Clinical Evaluation Report
This is the final stage of the clinical evaluation process, where you document the results of all your clinical development activities, and all post-market and safety data to come in the future.
Throughout your Clinical Evaluation process, you will have created a wealth of information and documentation that will feed into your final Clinical Evaluation Report.
Alongside other essential documentation, your Clinical Evaluation Report (CER) is how you demonstrate to regulators your conformity with the regulations and will also become part of your technical documentation. Furthermore, the information in your CER and the clinical data on which it is based make up the clinical evidence that you will go on to use in the marketing of your device so it’s important to be thorough and objective throughout the process.
At the end of the process, your final Clinical Evaluation Report will be the core document that regulators will review to evaluate the safety and performance of your SaMD/AIaMD. The clinical evaluation process is also required to be updated throughout the device’s lifecycle and this involves actively updating the CER with post-market surveillance data.
Best Practices
Align with internationally recognised standards
The CER is a requirement for every medical device (even software and AI-based tools) intending to be sold in the European Union. Article 61 of the EU MDR states the need for the documentation of the entire clinical evaluation process to be included in the Clinical Evaluation Report (CER). The MEDDEV 2.7.1 Rev 4 and MDCG 2020-1 guidance goes into further detail to help you with creating your CER by breaking down each stage individually and outlining what should be included in the report. The IMDRF’s Clinical Evaluation guidance also provides a suggested format for the CER in Appendix G.
Case Study
How Hardian solves the problem.
Hardian has worked with several clients to draft and submit Clinical Evaluation Reports as part of regulatory submissions. We’ve worked closely with clients such as Lunit Inc. and Methinks AI to build a Clinical Evaluation Report that passed review by EU notified bodies. As the culmination of the entire clinical evaluation process, the CER is the core document, and Hardian’s deep knowledge and collaborative process will help you in producing a clear, effective and comprehensive CER.
Get in touch
Get in touch to see how Hardian can help you with every step of the clinical evaluation process including your Clinical Evaluation Report.