Are you thinking of marketing your medical device in Europe? If so, you must write and maintain a clinical evaluation report (CER) as part of your Technical File submission. The EU Directives emphasize the importance of the CER and include specific requirements for clinical evaluation review and documentation. They also require you to maintain your CER even after you receive your CE Marking certificate.
The clinical evaluation report is a key component of the CE Marking process so it's important to get it right. In this white paper, we answer your biggest questions about drafting and conducting a comprehensive CER, including:
- What is a CER?
- What are the steps for writing a good CER?
- What are critical steps and pitfalls to avoid?
- How to update your CER post-CE marking?
Download this 4-page white paper for answers to all these questions and more.
About the Author:
Jaap Laufer M.D., PharmD is Vice President of Clinical & Regulatory Affairs with Emergo.