May 22, 2012

A new report issued by the US Food and Drug Administration argues that the European Union's regulatory system fails to ensure safety of high-risk medical devices it approves.

Citing 12 examples of high-risk devices approved in the EU and then later deemed ineffective or dangerous, the FDA report contends that EU regulators require less clinical evidence of device safety than the EU medical device approval requirements focus too heavily on technical performance rather than safety.

The use of Notified Bodies in the EU medical device review process also comes under fire in the FDA report, particularly the following issues:

  • No centralized oversight of Notified Bodies
  • Approval of a device by any single Notified Body enables marketing throughout the EU
  • No publicly available evidence of Notified Bodies' approval decisions
  • No centralized collection of data related to device side effects

EU post-approval reporting requirements for device safety issues are often too limited to be effective, according to the FDA, making it more challenging for interested parties to obtain data necessary to determine a device’s safety or effectiveness.

High-risk devices the report mentions as having been approved in the EU and then removed from the market include Trilucent breast implants, abdominal aortic aneurysm (AAA) stent grafts, elbow implants and cardiac constraint device technologies.

While the new report will further fuel arguments between US and EU medical device regulators in terms of which system more effectively protects patient safety and fosters innovation, the FDA’s report no doubt also targets US industry groups arguing that the US device review system needs to be more like that in the EU.


  • Stewart Eisenhart