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

3. References

European Legislation:

  • Council Directive 90/385/EEC of 20 June 1990 relating to active implantable medical devices
  • Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
  • Commission Regulation 722/2012 of 8 August 2012 concerning active implantable medical devices and medical devices manufactured utilising tissues of animal origin
  • Commission Implementing Regulation 920/2013 of 24 September 2013 on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices

Harmonised and International standards:

  • EN ISO 14155:2011 Clinical investigation of medical devices for human subjects – Good clinical practice
  • EN ISO 14971:2012 Medical devices – application of risk management to medical devices

European guidance documents:

  • MEDDEV 2.12/1 Guidelines on a medical devices vigilance system
  • MEDDEV 2.12/2 Guidelines on post market clinical follow-up studies: a guide for manufacturer and notified body
  • MEDDEV 2.4/1 Classification of medical devices
  • MEDDEV 2.7/2 Guidelines for competent authorities for making a validation/assessment of a clinical investigation application under directives 90/385/EEC and 93/42/EC
  • Manual on borderline and classification in the Community regulatory framework for medical devices
  • NBOG BPG 2006-1 Change of notified body
  • NBOG BPG 2009-1 Guidance on design-dossier examination and report content
  • NBOG BPG 2009-4 Guidance on notified body‘s tasks of technical documentation assessment on a representative basis
  • NBOG BPG 2010-2 Guidance on audit report content
  • NBOG BPG 2014-1 Renewal of EC design-examination and type-examination certificates: Conformity assessment procedures and general rules
  • NBOG BPG 2014-2 Guidance on the information required for notified body medical device personnel involved in conformity assessment activities
  • NBOG BPG 2014-3 Guidance for manufacturers and notified bodies on reporting of design changes and changes of the quality system

Other guidance documents:

  • GHTF SG5 N1R7:2007: Clinical evidence – Key definitions and concepts
  • GHTF SG5 N2R8:2007: Clinical evaluation
  • GHTF SG5 N41R9:2005: Essential principles of safety and performance

This list contains documents available at the time this MEDDEV document was published. In
general, the most recent versions of standards and legal texts should be used.

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