The Clinical Evaluation Report (CER) is a cornerstone of CE registration under the Medical Device Regulation (MDR), providing a detailed assessment of a medical device’s safety and performance.
Preparing a robust and compliant CER demands in-depth knowledge of regulatory requirements and scientific principles. It involves a meticulous, transparent, and well-documented process that critically evaluates clinical data. Collaboration between manufacturers and clinical experts is vital to ensure the quality, relevance, and traceability of the data, as well as the scientific validity of the literature review.
Notified Bodies place significant emphasis on:
✅ The sufficiency of clinical data.
✅ The demonstration of clinical benefits.
✅ The acceptability of the benefit-risk ratio.
Moreover, the CER must be continuously updated with new clinical data and post-market surveillance information to maintain compliance.
At HaMaDa, we specialize in crafting high-quality Clinical Evaluation Reports (CERs) that meet the stringent requirements of MDR. With extensive experience in preparing over 100 CERs, our team offers unmatched expertise, working with all Notified Bodies and across diverse product technologies.
Our approach ensures clear, compliant, and thorough documentation that supports your regulatory submissions efficiently and effectively.
💡 Looking for expert guidance on CER under MDR?
Contact us today to learn more or request a quote.
