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:
Learn all this and more in this 8-page white paper.
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.
自2018年起,美国食品和药物管理局(U.S. Food and Drug Administration,FDA)开始试行以电子化方式来帮助行业提供完整的510(k)上市前通知。2022年,为推进以电子格式提供510(k)递交文件的过渡,美国FDA正式发布关于使用电子递交模板和资源的最终指导文
阅读更多医疗器械和体外诊断(IVD)器械制造商需要获得巴西国家卫生监督局(ANVISA)的认证审批才能在巴西销售他们的产品。
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