Print Edition - Medical Device Adverse Event Reporting: A Guide to EU and US Premarket and Postmarket Compliance

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June 2011
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If a user discovers a deficiency in a device prior to use, does it have to be reported in the EU? How about the US?

In the EU, do you need to report adverse events to the competent authority where the event occurred, where the device was made, or both?

If an adverse event takes place involving a medical device made in the US, but the device is not available for sale in the US, must it be reported to the FDA?

If you don’t know all the answers, you’re not alone. The adverse event reporting requirements for medical devices in the US and the EU are riddled with confusing scenarios. It’s true that the rules attempt to accomplish the same goals, but the details offer huge potential for mistakes.

Don’t let US-EU differences expose you to noncompliance. Here’s how to master both sets of rules.

This resource pulls together what medical device companies need to know about how the FDA and the European Medicines Agency (EMA) rules are similar — and how they differ — all in one convenient volume.

Step by step, you’ll gain a thorough understanding of your pre- and post-market reporting responsibilities in both markets, as well as real-world tips for maintaining AE reporting systems that satisfy both sets of regulations.

Buy now to get the clear, practical guidance you need to align adverse event reporting processes and audit suppliers, including:

  • A plain-English overview and explanation of the EU
    and US approaches
  • Who must report adverse events
  • Who receives adverse event reports
  • Timelines for reporting
  • Common events that do not need reporting in the US,
    EU or both
  • Practical considerations for implementing compliant
    MDR and EU vigilance systems
  • EMA guidelines and FDA guidances that are essential
    to understanding reporting obligations

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