval for their products overseas first. The difference in delay between the United States and the European Union is 1-3 years and probably because the regulatory process in EU is more efficient and predictable. Also important to note that the FDA requires evidence of safety evidence that the device performs consistently to the manufacturers use as compared to the CE Mark that only requires proof of safety. But is it always worth seeking approval overseas (for Americans)? Companies must determine their regulatory strategy to minimize their risks. In efforts of faster approval times and more predictability in Europe, a manufacturer still isn’t guaranteed that the device will be widely accepted for the physicians in the European countries. If time is of the essence, then seeking approval in Europe is the way to go but that will not guarantee overall success of the product.

From my experience, the company that i work for proceeded with releasing their medical device which is a vision testing device for diagnosis and early detection of retinal pathologies. The device was first submitted to obtain a CE Mark and released after following the checklist associated to the MDD (Medical Device Directive). This device is considered a Class IIa since it is a device that measures electrical impulses produced by the visual cortex and retinal cells. The EU procedure in getting a medical device approved is much easier and as a buisness standpoint, far better considering it opens the market to sell the device in the rest of Europe. Comparing this to the FDA's standards and requirements, the process would be much longer and cumbersome since this same device would be considered a Class II and require a 510K since it is working from a predicate existing technology and device in the market. Following the 510K requires an extensive procedure to follow, this is because the FDA heavily focuses on the safety and efficacy of the device and the patient's well being.

It is easier to get devices approved in the EU than FDA:
1- FDA approval always requires a full clinical trial or trials, whereas the CE Mark in EU can be obtained through a clinical evaluation,a review of published data for existing equivalent devices.
2- The documentation required from investigators is much less efficient for FDA submissions than it is for the CE Mark.
3- The CE Mark is recognized almost globally, in addition to being valid in all countries of the European Union. By comparison, FDA approval is valid only in the United States. For this reason, it is more attractive to companies to apply for the CE Mark first.
4- Allows new technology to more quickly become available to patients compared with the FDA approval system (shorter time).
5- In EU For approval by a Notified Body (NB), devices are subject to performance and reliability testing linked to the risks of their intended use.
So, it is easier to approve a medical device in EU than FDA, however the good thing in FDA is that the FDA approves every step of the process that is required for a medication or surgical device to be used clinically, and it bases its approvals on the outcomes of large clinical trials and strict clinical evidence and outcomes. FDA approval indicates that strict criteria have been met, and that clinical application of a drug or device will be safe and effective. But in EU, CE mark leaves safety and efficacy of the surgical procedure that is performed by the device to the responsibility of the physicians and surgeons who use the device.

It is easier to get device approval in EU than FDA.Regulatory process is less bureaucratic ,more efficient and more predictable than FDA.FDA requires both safety and efficacy of a device and it is becoming more difficult to conduct clinical trails in th U.S.due to FDA’s clinical data requirement .CE only require proof of safety and device performs in a manner consistent with manufacturer intended use..Timeline for obtaining CE mark is shorter than timeline for gaining FDA approval.FDA has the advantage of centralization and common rules,European union regulates medical drug and device approval through a network of centralized and decentralized agencies throughout its member state.

It is apparent that it is easier to have a medical device approved in the EU versus in the US, possibly due to the simplified yet still effective method of approval. Where the FDA takes into consideration devices being safe and effective, the EU focuses primarily on the risk factors. Whether it is effective is not a necessary criteria as it is with the FDA. In addition to the points that have been aforementioned, the separation of types of medical devices even before the more specific classifications creates a more manageable system in terms of approvals.

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

Based on this weeks lecture the EU regulatory focuses on risk and essential requirements checklist. The FDA analyzes more so on efficacy and the FDA makes the sole decision on if the medical device meets the regulations. EU regulatory is split into:
1. Competent Authority: Similar to the FDA but each country has their own Competent Authority. Unlike the FDA the Competent Authority does not complete audits or inspections. The Competent Authority proposes rules for the EU to vote on. Their main priority is analyzing the risk of the medical device.
2. Manufacturer: They make the medical device and hold the final responsibility of the device.
3. Notified Body: These are private companies that are contracted by the EU to inspect and audit manufacturers for the Competent Authority.
Competent Authority knows that the manufacturer of the medical device meets the audit and inspection criteria based on the CE mark placed on medical devices. If it is approved in one country, then it is approved in all European countries. That is not how the FDA works. The FDA has the right to audit and inspect manufacturers directly. The FDA does not base their decisions solely on risk or an essential requirements checklist. The regulatory pathway of the FDA is much more picky and specific in terms of classification and design controls. Therefore, I would agree with many of my peers that a medical device is easier to have approved in the EU then USA because of the FDA regulatory breakdown.

