Market introduction of high risk medical devices in the EU vs. US

Mise sur le marché de dispositifs médicaux à haut risque : Europe versus Etats-unisKCE has read for you Frank Hulstaert, Mattias Neyt


This 2012 FDA publication illustrates why a robust clinical evaluation of high risk medical devices is necessary before granting market access. Given the EU legislation is currently still under revision, this message remains topical until today.

At the end of this text we give the link to the full FDA report of 16 pages. Below are some quotes from this FDA report.


“This report examines a series of high-risk devices that were approved in the European Union (EU) on the basis of limited scientific data and were later found to be dangerous or ineffective. Most of these devices were ultimately withdrawn from the EU market, but only after thousands of patients were harmed. In many cases, the device’s risks or ineffectiveness were discovered only as a result of studies conducted for approval in the US.”

“US law requires sufficient valid scientific evidence in humans that high-risk devices are both safe and effective—that is, that they provide a real benefit to patients in actual use, and that their risks are well-defined. In contrast, EU approval is conducted by [mainly] private companies and based on more limited evidence, often without significant studies in humans, that high-risk devices are safe and that they are mechanically fit to perform the job they are labeled to do. There is no requirement in the EU that a high-risk device provide an actual treatment benefit to patients. As shown in this report, the limited testing required in the EU can fail to predict dangerous risks and lack of effectiveness in actual use.”

“A sound approval system for high-risk medical devices should ideally provide two benefits to patients. First, it should make sure that patients receive devices that improve their lives without subjecting them to unnecessary risks. Second, it should provide access to important therapies without unnecessary delay. Because it takes time to produce sound evidence that a device is beneficial and that its benefits outweigh its risks, requiring evidence of safety and effectiveness and providing early access are sometimes in tension. This tension raises questions about the value to patients and society of pre-approval substantiation of safety and effectiveness and of whether producing this evidence as a prerequisite to marketing constitutes an “unnecessary delay.” The US and the EU systems approach these questions differently. US law requires that solid evidence showing the benefits and risks of a high-risk device be weighed before it is widely marketed, while EU law requires far less evidence.”

“In many cases, the dangers of these EU-approved devices were not discovered until the manufacturers had to conduct the clinical studies needed to support US approval of a high-risk device. These scientifically robust studies revealed what the limited studies relied on for EU approval could not:

  • That the testing to show the devices’ technical performance did not accurately predict whether the devices would provide a benefit to patients in actual use; and
  • That patients who received the devices were dying or being injured at higher rates than those patients receiving better-established treatments.

For some of these devices, even the widespread marketing of these devices and exposure of thousands of patients did not reveal their dangers—the dangers were discovered only when the devices were subjected to valid studies in the US. This is because it is difficult to discern the true benefits and risks of a device when there is no control group to make valid comparisons.”


Food and Drug Administration (FDA), Department of health and human services. Unsafe and Ineffective Devices Approved in the EU that were Not Approved in the US. May, 2012.

What is KCE has read for you?


KCE has read for you synthesises a recently published high-quality systematic review or health technology assessment with relevance for the Belgian health system.

The original publication was appraised and contextualised by KCE researchers. KCE has read for you is not based on original research conducted by KCE.

More details on methodology can be found on the KCE website.


This document includes

  • Key findings of the publication under evaluation
  • A contextualisation within the Belgian healthcare system

Not included

  • Recommendations
  • Detailed descriptions


Trustworthy original publication

The methodological quality of the systematic review was assessed with the AMSTAR tool.

Gudrun BRIAT (NL)
Communication Manager for the KCE
+32 (0)2 287 33 54 (FR: 33 48)
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