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

A3. Device description – typical contents

 

The description should be detailed enough to allow for a valid evaluation of the state of compliance with Essential Requirements, the retrieval of meaningful literature data and, if applicable, the assessment of equivalence to other devices described in the scientific literature:

  • name, models, sizes, components of the device, including software and accessories
  • device group to which the device belongs (e.g. biological artificial aortic valve)
  • whether the device is being developed/ undergoing initial CE-marking/ is CE-marked
  • whether the device is currently on the market in Europe or in other countries, since when, number of devices placed on the market
  • intended purpose of the device
    • exact medical indications (if applicable)
    • name of disease or condition/ clinical form, stage, severity/ symptoms or aspects to be treated, managed or diagnosed
    • patient populations (adults / children / infants, other aspects)
    • intended user (use by health care professional / lay person)
    • organs / parts of the body / tissues or body fluids contacted by the device
    • duration of use or contact with the body
    • repeat applications, including any restrictions as to the number or duration of re- applications
    • contact with mucosal membranes/ invasiveness/ implantation
    • contraindications
    • precautions required by the manufacturer
    • single use / reusable
    • other aspects
  • general description of the medical device including
    • a concise physical and chemical description
    • the technical specifications, mechanical characteristics
    • sterility
    • radioactivity
    • how the device achieves its intended purpose
    • principles of operation
    • materials used in the device with focus on materials coming in contact (directly or indirectly) with the patient/ user, description of body parts concerned
    • whether it incorporates a medicinal substance (already on the market or new), animal tissues, or blood components, the purpose of the component
    • other aspects
  • whether the device is intended to cover medical needs that are otherwise unmet/ if there are medical alternatives to the device / if the device is equivalent to an existing device, with a description of the situation and any new features
  • if the device is intended to enter the market based on equivalence:
    • name, models, sizes, settings components of the device presumed to be equivalent, including software and accessories
    • whether equivalence has already been demonstrated
  • Intended performance, including the technical performance of the device intended by the manufacturer, the intended clinical benefits, claims regarding clinical performance and clinical safety that the manufacturer intends to use
  • For devices based on predecessor devices: Name, models, sizes of the predecessor device, whether the predecessor device is still on the market, description of the modifications, date of the modifications.
  • The current version number or date of the information materials supplied by the manufacturer (label, IFU, available promotional materials and accompanying documents possibly foreseen by the manufacturer).

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