In the US, the approvals for medical devices are done by the FDA. The FDA approves the device for the whole country, and has the ability to inspect and audit. In addition, they have the authority to take products off the market and even shut down companies if they find necessary. As a result, in the US, it is very difficult in getting the approval of medical devices. In the EU, the EU Regulatory and Government bodies determine the regulations for all the countries. When a device is approved in one country, then it is approved in all EU. There are the Competent Authority, Manufacturer, and Notified Body in approving the medical devices in EU. Depending on the document filled, the approval of the device is given.

My answer is maybe not. Other than the lecture video, I have limited area about this topic so I did a search on it and found some interesting information. From the lecture, various reasons you guys have mentioned and various articles you guys have pointed out I would say that it's easier to get approval in EU than in the US. However I came across some articles that pointed out that despite the assumption that drugs/medical devices are approved more slowly in the United States, analysis showed that they actually reach the public faster in the United States than Europe (S.A. Roberts, "Despite critism of the FDA review process, new cancer drugs reach patients sooner in the United States than in Europe"; S.Basu, "Patient access to medical devies-a comparion of US and European review processes"). Furthermore, ccording to Kramel et al., as of 2010 devices approved via the FDA 501(k) approval process only lagged behind EU approval by 18 days (D.B.Karmer, "How does medical device approval regulation perfom in the United States and the European Unnion? A systematic review").

There is a good article from ScienceDirect with a comprehensive review about the European and US Approval Processes for Drugs and devices by Gail A. Van Normal in 2016 (somehow I can't paste the link)

I found this article that relates to the topic. It digs a little deeper as to WHY it actually takes so long go get devices approved in the US. According to the article, Innovative medical devices take significantly longer to gain approval from the U.S. Food and Drug Administration because of administrative hurdles, rather than unfamiliarity with the new devices.
“Pioneer, first-generation medical devices in a particular category took 7.2 months longer to gain FDA approval (34 percent) than the first follow-on device, while most follow-on drugs take about 10 days (1.2 percent) longer to approve than the original drug in their class, the study found. This means that cutting-edge drugs are getting through the FDA red tape faster than groundbreaking medical devices are.”

Additionally, the article highlights challenges that factor into the delay such as:
• Little guidance from the FDA about what they need to provide in clinical trials for novel, potentially high-risk devices. For most devices, the evaluation criteria that the FDA will use to assess a new product are not made explicit before the regulatory process begins
• Devices are less likely than drugs to have demonstrated clinical safety before they go to market. In a 2009 review published in the Journal of the American Medical Association, University of California-San Francisco cardiologist Dr. Rita Redberg and colleagues found that 65 percent of FDA pre-market approvals for cardiovascular devices were based on a single study. 27 percent of studies used to support recent FDA approval of cardiovascular devices were randomized and just 14 percent of them were blinded. Unrandomized, unblinded studies have significantly greater potential for bias.

http://www.washdiplomat. com/index.php?option=com_content&view=article&id=12344:too-slow-or-too-sloppy-medical-devices-want-faster-fda-approval&catid=1535&Itemid=428

Clinical data required for premarket approval is a significant difference in time-to-market approval in EU and US. Medical devices in the EU is regulated by three directives. The main directive being Medical Devices Directive (MDD). These three directives have been enacted into the national laws of each EU state, resulting in a legislative framework comprised of literal dozen of medical device laws. The medical device my group is working on now has a CE mark. CE marking is the medical device manufacturer's claim that a product meets the essential requirements of all relevant European Medical Device Directives. Which means that this medical device bearing a CE marking can circulate freely throughout the EU without any barriers. Making it easier for it to go to market in Europe before coming to the US.