Are you a medical device manufacturer with your eye on the European market? If so, you've probably heard the term "CE Mark". The CE Mark is the key to selling your device in Europe, as all medical devices are required to bear this symbol. However, you can't simply stamp "CE" on your device.
The CE mark certifies that your device meets the requirements of the appropriate EU Directive. Showing your device conforms to these requirements is a complex process with lots of players. In this white paper, we'll answer your biggest questions about European CE Marking, including:
- What is CE Marking and what does it mean?
- Which EU Directives define CE Marking?
- Who are the key players in the CE Marking process?
- What is the Declaration of Conformity?
- What guidances refer to CE Marking certification?
- CE Marking Q&A
Learn all this and more in this 8-page white paper.
About the Author
Elizabeth Pugh: Elizabeth Pugh is a Regulatory Affairs Consultant at Emergo. She has over 15 years of experience with regulat ory affairs in the medical devices industry, and previously held positions at Stryker, FoxHollow Technologies, and DJO Surgical. Her areas of expertise include CE Marking compliance, post-market surveillance, and global vigilance reporting.