Despite years of harmonization talks, the EU and US still follow very different marketing approval processes for medical devices. And when the EU's MDD went into effect in 2010, those differences became more pronounced.
- Failing to know the differences could critically handicap your time to market and ability to operate efficiently.
- Failing to comply with those differences could shut you out of EU markets completely.
FDAnews Management Report
Medical Device Regulation in the EU vs. US:
Recent Revisions and Key Differences
EU and FDA regulators continue to apply different sets of requirements for medical device market approval, despite longstanding attempts at harmonization.
Do you understand how CE marking, PMA approval and 510(k) clearance processes differ? Are you prepared for the impact of recent major revisions to the EU Medical Devices Directives?
Here's how to make sure you're fully informed — and in compliance.
With this new FDAnews management report, you'll get practical guidance on exactly how recent revisions and key differences in both sets of regulations affect your market access.
In particular, you'll benefit from a sharp, current look at the real-world impact of recent revisions to the EU Medical Devices Directives, including new clinical trials and clinical evidence requirements, new notification requirements for changes in devices, and expanded definitions that now include software used in device development as a medical device.
Buy now to be ready for the regulations you'll face as you bring medical devices to market, including:
- Key differences between the EU and US marketing approval processes
- How CE marking, PMA approval and 510(k) clearance processes differ
- How US Class I/II/III categories differ from EU Class I/IIa/IIb/III categories
- Which medical devices are subject to vastly different restrictions in the
EU compared to US requirements
- How to plan for the roles played by authorized representatives, competent authorities, notified bodies, and US regulators
- Recent revisions to the EU MDDs, including major changes plus a host of lesser changes that can cause costly delays and even market denials
- And much more
You can depend on this new FDAnews Management Report to help you get your medical devices into both US and EU markets — without risking noncompliance nightmares in either.
Medical Device Regulation in the EU vs. US: Recent Revisions and Key Differences is offered by FDAnews in print or PDF format for $377. Act now: place your order here. (Add $10 shipping and handling per book for printed books shipped to the U.S. and Canada, or $35 per book for books shipped elsewhere. Virginia residents, please add 5 percent sales tax.)
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