Dutch IGJ Publishes Inspection Report on Transparency of Benefit Transfers in the Dental Medical Device Sector (22 June 2026)

Key Takeaways

• On 22 June 2026 the Dutch Health and Youth Care Inspectorate (IGJ) published an inspection report on the dental medical device sector.
• IGJ found that financial relationships between suppliers and medical professionals were not always sufficiently transparent, that service agreements were sometimes missing altogether, that some sponsorship agreements lacked traceability, and that in one case gifts were provided in breach of the rules.
• IGJ imposed administrative measures, including warnings and fines, on the suppliers and medical professionals concerned, and gave other legal entities feedback on areas requiring improvement.
• In 2026 IGJ will extend supervision of transfers of benefit to cardiology and oral and maxillofacial surgery departments in hospitals and private clinics in the Netherlands.
• Manufacturers and their Dutch partners should review service agreements, sponsorship, gifts and governance policies against Article 6 of the Dutch Medical Devices Act (Wmh), the policy rule on transfers of benefit and the GMH Code of Conduct, and align international internal policies with Dutch law.

Source and Applicability

Issuing authority: Health and Youth Care Inspectorate (IGJ), the Netherlands. Date of the original report: 22 June 2026. Source: IGJ public information, https://www.igj.nl/documenten/2026/06/22/sector-tandheelkundige-medische-hulpmiddelen-onvoldoende-bekend-met-wet-en-regelgeving-gunstbetoon.

This article is a translated and edited summary of publicly available IGJ information. The binding requirements remain those formally issued by the competent authorities in their most recent publications.

Full Translation of the IGJ Inspection Report (22 June 2026)

Report date: 22 June 2026

The Dutch dental medical device sector is insufficiently aware of the importance of transparent financial relationships. Inspections by the Dutch Health and Youth Care Inspectorate (IGJ) show that payments are not always sufficiently transparent and that dental medical device suppliers and medical professionals sometimes have no written agreement in place. In one case gifts were provided. Suppliers and medical professionals therefore did not comply with the legislation and regulations on transfers of benefit. IGJ has imposed a fine for this.

Suppliers and medical professionals maintain financial relationships with one another. Such relationships require care and transparency. Financial relationships can help improve the quality of care, but they can also create influence that prevents patients from receiving the most suitable medical device. IGJ supervises compliance by suppliers and medical professionals and ensures that the management of healthcare institutions provides direction on this point.

IGJ's investigation

In 2025 IGJ carried out 14 inspections at 3 suppliers, 2 dental chains (cooperating dental practices), 3 independent dental (group) practices, 1 dental laboratory and 5 independently practising dentists (freelancers). Inspectors spoke with the management and/or the board of these organisations and businesses and assessed the agreements, related documents and financial records between the different organisations and businesses. They examined whether these complied with legislation and regulations and whether the financial relationships established were sufficiently transparent.

These inspections form part of the annual supervision of transfers of benefit, which each year covers different fields. All 14 organisations and businesses inspected are active in the dental field and were selected at random. The inspections took place in 2025.

Article 6 of the Medical Devices Act (Wmh), which governs transfers of benefit, applies to suppliers and users (medical professionals) of medical devices. Other parties, such as congress organisers or educational institutions, fall outside the scope of supervision under the Wmh. Inspectors nevertheless also reviewed documents belonging to parties outside that scope, which provided a full picture of how the dental sector applies the legislation and regulations.

What did we see?

The investigation identified the following areas of concern.

Service agreements (DVO)

What is a service agreement? In a service agreement (DVO), a supplier and a medical professional record what they have agreed, for example remuneration for lectures, consultancy activities or participation in research on medical devices.

What did IGJ see? The investigation focused on how remuneration for services, reimbursement of expenses and the services provided are described in service agreements, including whether they are specified in concrete terms. Remuneration must comply with the maximum hourly rates and conditions set by the Code of Conduct for Medical Devices Foundation (GMH). Inspectors also checked whether these agreements corresponded to the actual payments recorded in the financial administration requested. IGJ found that service agreements were not in place in all cases in which services were provided, while payments were in fact made to medical professionals. This does not comply with legislation and regulations.

