Declaration of Interest

Clinical evaluation template

Declaration of Interest for medical device clinical evaluation

Use this editable Declaration of Interest to structure clinical evidence, justify safety and performance conclusions, and keep your MDR/IVDR clinical evaluation documentation audit-ready.

Structure clinical evidenceCollect, appraise and analyse data with a repeatable methodology.

Align with MDCG 2020-6Rank and weight clinical data according to EU guidance.

Support notified-body reviewTrace decisions from evidence to GSPR conclusions.

Best for: clinical evaluation planning, CER/CEP/SSCP preparation, PMCF evidence review and literature appraisal.
Includes: editable sections aligned with MDR Annex XIV, MDCG 2020-6 and relevant MEDDEV guidance.
Format: editable template available through the standard WooCommerce download flow.

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At Lexqara, we connect clinical documentation, PMS activities and regulatory strategy so manufacturers can build defensible clinical evidence packages. Explore the Resource Center, review our Clinical Evaluation Services, or consult MDCG 2020-6 for the clinical evidence hierarchy.

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.

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Template preview: Declaration of Interest

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For the [Manufacturer Name]’s Clinical Evaluation Report on [Device Name]: [Doc+rev]

Introduction

This Declaration of Interest is submitted as part of the clinical evaluation report for the product [Device Name]. The declaration ensures transparency regarding any relationships or interests that could potentially influence the objectivity of this report.

Personal Involvement

The undersigned declares the following:

I, XXX evaluator name, have been involved in the clinical evaluation of [Device Name], which is the subject of this report.

My role in this evaluation includes XXX insert roles, e.g., conducting clinical studies, reviewing literature, preparing the report, etc.

Employment and Financial Interests

I am XXX state your employment status, e.g., “an employee of” or “independent consultant for [Manufacturer Name].

I declare that I have not /or have received any financial compensation, funding, or other material benefits in relation to this evaluation, beyond what has been contractually agreed upon with [Manufacturer Name].

I confirm that my compensation is not linked to the outcomes of the clinical evaluation report.

Intellectual Property Interests

I declare that I do not/do hold any intellectual property rights (patents, copyrights, or trademarks) directly related to [Device Name].

If applicable: I hold XXX insert patent/copyright information which may be associated with the technology used in [Device Name].

Other Potential Conflicts of Interest

The undersigned declares the following additional potential conflicts of interest:

XXX Insert any other relevant information regarding potential conflicts, such as consulting agreements with competitors, previous employment, advisory roles, etc.

Conclusion

I declare that, to the best of my knowledge, all potential conflicts of interest have been disclosed, and none of these interests has compromised the integrity or objectivity of the clinical evaluation report. My conclusions and assessments in this report are based solely on scientific evidence and clinical data reviewed.

Signature


Name:	Date:
Title:	Signature:

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SKU FORM-RR-014 rev.1 Category Clinical Documents

Declaration of Interest