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

12. The role of the notified body in the assessment of clinical evaluation reports

The notified body plays a key role in the assessment and verification of clinical evaluation reports and supporting documentation provided by medical device manufacturers to support demonstration of conformity of a device with the Essential Requirements of the relevant Directive.

Detailed recommendations for notified bodies are given in Appendix A12 (Activities of notified bodies). These include:

  • guidance for notified bodies on the assessment of clinical evaluation reports provided by medical device manufacturers as part of technical documentation (including design dossiers) and
  • guidance for notified body in development of their internal procedures for assessment of clinical aspects relating to medical devices.

In addition, documents of the Notified Bodies Operations Group (NBOG) should also be consulted. NBOG documents include best practice guides, checklists and forms.

Pursuant to section 6a of Annex I MDD and to section 5a of Annex 1 AIMDD, the demonstration of conformity with the Essential Requirements must include a clinical evaluation conducted in accordance with Annex X of Directive 93/42/EEC or with Annex 7 AIMDD. This is applicable for all classes of medical device.

Where demonstration of conformity with Essential Requirements based on clinical data is not deemed appropriate this must be adequately justified by the manufacturer and based on the output of the risk management process. The device-body interaction, the intended purpose and the claims of the manufacturer have to be specifically considered. The adequacy of demonstration of conformity based on performance evaluation, bench testing and pre-clinical evaluation in the absence of clinical data must be duly substantiated. The notified body must review the manufacturer’s justification, the adequacy of data presented and whether or not conformity is demonstrated. Nevertheless a clinical evaluation is still required and the above information and an evidenced justification should be presented as the clinical evaluation for the device in question.

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