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 Regulatory & Clinical Affairs at Emergo. Dr. Laufer has over 30 years of experience in the medical device and pharmaceuticals industries. He previously held executive and senior regulatory positions at Pfizer, Abbott Laboratories, LipoMatrix, and others. His areas of expertise include a vast array of mostly implant and higher classed products, ISO and FDA QSR audits, and clinical study approvals and compliance. He holds a PharmD in Pharmacy from the University of Groningen and is an MD from the Medical School of the University of Nijmegen, both in The Netherlands. Dr. Laufer is a member of the Medical Devices Expert Group to the EU Commission and