CE Marking Enforcement in the Netherlands

Published on 12 January 2023 · Last updated 25 October 2026

CE marking is not a certificate. By affixing it, the manufacturer declares that the product meets the EU harmonisation legislation that requires the marking (Article 30(3) Regulation (EC) No 765/2008). In the Netherlands, a misleading or unauthorised CE marking is prohibited under a decree based on the Commodities Act (Warenwet). It can lead to a fine, a withdrawal or a recall.

In this blog, our Dutch product compliance lawyers inform you about the most important aspects of CE Marking Enforcement in the Netherlands.

What is CE Marking, and Why is it Important in the Netherlands?

The CE marking is defined in Article 2(20) of Regulation (EC) No 765/2008. Only the manufacturer or its authorised representative may affix it (Article 30(1)). It may only be affixed to products for which specific EU harmonisation legislation requires it, and to no other product (Article 30(2)). By affixing it, the manufacturer takes responsibility for the product’s conformity (Article 30(3)). The CE marking is therefore not a certificate issued by an authority or a testing body.

Manufacturers and distributors in the Netherlands need to understand why CE Marking matters, as it is a key indicator of a product’s compliance with EU legislation. Fines the authority can impose are set out in enforcement and administrative fines by the NVWA.

What are the key aspects of CE marking?

• Legal framework: CE marking is governed by EU law. The general rules are in Article 30 of Regulation (EC) No 765/2008. The product-specific legislation says whether a product needs the marking and which procedure applies. That legislation builds on the reference provisions of Decision No 768/2008/EC, which itself imposes no obligations on businesses.
• Product categories: examples are machinery (Machinery Directive 2006/42/EC; from 20 January 2027 the Machinery Regulation (EU) 2023/1230), personal protective equipment (Regulation (EU) 2016/425), electrical and electronic equipment (including the RoHS Directive 2011/65/EU) and medical devices.
• Responsibilities: only the manufacturer or its authorised representative affixes the CE marking (Article 30(1) Regulation 765/2008). Importers and distributors check that the marking and the required documents are present (reference provisions R4 and R5 of Decision 768/2008/EC, as taken over in the product-specific legislation).

What are the consequences of non-compliance?

Non-compliance with CE marking requirements can lead to severe legal implications in the Netherlands. These may include:

Potential Actions by Dutch Authorities

• Corrective action: the market surveillance authority can require the business to bring the product into conformity, stop making it available, withdraw or recall it, destroy it, or add warnings (Article 16(3) Regulation (EU) 2019/1020). If the business does not act, the authority itself ensures a withdrawal or recall, or prohibits the product (Article 16(5)).
• Enforcement order: the Dutch minister can impose an order subject to administrative enforcement (last onder bestuursdwang) (Section 32 Commodities Act).
• Administrative fine: an incorrect or misleading CE marking breaches Article 30(1), (2) or (5) of Regulation 765/2008, which Dutch law prohibits (Section 2(3) of the Commodities Act Decree implementing the GPSR and the accreditation regulation). The fine is set by an annex (Section 32a Commodities Act). Under the version in force since 7 August 2026, it is €525 for a business with 50 or fewer employees and €1,050 for a business with more than 50 employees. For a business with a turnover of at least €10 million, a fine of 1% (intent) or 0.5% (gross negligence) of the annual turnover is possible instead, up to the sixth-category fine of Section 23(4) Dutch Criminal Code (Sections 2 and 3 and annex item B-1.2 of the Commodities Act Administrative Fines Decree). The fine can be increased if the business was fined earlier for a similar violation, less than two years have passed since that earlier fine became final, and the seriousness of the violation, the degree of culpability or the circumstances justify it (Section 3(4) of that decree).
• Exceptions to the fine: an administrative fine is not possible where an intentional or reckless violation causes a direct danger to human health or safety, or where the economic gain from the violation clearly exceeds the fine (Section 32a(3) Commodities Act).
• Dangerous consumer products: for products under the General Product Safety Regulation (EU) 2023/988, the minister can order a business that fails to act to withdraw or recall a dangerous product. Not complying with that order is a criminal offence (misdrijf) (Section 32h Commodities Act).

Which authority acts depends on the product. Under the Commodities Act, supervision lies with officials designated by the minister (Section 25(1)). For radio equipment, the Dutch Authority for Digital Infrastructure (RDI) has been designated (designation decree, Section 1). For many consumer products, the Netherlands Food and Consumer Product Safety Authority (NVWA) is the authority businesses deal with.

How does the CE marking procedure work?

The manufacturer is responsible for making sure the product meets the requirements of the applicable legislation. Under reference provision R2(2) of Decision 768/2008/EC, as taken over in the product-specific legislation, the steps follow this order:

Steps for Manufacturers

1. Conformity assessment: carry out the procedure that the product legislation prescribes. Depending on the product, the manufacturer does this alone or with a notified body.
2. Technical documentation: draw up the documentation that shows the product meets the requirements, and keep it for ten years (for example Article 10(3) Machinery Regulation, Article 8 PPE Regulation, Article 7 RoHS Directive).
3. EU declaration of conformity: once conformity has been demonstrated, draw up the declaration. With it, the manufacturer takes responsibility for the product’s compliance (R10). Under the Machinery Directive it is still called the EC declaration of conformity.
4. Affixing the CE marking: only then affix the marking, visibly, legibly and indelibly, before the product is placed on the market (R12).

