<\/span><\/h2>\n\n\n\nIt is the manufacturer’s\nresponsibility provide the agencies or other notified bodies with a clinical\ndata summary on device performance. The architecture of a CER report is the\nsame, even though the details vary depending on the type of\ndevice\u202fmanufactured. <\/p>\n\n\n\n
1. Summary<\/strong> <\/p>\n\n\n\nThe summary is an overview of the\nCER report for external audiences at agencies\/notified bodies. This section\nshould summarize the: <\/p>\n\n\n\n
- Benefit\/Risk Profile <\/li>
- Intended Target Groups <\/li>
- Medical Indications <\/li><\/ul>\n\n\n\n
The summary should briefly explain\nhow your manufacturing company came to the conclusion that the device has an\nacceptable benefit or the risk profile based on the “state of the\nart” medical evidence & research in addition to summarizing those\nfindings. <\/p>\n\n\n\n
2. Scope<\/strong> <\/p>\n\n\n\nThis part ought to be very explicit\non how the device operates and the technology involved. For extremely\ninnovative devices or other devices that utilize advanced technologies, the\nscope section of a report may be quite lengthy. <\/p>\n\n\n\n
3. Clinical Background<\/strong> <\/p>\n\n\n\nAn extensive review of the clinical\ncontext\u202faround the medical device is intended for the clinical background part\nof a CER report. To provide reviewers with an idea of the current status of the\nfield for the medical device under evaluation, authors should provide an\noutline of a literature review. <\/p>\n\n\n\n
4. Device under Evaluation<\/strong> <\/p>\n\n\n\nThe purpose of the section on the\ndevice under evaluation is to not only describe the device but also to explain\nthe procedures used for the CER and the data analysis. A clinical evaluation’s\nbasis, an equivalency demonstration (if appropriate), and the clinical data\nsets used should all be included. If the clinical evaluation is not supported\nby scientific literature, this part must explain why and provide equivalence\nexplanation. <\/p>\n\n\n\n
5. Conclusions<\/strong> <\/p>\n\n\n\nThe explicit justification that the\ndevice complies with important necessities for patient safety forms the\nfoundation of the CER decision. It should discuss the benefit\/risk profile\ncreated during the analysis of clinical data and draw on the most recent\nresearch to demonstrate whether the device and any associated risks are\nsuperior to medical alternatives. <\/p>\n\n\n\n
6. Dates & References:<\/strong> <\/p>\n\n\n\nThe final section of the report\noperates similar to an appendix in an academic paper. It should include the\nfollowing: <\/p>\n\n\n\n
- Next clinical evaluation<\/li>
- Date. <\/li>
- Current clinical evaluation date. <\/li>
- A signed statement from the evaluator. <\/li>
- Final release data from the manufacturer. <\/li>
- Evaluator Qualifications. <\/li>
- References <\/li><\/ul>\n\n\n\n