Adverse Event Reporting: A Global Look From Pre- to Postmarket

As fallout from the defective PIP breast implant imbroglio continues, a European Parliament health committee is calling for tough new regulatory controls, including the creation of a premarket authorization system for certain categories of medical devices — an idea that brought immediate kickback from industry.

In a unanimous resolution April 25, the Committee on Environment, Public Health and Food Safety also urges strengthened postmarket surveillance and safety controls, better coordination of adverse event reports and systematic access for notified bodies to such reports. Frequent, unannounced inspections of device plants by local authorities, enhanced controls of notified bodies and more sample testing of products already on the market are also needed to ensure the safety of devices in the EU, the resolution states.

The resolution also urges frequent, unannounced inspections of device plants by local authorities, enhanced controls of notified bodies and more sample testing of marketed products.

Whether you’re across the pond or stateside, the adverse event reporting requirements for medical devices in the U.S. and 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 U.S.-EU differences expose you to poor compliance. With FDAnews’ Medical Device Adverse Event Reporting: A Guide to EU and US Premarketing and Postmarket Compliance you can master both sets of rules.

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

Don’t wait, order your must-have copy today!