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


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

A11. Information on declarations of interests

Declarations of interests of the evaluators should be held by the manufacturer and cover relevant financial interests outside the current work as an evaluator.

Declarations of interests should contain statements that clarify the extent of the declaration. For example:

  • the time span included (e.g. grants, sources of revenue or benefits paid or promised to be paid over the 36 months prior to the evaluation)
  • whether financial interests of family members are included or not (namely spouse or partner living in the same residence as the evaluator, children and adults for whom the evaluators is legally responsible)

Typical contents:

  • employment by the manufacturer
  • participation as an investigator in clinical studies of the device, or in pre-clinical testing of the device
  • ownership/ shareholding possibly affected by the outcome of the evaluation
  • grants sponsored by the manufacturer
  • benefits such as travelling or hospitality (if beyond what is reasonably necessary for the work as an employee or external evaluator)
  • interests in connection with the manufacturing of the device or its constituents
  • interests in connection with intellectual property, such as patents, copyrights and royalties (whether pending, issued or licensed) possibly affected by the outcome of the evaluation
  • other interests or sources of revenues possibly affected by the result of the evaluation

The declaration of interests should be dated and signed by the evaluator and the manufacturer.

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