With a population approaching a half-billion people, the EU represents arguably the most lucrative market today. However, before any medical device company can sell in Europe, it must first obtain the CE Mark. The process of obtaining approval to affix the CE Mark to your product differs significantly from the US FDA system.
This presentation covers the basic steps companies need to follow in obtaining the CE Mark, including a discussion about ISO 13485:2003 and how it differs from FDA Good Manufacturing Practices (GMP), issues related to language translation and labeling, creation of a Technical File and how this differs from the FDA 510(k) application, dealing with Notified Bodies, selecting an Authorized Representative and an overview of the costs and timelines involved in achieving certification.
CE Marking: 7 Steps to Getting Started in Europe was recorded on 2007-04-03 and is now available for download at www.fxconferences.com
