Recruiter's Glossary

Examples: PMA • DHR • Shelf Life Studies

CER

Term from Medical Device Manufacturing industry explained for recruiters

CER (Clinical Evaluation Report) is an important document required for medical devices in Europe. It's like a comprehensive safety and effectiveness report that proves a medical device is safe to use and does what it claims to do. Think of it as a detailed story about the device that includes all the evidence showing it's safe for patients. Companies need these reports to legally sell their medical devices in European countries. Similar terms you might see are "Clinical Evidence Report" or "Clinical Assessment Report."

Examples in Resumes

Led team in preparing and maintaining CER documentation for Class III medical devices

Updated and reviewed Clinical Evaluation Report for regulatory compliance

Managed multiple CER submissions to European notified bodies

Typical job title: "Clinical Evaluation Report Writers"

Also try searching for:

Medical Writer Regulatory Affairs Specialist Clinical Evaluation Specialist Medical Device Documentation Specialist Clinical Evidence Writer Regulatory Compliance Specialist

Where to Find Clinical Evaluation Report Writers

Professional Organizations

Job Boards

Professional Networks

Example Interview Questions

Senior Level Questions

Q: How would you handle a CER for a high-risk medical device with limited clinical data?

Expected Answer: Should explain strategies for gathering alternative evidence, such as using similar device data, literature reviews, and post-market surveillance. Should mention risk management and how to justify safety and performance claims.

Q: How do you ensure a CER meets the latest MDR requirements?

Expected Answer: Should discuss keeping up with regulatory changes, understanding MEDDEV guidelines, maintaining proper documentation structure, and ensuring regular updates to meet European requirements.

Mid Level Questions

Q: What are the key components of a CER?

Expected Answer: Should identify main sections like device description, literature review, clinical evidence evaluation, risk analysis, and conclusions about safety and performance.

Q: How often should a CER be updated and why?

Expected Answer: Should explain the regular update schedule based on device risk class, importance of including new clinical data, and responding to safety concerns or regulatory changes.

Junior Level Questions

Q: What is the purpose of a CER?

Expected Answer: Should explain that it's a document proving device safety and effectiveness through clinical evidence, required for selling medical devices in Europe.

Q: What types of information do you need to collect for a CER?

Expected Answer: Should mention clinical studies, published literature, complaint data, and similar device information that helps prove safety and performance.