A new study, published in the BMJ, raises some important questions about the approval process for medical devices in both the European Union (EU) and the United States (U.S.). The most important of these questions is how to balance the desire for early access to devices with proven safety and effectiveness, particularly for those devices that are considered major innovations or “breakthroughs.”

A team of UK and U.S. researchers, led by Thomas J. Hwang and Aaron S Kesselheim of the Division of Pharmacoepidemiology and Pharmacoeconomics in the Department of Medicine at Brigham and Women’s Hospital and Harvard Medical School in Boston, decided to evaluate safety issues related to high-profile medical devices introduced first in the EU with later approvals in the U.S. They searched public and commercial databases for announcements about new medical devices approved in the EU between 2005 and 2010. They identified a total of 309 devices (245 cardiovascular, 36 orthopedic, and 28 neurologic devices). Nearly a quarter (75 of 309, 24%) were classified as major interventions. The majority (206 of 309) of devices identified were approved in both the U.S. and EU, of which 63% (129 of 206) were approved first in the EU.


How the EU and U.S. approval processes differ

In order to understand the importance of the location of first approval, we need to look at the difference in the approval processes between the EU and the U.S. According to the article,

“In the European Union, medical devices are approved by private notified bodies if they meet performance criteria and are likely to be safe, but notified bodies generally do not require evidence of effectiveness for most devices….In the United States…the Food and Drug Administration usually requires prospective clinical trials of such devices.”

What this means is that, in the EU, devices can be marketed if they perform “as intended” and are likely to be safe. Clinical testing may only be required for some high-risk devices. In the U.S., however, high-risk devices must demonstrate reasonable safety and effectiveness in clinical trials before they can be used by patients. Because clinical trials are time-consuming to complete (not to mention expensive), high-risk devices are approved faster, in many cases years faster, in the EU than in the U.S.


Patient safety

[showad block=3]Certainly in retrospect, if a device is eventually proven to be both safe and effective, you might think that patients in the EU had a distinct health advantage over U.S. patients because they had access to them sooner. The problem is many of these devices are later proven to be unsafe or not to work as intended. In fact, this study found that about 77/309 (24%) of the devices were associated with safety issues after they reached the market. When the researchers looked at whether the devices were first approved in the EU as opposed to the U.S., they found that there was a nearly three-fold greater rate of safety alerts and recalls.



Since the Medicine is fond of touting that it is evidence-based, it is disturbing to learn that, among the 75 devices classified as major interventions, pivotal trial results were published for only 37 (49%) with an overall publication rate of 37% five years after approval. How on earth are clinicians and patients supposed to make informed decisions if reliable information is lacking?



The authors say this study,

“provides an important empirical measure of the trade-offs associated with the U.S. and EU frameworks for regulating medical devices.”

I agree. It is a natural experiment that sheds light on the consequences of the two approaches. The problem is knowing what to do about it. Does the EU need to become stricter about evidence of safety and efficacy or does the U.S. need to speed things up. Probably, both of these things need to happen.

And, as the authors conclude,

“Patients and clinicians need access to, and balanced presentation of, the available evidence of the safety and effectiveness of novel devices, as well as clear communication about the evidentiary gaps…[there is an] urgent need for transparency to make truly informed decisions.”

While all of this is getting sorted out, it is crucial that we remember the way patients make healthcare decisions in highly personal. Some will be willing to take the risk of an untested product if they can get it quickly; others may prefer a high degree of safety even if they have to wait years to get the product. This is undoubtedly influenced not only by patients’ personal style, but also the type of medical condition, severity, and prognosis they are facing. Lest we try to craft a “one size fits all” solution too soon, we need more studies like this one to help us understand at a much more granular level exactly what the trade-offs are for what devices and which type of patient.


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