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

11. The clinical evaluation report (CER, Stage 4)

A clinical evaluation report shall be compiled to document the clinical evaluation and its output. The clinical evaluation report should contain sufficient information to be read and understood by an independent party (e.g. regulatory authority or notified body). Therefore, it should provide sufficient detail for understanding the search criteria adopted by the evaluators, data that are available, all assumptions made and all conclusions reached. The contents of the clinical evaluation report shall be cross-referenced to the relevant documents that support them. It should be clear which statements are substantiated by which data, and which reflect the conclusions or opinions of the evaluators. The report should include references to literature-based data and the titles and investigational codes (if relevant and available) of any clinical investigation reports, with cross-references to the location in the manufacturer’s technical documentation. The amount of information may differ according to the history of the device or technology. Where a new device or technology has been developed, the report would need to include an overview of the developmental process and the points in the development cycle at which all clinical data have been generated.

It is important that the report outlines the different stages of the clinical evaluation:

  • Stage 0, scope of the clinical evaluation:
    • explains the scope and context of the evaluation, including which products/ models/ sizes/ settings are covered by the clinical evaluation report, the technology on which the medical device is based, the conditions of use and the intended purpose of the device;
    • documents any claims made about the device’s clinical performance or clinical safety.
  • Stage 1, identification of pertinent data:
    • explains the literature search strategy;
    • presents the nature and extent of the clinical data and relevant pre-clinical data that have been identified.
  • Stage 2, appraisal of pertinent data:
    • explains the criteria used by the evaluators for appraising data sets;
    • summarises the pertinent data sets (methods, results, conclusions of the authors);
    • evaluates their methodological quality, scientific validity, the relevance for the evaluation, the weighting attributed to the evidence, and any limitations;
    • presents justifications for rejecting certain data or documents.
  • Stage 3, analysis of the clinical data:
    • explains if and how the referenced information, such as confirmation of compliance with clinical data requirement from applicable harmonised standards and the clinical data, constitute sufficient clinical evidence for demonstration of the clinical performance and clinical safety of the device under evaluation;
    • explains whether there are adequate data for all aspects of the intended purpose and for all products/ models/ sizes/ settings covered by the clinical evaluation.
    • describes the benefits and risks of the device (their nature, probability, extent, duration and frequency);
    • explains the acceptability of the benefit/risk profile according to current knowledge/ the state of the art in the medical fields concerned, with reference to applicable standards and guidance documents, available medical alternatives, and the analysis and conclusions of the evaluators on fulfilment of all Essential Requirements pertaining to clinical properties of the device (MDD ER1, ER3, ER6; AIMDD ER1, ER2, ER5);
    • analyses if there is consistency between the clinical data, the information materials supplied by the manufacturer, the risk management documentation for the device under evaluation;
    • whether there is consistency between these documents and the current knowledge/ the state of the art;
    • identifies any gaps and discrepancies;
    • identifies residual risks and uncertainties or unanswered questions (such as rare complications, uncertainties regarding medium- and long term performance, safety under wide-spread use) that should be further evaluated during PMS, including in PMCF studies.

The evaluators should check the clinical evaluation report, provide verification that it includes an accurate statement of their analysis and opinions, and sign the report. They should provide their CV and their declaration of interests to the manufacturer. The clinical evaluation report should be dated and version controlled. A suggested format for the clinical evaluation report is located at Appendix A9 (Clinical evaluation report – proposed table of contents, examples of contents). Suggestions for aspects that should be checked for the release of a clinical evaluation report are summarised in Appendix A10 (Proposed checklist for the release of the clinical evaluation report).

Information on declaration of interests can be found in Appendix A11 (Information on declarations of interests).

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