Evaluation (Validation and Verification) - Medical Device Design: Innovation from Concept to Market - page 251

9.8 Format for Formal Clinical Evaluation Report
The format of the overall report is left to the company. However to make it useful for both
FDA and CE uses it should be written in such a way that the data can be extracted easily for
any purpose. To this end a format is not suggested but it is suggested you follow the guidance
in MEDDEV 2.7.1 rev 3 or that laid down in the Format for Traditional and Abbreviated
510(k)s ( FDA, 2005 ). Both contain similar information but it is impossible to complete
the 510(k) submission without conducting the evaluation described earlier; equally the
information used for the 510(k) submission is identical to that one would produce for the
MEDDEV report. Hence the following structure may be useful as a starting point.

Section Content

Title Page

1 Executive Summary

2 Indications for Use 5

3 Declarations of Conformity

4 Device Description

5 Classiication

6 Proposed Labeling and IFU

7 Literature Review

8 Substantial Equivalence

9 Sterilization and Shelf Life

10 Biocompatibility

11 Software

12 Electromagnetic Compatibility and Electrical Safety

13 Performance Testing - in vitro

14 Performance Testing - animal

15 Performance Testing - in vivo

16 Other

Note: sections 8-15 cover the whole of the evaluation process and will refer back to the
literature review and the classification. However some may not be applicable to your device;
do not simply discard them. Keep them in the report and justify why there is no content. So,
for example, there may be no clinical trial data because the literature review and substantial
equivalence have demonstrated that the device is in common use and as such a clinical study
is not required to demonstrate safety. Making this statement is just as powerful as having the
data itself.

Remember, if you are presenting data in sections 8-15 then the literature review should be
referred to in such a way that both support one another, giving your justifications credence.
For example, if your screw breaks at 6 Nm (section 13) then the data should be compared
with the literature review, which hopefully demonstrates that your device matches or exceeds
the norm.

5 Include any contraindications or guidance.