A declaration of interest is a formal document designed to make potential conflicts of interest transparent. Individuals submit a declaration of interest to demonstrate their objectivity and independence.
This article is about declarations of interest in a clinical context.
1. What is the objective of a declaration of interest?
A declaration of interest aims to create trust in work results such as clinical evaluations and expert reports. This is achieved by
- transparency, e.g., regarding potential conflicts of interest,
- ensuring independence and impartiality, and
- compliance with ethical standards and regulatory requirements.

2. Who demands a declaration of interest from whom?
Various laws and standards require a declaration of interest.
a) Article 107 MDR (not relevant to manufacturers)
Article 107 MDR requires several groups to declare all direct and indirect interests in the medical device ecosystem:
- Members of the Medical Device Coordination Group (MDCG) and its subgroups
- Members of the expert panels and expert laboratories
- Experts and other third parties consulted by the MDCG on a case-by-case basis
The declaration is intended to serve impartiality and must include:
- Financial and other interests in the medical device industry that could influence the impartiality
- Obligation to act independently and in the public interest
- Disclosure of all direct and indirect interests
b) Regulation (EU) 2021/2282 (not relevant to manufacturers)
Regulation (EU) 2021/2288 on health technology assessment also requires disclosure of financial or other interests in the health technology development industry that could affect independence or impartiality, and this applies to:
- Representatives of the HTA Coordination Group and its sub-groups
- Patients, clinical experts, and other relevant experts participating in joint activities
The objective of this requirement is to ensure the independence and impartiality of these groups.
c) German MPDG § 32 (not relevant to manufacturers)
§ 32 (only available in German) of the MPDG requires a provision in the rules of procedure or statutes of ethics commissions. These documents must include declarations of independence from the participating members and external experts. The MPDG also pursues disclosing financial or personal interests that could influence impartiality.
d) MEDDEV 2.7/1 rev. 4 and the MDCG follow-up document
The most relevant document for manufacturers is MEDDEV 2.7/1 rev. 4 or the draft MDCG document “Clinical evaluation under regulation (EU) 2017/745,” which adopts the requirements of MEDDEV word for word.
These documents require both manufacturers and their evaluators to make a declaration of interest in the case of clinical evaluations.
Each evaluator and the manufacturer must sign this declaration of interest, which must be part of the clinical evaluation.
The MEDDEV and MDCG specifications define the contents of this “DOI” precisely:
- Employment by the manufacturer
- Participation as an investigator in the clinical study of the device, or in pre-clinical testings of the device
- Ownership/shareholding possibly affected by the outcome of the evaluation
- Grants sponsored by the manufacturer
- Benefits such as travel or hospitality (if beyond what is reasonably necessary for 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 results of the evaluation
In addition, the scope of the declaration should be clarified:
- Time span included (e.g., grants, sources of revenues or benefits paid or promised to be paid over the 36 months prior the evaluation)
- Financial interests of family members
e) ISO 14155
ISO 14155 (“Clinical investigation of medical devices for human use – Good clinical practice”) is also relevant for manufacturers planning or conducting clinical investigations.
Accordingly, principal investigators must disclose potential conflicts of interest (including financial ones) that may influence the conduct of the clinical investigation or the interpretation of the results.
In the case of the safety assessment of adverse events, the standard notes that these can be classified by an independent Clinical Events Committee (CEC) to avoid bias and financial conflicts of interest.
In this way, the standard also pursues the objective of independence for the persons involved.
The information required by the standard is less extensive than for MEDDEV/MDCG:
- Type of employment
- Financial benefits
- Existing property rights
- Date and signature
3. How do you structure a declaration of interest?
There are no legal requirements for how a declaration of interest should be structured or formulated. However, tabular presentations have proven useful, and the EU plans to use them for the HTA Coordination Group.
A possible presentation that considers the contents of MEDDEV 2.7/1 rev. 4 is as follows:
Source of the conflict of interest | Evaluation | Details (if yes) |
1. Type of employment with manufacturer | ||
Have you had any current or previous employment, consultancy, or other professional relationships with any device manufacturer in the past 36 months? | ☐ Yes ☐ No | |
2. Participation as an investigator in the clinical study or in preclinical tests | ||
Have you been involved in the device in question as an investigator or researcher in clinical investigations or pre-clinical tests in the last 36 months? | ☐ Yes ☐ No | |
3. Interests in connection with the manufacture of the device | ||
Have you had any interests directly related to the manufacture or development of the device in the past 36 months? | ☐ Yes ☐ No | |
4. Ownership/shareholdings | ||
Do you currently own, or have you owned in the past 36 months, shares, stocks, or other ownership interests that could benefit or be affected by the outcome of the clinical evaluation? | ☐ Yes ☐ No | |
5. Interests in connection with intellectual property | ||
Do you currently own or have you owned in the last 36 months any patents, copyrights, or royalties that could be affected by the outcome of the clinical evaluation? | ☐ Yes ☐ No | |
6. Financial benefits/grants | ||
Have you received any financial benefits or grants from the device manufacturer in the past 36 months? This also includes benefits such as travel and hospitality that go beyond usual and necessary professional requirements. | ☐ Yes ☐ No | |
7. Other interests or sources of income | ||
Have you had other financial interests or sources of income in the past 36 months that could potentially be affected by the outcome of the clinical evaluation? | ☐ Yes ☐ No |
4. How can the Johner Institute help?
The table above should eliminate the need for help with structuring and wording. However, there are sometimes uncertainties as to when a situation arises that requires a “yes” answer to one of the above questions.
The most important support that the Johner Institute provides for manufacturers of medical devices and IVD is to ensure that clinical evaluations are legally and standards compliant (by writing, revising, or reviewing them) without unnecessary effort, thus ensuring smooth audits, file reviews, and approvals.
5. Conclusion and summary
Organizations that disclose potential conflicts of interest and create objective assessments have no difficulty making legally compliant declarations of interest. With the help of templates, this task is quick and easy to complete.