Once you have a compliant CER for your marketed device, updating it with data from surveillance or ongoing clinical programs is essential. We use different process that may help enrich your CER and optimize acceptance from Authorities.
The CEP, search histories, and included data need to be appended to the CER. The CER and appendices form both the clinical evidence and part of the technical documentation for the device.
There needs to be sufficient information provided to enable the assessor to understand the device and its application, but it should be concise and limited to relevant data. The clinical data and evaluation should form the bulk of the main body of the CER.
Content must be adequately and accurately referenced. This includes applied regulations and standards, clinical background to device or general statements, Technical File/PMS/risk management documentation and previous CER versions.
The CER should be signed and dated by the author and by appropriately authorised reviewers. The author’s CV and/or justification with regard to their appropriate qualification should be included. Furthermore, declarations of interest for the authors and reviewers should be provided.
The CER must have a strong conclusion, summarising the findings of the evaluation and clearly stating the conclusions with regard to each of the elements. Ensure the MEDDEV 2.7/1 elements (see below) are incorporated and also identify any additional actions to be taken with regard to risk management or the generation of additional data.
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Twelve (12) months ago, the EU Commission published a Notice to Stakeholders, “Withdrawal of the United Kingdom and EU Rules in the Field of Industrial Products,”Read More..
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