Inhaltsübersicht

Inhaltsübersicht

1. Introduction
2. Scope
3. References
4. Definitions
5. Abbreviations
6. General principles of clinical evaluation
6.1 What is clinical evaluation?
6.2. When is clinical evaluation undertaken and why is it important?
6.3 How is a clinical evaluation performed?
6.4 Who should perform the clinical evaluation?
7. Definition of the scope of the clinical evaluation (Stage 0)
8. Identification of pertinent data (Stage 1)
8.1 Data generated and held by the manufacturer
8.2 Data retrieved from literature
9. Appraisal of pertinent data (Stage 2)
9.1 General considerations
9.2 The appraisal plan
9.3 Conduct of the appraisal
10. Analysis of the clinical data (Stage 3)
10.1 General considerations
10.2 Specific considerations
10.3 Where demonstration of conformity based on clinical data is not deemed appropriate
11. The clinical evaluation report (CER, Stage 4)
12. The role of the notified body in the assessment of clinical evaluation reports

Anhänge

A1 Demonstration of equivalence
A2 When should additional clinical investigations be carried out?
A3 Device description – typical contents
A4 Sources of literature
A5 Literature search and literature review protocol, key elements
A5.1 Background to the literature search and the literature review
A5.2 Objective
A5.3 Methods
A6 Appraisal of clinical data – examples of studies that lack scientific validity for demonstration of adequate clinical performance and/or clinical safety
A7 Analysis of the clinical data – compliance to specific Essential Requirements
A7.1 Conformity assessment with requirement on safety (MDD ER1 / AIMDD ER1)
A7.2 Conformity Conformity assessment with requirement on acceptable benefit/risk profile (MDD ER1 / AIMDD ER1)
A7.3 Conformity assessment with requirement on performance (MDD ER3 / AIMDD ER2)
A7.4 Conformity assessment with requirement on acceptability of undesirable side-effects (MDD ER6 / AIMDD ER5)
A8 Devices for unmet medical needs – aspects to consider
A9 Clinical evaluation report – proposed table of contents, examples of contents
A10 Proposed checklist for the release of the clinical evaluation report
A11 Information on declarations of interests
A12 Activities of notified bodies
A12.1 Notified body assessment of clinical evaluation by conformity assessment route
A12.2 Examination of a design dossier (Annex II.4; Annex 2.4) or of a type examination dossier (Annex III; Annex 3)
A12.3 Evaluation as part of quality system related procedures
A12.4 Notified body specific procedures and expertise

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.

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