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A4. Sources of literature

There are different sources of clinical literature that can be searched for clinical evaluation. A comprehensive search strategy is required, normally involving multiple databases. The search strategy should be documented and justified. Important sources include the following:

• Scientific literature databases
  • MEDLINE or Pubmed can provide a good starting point for a search. However, with possibly incomplete coverage of European Journals and reduced search features, comprehensiveness may not necessarily be guaranteed.
  • Additional databases may need to be used to ensure adequate coverage of devices and therapies in use in Europe, to identify relevant clinical trials and publications of user experience16, and to facilitate searches by device name and manufacturer (e.g. EMBASE/Excerpta Medica, the Cochrane CENTRAL trials register, etc.).
  • Information coverage and search features available in scientific databases can change with time. Criteria for selecting adequate databases therefore need to be defined and re- evaluated on a regular basis.
• Internet searches
  Searches provide important data, examples include information on:

• harmonised standards and other standards applicable to the device in question and containing information on clinical performance and clinical safety.
• Field safety corrective actions for the equivalent and/or other devices. These can be found on manufacturer’s web sites, internet sites of European Competent authorities, the U.S. Food and Drug Administration (FDA), possibly other sites.
• Implant registry reports.
• Documents available in systematic review databases (e.g. the Cochrane Database of Systematic Reviews, Prospero international prospective register of systematic reviews).
• Expert documents produced by professional medical associations that are important for assessment of current knowledge/ the state of the art, including clinical practice guidelines and consensus statements.
• Meta-analyses and reviews of health technology assessment (HTA) institutes and networks.
• Identification of studies via the WHO International Clinical Trials Registry Platform (ICTRP) and ClinicalTrials.gov.
• Non-published data
  Non published data are important for many devices and retrieval of such data should be considered, including for monitoring of any changes, e.g.
• The label and IFU of the equivalent device (if equivalence is claimed by the manufacturer) and/or of benchmark devices and other devices.
• Data provided to manufacturers from implant registries.
• Data presented at congresses.
• Citations referenced in scientific literature can be important and should be screened.
  Literature found to be relevant is likely to cite other literature that is of direct interest to the manufacturer. Additionally, it may be necessary to retrieve some of the referenced literature in order to appraise the scientific quality of a document.