Sponsorship

What is sponsorship? Sponsorship means a financial contribution provided by a supplier, directly or through an intermediary (legal) person, to a healthcare institution. Such contributions may be used for (non-)scientific research, professorships or scholarships, for example.

What did IGJ see? In some sponsorship cases IGJ found no sponsorship agreement. As a result, the financial relationship was insufficiently transparent and did not comply with the policy rule on transfers of benefit under the Wmh.

Where sponsorship agreements did exist, they were generally insufficiently transparent: it could not be traced where the sponsorship funds were spent, including payments made to medical professionals.

Gifts

What is a gift? A gift is something of value given by a supplier to a medical professional.

What did IGJ see? IGJ established that suppliers rarely offer gifts to medical professionals in the dental sector. The administrative records showed no entries in the gift ledgers either. In one case involving a supplier, gifts had been provided. This does not comply with legislation and regulations.

Participation in events

What does participation in events mean? Suppliers are permitted to reimburse medical professionals for the costs of attending events (or meetings), or not to charge them.

What did IGJ see? IGJ established that suppliers did not pay or reimburse medical professionals for participation in events and meetings. Medical professionals stated that they bear the full cost of refresher and continuing education themselves.

Governance and translation into internal policy

What is governance? Governance concerns the management, operation and supervision of an organisation, aimed at responsible decision-making, transparency and reporting on policy to stakeholders. It covers the structures, rules and processes of an organisation's management, including the management of transfers of benefit.

What did IGJ see? The rules on transfers of benefit are laid down in Dutch law and are not derived from European law. IGJ found that internationally operating suppliers also apply international internal policies that are not fully aligned with Dutch legislation and regulations. IGJ has provided feedback to the organisations concerned and advised them to bring their internal policies, including codes of conduct, into line with Dutch law.

Overall picture: limited knowledge of legislation and regulations

The inspection interviews showed that suppliers and medical professionals are either unaware of, or only partially aware of, the current legislation and regulations on transfers of benefit (Article 6 Wmh). This is a clear point of concern for suppliers, medical professionals, and industry and professional associations.

It is also important to note that the rules are reciprocal: what a giver may not give, a recipient may not accept. In other words, once the law is breached, IGJ will take enforcement action against both parties.

Dialogue with stakeholder organisations

Before and after the inspections, IGJ discussed the prohibition on transfers of benefit with a number of suppliers and with industry and professional associations, including Indent, VGT and KNMT. IGJ has asked these organisations to raise further awareness of the legislation and regulations and of the way inspections are carried out among their members, because awareness in the sector and among its medical professionals is limited with regard to recent developments in transfers of benefit and to the assessment of consultation requests by the GMH code committee within that framework (self-regulation).

It is also noteworthy that industry and professional associations are not members of GMH, but have indicated to IGJ that they endorse the GMH Code of Conduct.

Limits of the Wmh scope

The investigation showed that the vast majority of the agreements concluded fell outside the scope of Article 6 Wmh on transfers of benefit. This is because the parties regulated by the law, namely the (legal) persons targeted by the legislation, did not fall within its definition. The agreements were concluded between medical professionals and suppliers other than medical device suppliers, for example educational institutions, scientific associations and congress organising companies, as well as suppliers registered abroad. This applies to service agreements, event agreements and sponsorship agreements.

What measures did IGJ take?

In short, some of the cases did not follow the current legal framework, namely in the areas of gifts and services. IGJ has therefore imposed administrative measures, including warnings and fines, on the suppliers and medical professionals concerned.

In addition, IGJ pointed out to a number of legal entities the areas in which they need to improve. These concern matters that must be recorded and safeguarded in the areas of sponsorship and governance in accordance with the law, the policy rule and the GMH Code of Conduct.

Transparency of financial relationships in healthcare matters: what happens next?

