The Clinical Evaluation Report (CER) is an integral part of conformity evaluation of a medical device and the manufacturer’s needs to take into account various important considerations in the CE report writing process. The manufacturers of the devices need to outline the scope and the clinical evaluation framework of their products in the CER, which includes the actual clinical data with the detailed description of the assessment and analysis stages and proper conclusions to verify the safety and performance of the devices.
The Clinical report writing needs to specify the benefits and risks associated with the product with regards to its physical attributes, probability, degree, duration and frequency of occurrence. It needs to incorporate the benefits/risk profile, probable undesirable side effects and risk mitigation measures undertaken by the manufacturer and the conformity of the health and safety standards. CE report writing needs to specify intended purpose of use, general instructions for the user groups and technical attributes of the medical device that are adequately supported by relevant clinical evidence
Important considerations for CE Report writing
- Proper understanding Recent MEDDEV guidelines
The medical device manufacturer needs to have sufficient understanding of the latest MEDDEV guidelines before starting the CER writing process. Appendix E of the guidelines suggests the appropriate format for creating CER and the Appendix F provides the checklist for the regulatory bodies to be used during the confirmatory assessment process. It is imperative for the manufacturers to evaluate their work against these checklists and guidelines to ensure all prerequisites are met.
2. Sufficient Time Allocatione
Depending upon the scope of the document, preparation of CER is a stressful and time-consuming process and it requires proper planning and adequate time at every stage of the process. It can have many unforeseen delays in many areas such as clinical data collection, analysis and in the report writing. Thus, the process must be planned and started well in advance of the assessment deadline.
3. Require Regular updates
The manufacturer needs to understand that the CE report is not a stand-alone document, but rather a live document, which requires continuous updates by including new clinical data findings relating to medical equipment. The updates need to specify whether the device is established after innovational considerations and whether the manufacturing process has undergone any design and procedural changes.
4. Clinical evaluation description
The clinical assessment is conducted through a comprehensive analysis of the clinical data that are available from the pre-and post –market investigation, which includes various data relating to clinical performance and clinical safety.
The CE report writing needs to elaborate various stages involved in the clinical evaluation process that includes;
- Scope definition and clinical evaluation plan
- Identification of pertinent data
- Individual data appraisal activities pertaining to its scientific validity and relevance
- Description of the materials used in the device including the label and other accompanying documents
- Conformity of essential compliance requirements in terms of the performance and safety of the medical device under assessment
- Benefits/risk profile, residual risks
- Data analysis and conclusion
Considering the complexity and the time-consuming nature of the CE report preparation, an increasing number of manufacturers prefer to take professional assistance from CE report writers who have high expertise and experience in the specialized field of CE Report creation process.
Contact us for more information about how we can help you to develop CER report.
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