This form sets the minimum content we must collect to document evaluator impartiality for a Clinical Evaluation Report and to disclose any relationships that could affect objectivity.

• Identify the Clinical Evaluation Report scope: Manufacturer Name, Device Name, and Doc+rev

• Confirm personal involvement and describe the evaluator’s role in the evaluation activities

• Declare employment status (employee or independent consultant for the manufacturer)

• Disclose financial compensation, funding, or material benefits beyond contractual terms

• Confirm compensation is not linked to outcomes of the clinical evaluation

• Declare intellectual property rights (patents/copyrights/trademarks) related to the device

• Capture any other potential conflicts of interest (e.g., competitors, advisory roles)

• Complete signature, name, date, and title for accountability

This Declaration of Interest form is used alongside the clinical evaluation report to document the evaluator’s objectivity and ensure transparent disclosure of interests.

Key requirements covered include defining personal involvement (what the evaluator did and why it matters for accountability) and conflicts of interest (relationships that could bias judgment and must be disclosed).

• Link the declaration to the specific report using Device Name and Doc+rev

• State evaluator role and scope of involvement

• Record employment status with the manufacturer

• Disclose financial compensation and confirm it is not outcome-based

• Declare related intellectual property rights

• Document any additional potential conflicts of interest

• Provide signature, date, and identity details

At Lexqara, we help align clinical documentation packs with robust governance, including independent review workflows, QMS integration, and audit-ready records. Visit our Resource Center [https://lexqara.com/resource-center] and explore Clinical Documentation support [https://lexqara.com/services/clinical-documentation], and consult the European Commission medical devices overview [https://health.ec.europa.eu/medical-devices-sector_en]. Download the template and request a short gap assessment.