Maintaining dialogue. IGJ expects suppliers, healthcare institutions and medical professionals in the dental sector to act on the areas of concern set out above. To increase knowledge of the legislation and regulations on transfers of benefit, IGJ will continue its dialogue with suppliers, industry associations and professional associations on how to raise awareness in the dental field.

Supervision of transfers of benefit in 2026. Transfers of benefit in the medical device sector remain a focus area. In 2026 IGJ will visit cardiology, oral disease and maxillofacial surgery departments at a number of Dutch hospitals and private clinics to investigate the nature of financial relationships. Inspectors will review financial records, sponsorship contracts and service agreements between suppliers, medical professionals and healthcare institutions. Working arrangements between management and medical professionals will also be discussed.

IGJ does this because healthcare institutions and medical professionals must be able to select the medical device that is best for the patient, and not because money or gifts are available. If they, or suppliers, breach the rules, IGJ can take administrative measures.

See also

• Website: how to remain independent (hoeblijfikonafhankelijk.nl)
• Code of Conduct for Medical Devices (GMH), Article 13 on remuneration for services (gmh.nu)
• Medical Devices Act (wetten.overheid.nl)
• Policy rule on transfers of benefit under the Medical Devices Act (wetten.overheid.nl)
• Sub-reports: read the sub-reports of this investigation

AIMEILI Regulatory Interpretation

This IGJ report is addressed directly to the Dutch dental market, but the compliance risks it identifies are relevant to any Chinese medical device manufacturer planning to enter the Netherlands or the wider European Union. Suppliers operating in the Netherlands are expected to maintain a rigorous compliance system, in particular where financial dealings with medical professionals such as dentists and dental practices are involved.

Registration pathway

The Netherlands is an EU Member State, and CE marking under the EU Medical Device Regulation applies in the same way as elsewhere in the Union. Although the report focuses on commercial conduct around devices already on the market, transfers of benefit can indirectly affect the clinical evaluation and performance verification that underpin a registration file. If a supplier were to influence clinical study results through sponsorship or service agreements, the clinical data in the technical documentation could be called into question. All clinical investigations and performance verification should therefore be conducted independently and transparently, free of improper financial relationships.

Classification and technical documentation

Manufacturers should consider whether their dental devices involve co-development or training activities with medical professionals. Any arrangement involving a service agreement (DVO) or sponsorship must be supported by a written contract with clearly defined remuneration. IGJ noted that some agreements did not comply with the maximum hourly rates set by the GMH Code of Conduct. Companies cooperating with Dutch medical professionals should therefore draft terms by reference to the GMH Code and retain complete financial records.

Quality system and post-market maintenance

The report underlines the importance of governance and internal policy. IGJ found that the internal policies of internationally operating suppliers were not fully aligned with Dutch legal requirements. When establishing a representative or branch in the Netherlands, a company should ensure that its quality management system documentation, including ISO 13485 procedures, covers the management of transfers of benefit, with approval and record-keeping for gifts, sponsorship and service agreements. Post-market activities such as complaint handling and adverse event reporting should likewise be protected from financial relationships that could compromise independence.

Outlook for 2026

IGJ will extend its 2026 supervision to cardiology and oral and maxillofacial surgery. Supervision of transfers of benefit is therefore moving into additional specialty areas with greater inspection intensity. Even manufacturers whose products are not dental should review their cooperation models with Dutch medical professionals in advance and mitigate comparable risks. Appointing a local compliance adviser to review all financial dealings, and considering GMH membership or alignment with the GMH Code, can reduce enforcement exposure.

Business Impact: What Manufacturers Should Do

Regulatory information of this kind should not be read as general industry news. Companies should first determine whether it concerns legislation or policy, guidance or standards, product approval, recall or safety, quality systems or post-market supervision, because each category triggers different internal actions. Where a registration project for the relevant market is under way, the update should be entered in the target-market regulatory tracking log to confirm whether it affects product classification, the registration pathway, the applicant entity, local representative responsibilities or certificate maintenance.

