Clinical Evaluation Systematic Literature Review - Apec-ahc.org

APPENDIX B:
A POSSIBLE METHODOLOGY FOR DOCUMENTING THE SCREENING AND SELECTION OF
LITERATURE WITHIN A LITERATURE SEARCH REPORT 6
Potentially relevant literature identified
through the search
(copy of all citations)
Literature retrieved for more detailed
assessment
Literature with relevant useable data
included in the clinical evaluation, by
outcome:
• Device performance*
• Device safety*
• Device comparability
(if applicable)
*some literature will address issue of both performance and safety
___________________________________
Literature excluded, with reasons
Literature excluded from clinical
evaluation, with reasons
6 Adapted from Moher D, Cook DJ, Eastwood S, Olkin I, Rennie, D & Stroup DF. Improving the quality of reports and meta-analyses of randomised controlled trials: the QUORUM
statement. Quality of Reporting of Meta-analyses. Lancet 1999; 354:1896-1900
page 27 of 46
MEDDEV. 2.7.1 Rev.3, page 27
Data generated Through Clinical Experience
• Manufacturer-generated post market surveillance
reports
• Registries or cohort studies
• Adverse events databases
• Compassionate usage programs
• Clinically relevant field corrective actions
MEDDEV. 2.7.1 Rev.3, page 12
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