ISO 10993-1:2018. Is it Harmonized?
FDA Consultants – CE marking Consultants
Reghelps
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The CER should contain all the documents required to prove the safety and performance of the device being evaluated. The three main sections are:
1. Scope of clinical evaluation : This section should include details of the device under evaluation, the technology used, directions for use, precautions etc.
2. Clinical background, current technology and state of the art: This section covers details of relevant medical conditions, available treatments, hazards etc.
3. Device under evaluation: This section outlines clinical data of the device obtained both from the manufacturer and from literature, appraisal and analysis of these data.
Another point to remember is that all necessary documents should be referenced and included.
For eg., if equivalence is claimed, the document to demonstrate equivalence should be prepared and attached along with the CER. Also the IFU, label etc. of the equivalent device should be provided for reference.
In addition to the above-said points, I would like to point out the detailed contents of a Clinical Evaluation Report in the link below:
https://www.i3cglobal.com/medical-device/ce-marking/clinical-evaluation/clinical-evaluation-report-CER.html