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

A10. Proposed checklist for the release of the clinical evaluation report

The following aspects should be checked for the release of a clinical evaluation report:

  • Can the report be read and understood by a third party, does it provide sufficient detail for understanding the data that are available, all assumptions made and all conclusions reached?
  • If clinical data have been generated and are held by the manufacturer, are all data mentioned and adequately summarised in the report?
  • If equivalence is claimed,
    • is demonstration of equivalence included in the report?
    • does the report disclose all the differences between the device under evaluation and the equivalent device?
    • does it explain why the differences are not expected to affect the clinical performance and clinical safety of the device?
  • If the product is already in the market in Europe or elsewhere, has the latest PMS/ PMCF data been taken into consideration and has it been summarised and referenced in the report?
  • In respect to current knowledge/ the state of the art,
    • has the report been updated?
    • is current knowledge/ the state of the art summarised in the report and is it adequately substantiated by literature?
    • does the content of the report fully correspond to current knowledge/ the state of the art?
    • does the report explain why the benefit/risk profile and the undesirable side-effects are acceptable in relation to current knowledge/ the state of the art?
  • If the report covers several models/ sizes/ settings and/or different clinical situations, is there sufficient clinical evidence and are the report’s conclusions correct for
    • all the devices?
    • all its sizes, models and settings?
      (including the smallest/ largest size, highest/ lowest dose, etc.)
    • every medical indication?
      (as described in the IFU/ not excluded with contraindications in the IFU)
    • the entire target population?
      (from pre term infants to old age, for males and females, etc., if not restricted in the IFU)
    • every form, stage and severity of the medical condition, as applicable?
      (including the most severe/ most benign forms, acute/ chronic stage, if not excluded in the IFU)
    • all intended users?
      (including lay persons, if not excluded in the IFU, and any unusual user group)
    • the whole duration of product use, including the maximal number of repeated exposure? (as allowed by the IFU)
    • if there are any discrepancies as to the above, are they identified in the report’s conclusions?
  • Is conformity to each of the relevant Essential Requirements (AIMDD ER1,2,5 / MDD ER1,3,6 ) clearly stated and are all discrepancies identified in the report’s conclusions?
  • Do the information materials supplied by the manufacturer correspond with the contents of the report and are all discrepancies identified in the report’s conclusions?
  • Do the report’s conclusions identify all residual risks and uncertainties or unanswered questions that should be addressed with PMS/ PMCF studies?
  • Is the report dated?
  • Is the qualification of the evaluators included in the report and correct?
  • Does the manufacturer hold a CV and declaration of interests of each of the evaluators and are these up-to-date?

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