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Clinical evidence guidelines: Medical devices
Appendix 1: CER and supporting documents
The following list outlines the recommended heading structure for the CER.
Indicate that each of the relevant recommended sections has been included, who authored each section, and on which page(s) they can be located within the CER.
|1. Device description, lineage and version (if applicable)||Yes No N/A|
|2.Intended purpose / indications, and claims||Yes No N/A|
|3. Regulatory status in other countries||Yes No N/A|
|4. Summary of relevant pre-clinical data||Yes No N/A|
|5. Demonstration of substantial equivalence (if applicable)||Yes No N/A|
|6. Overview and appraisal of clinical data||Yes No N/A|
|7. Critical evaluation of clinical data including post market data||Yes No N/A|
|8. Risk-benefit analysis||Yes No N/A|
|9. Conclusions||Yes No N/A|
|10. Name, signature and curriculum vitae of clinical expert and date of report||Yes No N/A|
The following information on the device must also be provided for pre market (conformity assessment reviews and applications for inclusion) and post-market reviews in addition to the CER.
Risk assessment and management document
|Yes No N/A|
IFU, product manual and all other documents supplied with the device.
|Yes No N/A|
Additional information should be provided as applicable. This may include (but is not limited to) those below.
|Additional information on the device||Yes No N/A|
|Preclinical data (if relevant)||Yes No N/A|
|Full clinical investigation reports||Yes No N/A|
|Literature search and selection strategy||Yes No N/A|
|Full text of pivotal articles from the literature review||Yes No N/A|