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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