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

A8. Devices for unmet medical needs – aspects to consider

Like all medical devices, medical devices for unmet medical needs must fully comply with the Essential Requirements in order to be CE-marked. The evaluators should assess whether devices deliver clinical benefits to patients for

  • medical conditions that are life threatening, or cause permanent impairment of a body function, and
  • for which current medical alternatives are insufficient or carry significant risks.

Corresponding devices are referred to as “breakthrough products” in this Appendix.

  1. Breakthrough products
    In exceptional cases, major benefits may justify relatively high levels of uncertainty, and access to the market may be granted on the basis of limited clinical evidence such as
  • experience available from compassionate use/ humanitarian exemption programs, use of custom-made devices, results of feasibility studies;
  • limited long-term data.

In addition to general aspects described in this MEDDEV document, the evaluators should fully disclose the situation and address the following items in the clinical evaluation report:

  • the exact intended purpose, including the medical indication (if applicable to the device), the product was developed for and whether residual risks and uncertainties or unanswered questions are considered acceptable in this indication (often a niche indication);
  • explanations of why current medical alternatives are considered to be insufficient or to carry significant risks;
  • explanations of the benefits delivered by the device under evaluation;
  • whether the IFU clearly describe
    • the exact intended purpose (including medical indications) and any limitations,
    • the limited clinical experience,
    • uncertainties or unanswered questions about residual risks and benefits to patients19;
  • the need to set up a stringent PMCF plan with information on
    • the type and quality of data that needs to be generated in the post-market phase in order to further evaluate the clinical performance and clinical safety of the device;
    • how to generate data in a timely manner and aspects thereof, including projections on the numbers of patients that will be managed with the device per year;
    • in the following cases, the manufacturer should aim at including all patients in PMCF studies:
      • a device that carries significant risks (i.e. expected to cause serious adverse events), or
      • a device for rare diseases.
    • the need to actively update the clinical evaluation report when new significant information become available, and in accordance with Section 6.2.3 b of the present document.
  • In these exceptional cases, notified bodies should perform annual assessments of the updated clinical evaluation reports and the results of PMCF studies.
  • Subsequent products
    Devices that enter the market subsequent to a therapeutic/ diagnostic breakthrough can not be judged by the same criteria as listed above for breakthrough devices. When performing a clinical evaluation for these devices, the following considerations should be taken into account:
  • when a device enters the market subsequent to a therapeutic/diagnostic breakthrough, clinical evidence is likely to have evolved rapidly since the first breakthrough device became available
  • with the evolving body of evidence, entering the market with large uncertainty may no longer be legitimate
  • if PMCF data are required, PMCF Studies should also be foreseen for devices that enter the market subsequent to a therapeutic/ therapeutic breakthrough

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