Are you ready to navigate the complexities of European market approval for your medical device? Download our comprehensive insight brief on Clinical Evaluation Reports (CERs) to understanding and mastering the requirements for CE marking.

What is a Clinical Evaluation Report?

The European Commission defines clinical evaluation as “a methodologically sound ongoing procedure to collect, appraise, and analyze clinical data pertaining to a medical device and to evaluate whether there is sufficient clinical evidence to confirm compliance with relevant essential requirements for safety and performance when using the device according to the manufacturer’s Instructions for Use.” This procedure is documented in the Clinical Evaluation Report (CER), which is mandatory for all risk classes.

Why is a CER Crucial?

A Clinical Evaluation Report (CER) is vital for obtaining European market approval for medical devices. It describes clinical data to demonstrate the safety and performance of the device under evaluation and assesses its benefit-risk ratio for the intended patient population. With the adoption of Medical Device Regulation 2017/745 (MDR), CERs are now subject to more rigorous scrutiny, both during the initial approval process and in the post-market phase.

What to Expect in Our Insight Brief

Our brief outlines the expectations of notified bodies (NBs) when reviewing CERs as part of the CE marking process. It provides practical suggestions for developing compliant, complete, and accurate documentation, including nine tips for creating compliant CERs:

1. Define Clinical Evaluation Plan (CEP) Strategy
2. Conduct a Systematic Literature Search
3. Present Stratified Clinical Data
4. Outline Specific Objectives
5. Provide Sufficient Data for Conformity Assessment
6. Thoroughly Evaluate Risks
7. Substantiate Clinical Claims
8. Recruit Experienced CER Authors and Evaluators
9. Update CERs Regularly

How IQVIA MedTech Can Help

A CER is one of the most critical documents required to obtain a CE Mark. Review the requirements carefully—an incomplete CER will be rejected by notified bodies. Given the increased scrutiny, partnering with an experienced regulatory partner like IQVIA MedTech can help make sure your CER and entire technical file are complete, accurate, and compliant with the latest regulations.

Download the full insight brief now to ensure your medical device meets all regulatory requirements and achieves successful market approval.