Documents to review

• Intended purpose and classification rationale
• ISO 13485 quality management system certification and related procedures
• Risk management file
• Performance verification and testing reports
• Clinical evaluation or clinical evidence
• Labels and instructions for use, including localisation and language requirements
• Authorisation documents, mandates and existing registration certificates
• Service agreements, sponsorship contracts, gift registers and financial records relating to Dutch partners

Common risks

• Unclear classification rationale
• Incomplete evidence chains across the technical documentation
• Labels and instructions for use not localised for the target market
• Unclear responsibilities of the authorised representative
• Insufficient post-market maintenance arrangements
• Absent or non-compliant written agreements with medical professionals, and gifts that do not meet legal requirements

Recommended actions

• Record the official source link, publication date, applicable product scope and potentially affected areas in the regulatory tracking log.
• Have regulatory affairs, quality, R&D and sales jointly assess whether labels, instructions for use, clinical evaluation, risk management or test reports require updating.
• Where products are already marketed locally or applications have been submitted, assess whether the local representative, importer, distributor and after-sales team need to communicate, file changes, provide supplementary explanations or take post-market surveillance measures.
• Review cooperation models with Dutch medical professionals against Article 6 Wmh, the policy rule on transfers of benefit and the GMH Code, including maximum hourly rates and gift restrictions.
• Align international internal policies and codes of conduct with Dutch law before 2026 inspections begin.

For companies preparing multi-country registrations, the practical value of this update lies in understanding the boundaries of documentation re-use: the same CE, FDA, NMPA, ISO 13485 or MDSAP documentation may serve as core evidence in one country while requiring localised explanations, translated labels, authorised representative documents or a post-market maintenance plan in another. A short documentation gap review after each significant regulatory update helps avoid reactive corrections, changes or renewal difficulties later.

FAQ

Can the IGJ report of 22 June 2026 be used directly as a basis for an application?

No. This article supports preliminary understanding and project assessment only. A formal application must be based on the latest requirements of the target country's regulatory authority, the concluded classification of the product and the company's actual documentation.

What should a company do first after seeing an update of this kind?

Conduct a documentation gap assessment to determine whether the update affects the registration pathway, technical documentation, labelling, quality management system or post-market maintenance, and assign follow-up actions accordingly.

Does the report apply to manufacturers outside the Netherlands?

Yes, where they, or their Dutch representatives, distributors or agents, maintain financial relationships with Dutch medical professionals. Article 6 Wmh applies to suppliers and users of medical devices, and IGJ has explicitly noted that internationally operating suppliers must align internal policies with Dutch law.

Are all agreements with dental professionals covered by the Wmh?

No. IGJ found that most agreements fell outside the scope of Article 6 Wmh because the counterparties, such as educational institutions, scientific associations, congress organisers or suppliers established abroad, are not the legal persons targeted by the law. Agreements with medical device suppliers and medical professionals are, however, within scope and must comply.

Content Review and Scope of Application

Author: AIMEILI Regulatory Editorial Team. Professional review: AIMEILI Medical Device International Registration Project Team. Source principle: priority is given to official regulatory authorities, international organisations, standards bodies and publicly available legislation; industry media and project experience are used only as supporting judgement. Scope: this article supports preliminary understanding, documentation preparation and project planning and does not replace the formal requirements of the target country's regulatory authority, test conclusions or legal advice.

Further Reading

• 1 July 2026: Swissmedic requires medical devices and IVDs to be registered in swissdamed
• 25 June 2026: SAHPRA publishes mailing list for the medical device and IVD industry
• 10 March 2026: Singapore HSA becomes the first regulator worldwide to reach WHO Maturity Level 4 (ML4) for medical device regulation
• 1 June 2026: Four EUDAMED modules become mandatory from 28 May 2026
• 15 July 2026: Health Canada advances modernisation of drug and medical device review
• 11 May 2026: MHRA consults on reform of UK pre-market medical device regulation

Need to assess a registration pathway? Provide the product name, intended use, target countries and existing documentation base, and AIMEILI can help determine the registration pathway, documentation gaps and compliance risks.