11–14. Conclusions, Author CVs, References, Excluded sources

Source: CER Template.pdf page 25 (document: Mantra Systems Free CER Template, Edition 2)

11. Conclusions

In this section, provide closing remarks that draw the CER to a close.

Refer to the hypothesis outlined at the start of the CER and state whether the consideration of clinical evidence in the evaluation has proven the hypothesis to be true.

Describe if there is consistency between all documents and the current knowledge/state of the art. Are there any unacceptable residual risks?

Overall, is ongoing approval of the subject device supported?

12. Author CVs

Include CVs of the authors of the CER.

13. References

Include a bibliography of all sources used in the CER.

14. Excluded sources

Include a record of each source excluded against each search term, along with a justification for exclusion of each.