Preparing a European CE Technical File for a Medical Device
Questions? Request more information from our specialists
CONTACT US
Want to sell your medical device in Europe? If the answer is yes, you probably have a lot of questions about one of the key elements of the European regulatory process: the CE Technical File.
Preparing your CE Technical File takes precision and care, as the requirements for data, documentation, and formatting of this document are very specific. In this white paper, we demystify this important document and answer your biggest questions about how to prepare a Technical File, including:
- How does the Technical File fit in the CE Marking process?
- What are the common elements of a technical file?
- What are the harmonization formats for technical files?
- What is a clinical evaluation report (CER)?
- What is the Declaration of Conformity (DoC)?
We answer all of these questions and more in this 8-page white paper.
About the Author:
Evangeline Loh, Ph.D., RAC (US/EU): Evangeline is Vice President of Global Regulatory Affairs at Emergo. Evangeline's areas of expertise include European CE Marking, clinical evaluation reports, vigilance, and device classification in markets worldwide. She previously worked for Cook Medical and holds a Ph.D. in pharmacology from The University of Texas Health Sciences Center at San Antonio.
Related
-
WATCH NOW: Risk Management according to EN ISO 14971:2012
Since the publication of ISO 13485:2016, risk management is a major concern for maintaining regulatory compliance in major medical device markets.
read more -
WATCH NOW: How to Select or Change Your EU Notified Body
European Notified Bodies are under intense scrutiny by Competent Authorities, and that oversight has filtered down to their clients. A few years ag
read more