Which role do distributors and importers play?

• Verification Duties: Checking the presence of CE marking and supporting documentation.
• Compliance Checks: For products imported from outside the EU.

Before placing a product on the market, an importer checks that the conformity assessment has been carried out, that the technical documentation is available, and that the product bears the CE marking and comes with the required documents. If there is a risk, it informs the manufacturer and the market surveillance authorities (R4). A distributor checks the marking, the documents and the language of the instructions, and informs the authorities if there is a risk (R5). An importer or distributor that sells a product under its own name or brand, or modifies it, is treated as the manufacturer (R6).

For many products, a business established in the EU must also be available to the authorities: it checks that the declaration of conformity and the technical documentation are available, provides information and cooperates on corrective action (Article 4 Regulation 2019/1020, for the legislation listed in Article 4(5)). For consumer products under the GPSR, Article 16 GPSR contains a similar rule.

When is a notified body involved?

Certain products require assessment by a notified body. That is a conformity assessment body which a member state has notified to the European Commission and the other member states (R13 Decision 768/2008/EC); it is not appointed by the EU. Examples: from 20 January 2027, machinery listed in Part A of Annex I to the Machinery Regulation always requires a notified body (Article 25(2)). PPE in category III requires EU type-examination plus module C2 or D (Article 19 PPE Regulation). If a notified body is involved in the production control phase, its identification number is placed next to the CE marking (R12).

Criteria for Notified Body Assessment

• Product Categories: Identifying if a product needs NoBo testing.
• Legislation Compliance: Adhering to relevant laws and standards.

What applies specially to medical devices?

Medical devices encompass a wide range of instruments and apparatus used in healthcare. Compliance with CE standards for these devices is crucial.

Understanding Medical Devices

• Range of Products: From simple tools to complex surgical devices.
• Regulatory Compliance: Ensuring all medical devices meet CE requirements.

Frequently asked questions about CE marking enforcement in the Netherlands

What happens if a product does not meet the CE marking rules in the Netherlands?

The market surveillance authority can require you to bring the product into conformity, withdraw or recall it, or have it destroyed (Article 16(3) Regulation 2019/1020). Affixing a CE marking that is misleading, or affixing it to a product that does not need it, is prohibited (Article 30(2) and (5) Regulation 765/2008; Section 2(3) of the Dutch implementing decree). Under the Commodities Act, the fine for this is €525 or €1,050 depending on the number of employees, or a turnover-related fine for large businesses (annex item B-1.2 Commodities Act Administrative Fines Decree).

What must a manufacturer do before affixing the CE mark?

The manufacturer carries out the conformity assessment the legislation prescribes (with a notified body where required), draws up the technical documentation, and then draws up the EU declaration of conformity. Only after that does it affix the CE marking (R2(2) Decision 768/2008/EC).

Are medical devices subject to specific CE marking rules?

Yes. Medical devices have their own CE marking requirements to ensure safety and compliance with health standards. Electrical and electronic medical devices are also covered by the RoHS Directive: since 22 July 2014, and in vitro diagnostic medical devices since 22 July 2016 (Article 4(3) Directive 2011/65/EU), and for the four phthalates added by Delegated Directive (EU) 2015/863 since 22 July 2021. Active implantable medical devices are excluded from RoHS (Article 2(4)).

Is there a CE certification or CE marking agency in the Netherlands?

No authority issues CE marks. The manufacturer affixes the marking itself and takes responsibility for conformity (Article 30(1) and (3) Regulation 765/2008). Only where the product legislation requires it does a notified body assess the product, for example through EU type-examination of PPE in categories II and III (Article 19 PPE Regulation). Notified bodies are notified by a member state, not appointed by the EU (R13 Decision 768/2008/EC).

Do food products or food processing equipment need CE marking?

Food itself does not carry a CE marking: the marking may only be affixed where specific EU harmonisation legislation requires it (Article 30(2) Regulation 765/2008). Food processing equipment is different. A machine must meet the Machinery Directive 2006/42/EC before it is placed on the market or put into service, including the declaration of conformity and the CE marking (Article 5(1)). From 20 January 2027 the Machinery Regulation (EU) 2023/1230 applies. Machines placed on the market before that date in conformity with the Directive may still be made available (Article 52).

Primary sources

• Regulation (EC) No 765/2008: Articles 2(20) and 30; Decision No 768/2008/EC, Annex I, reference provisions R2, R4, R5, R6, R10, R12 and R13
• Regulation (EU) 2019/1020 on market surveillance, Articles 4 and 16
• General Product Safety Regulation (EU) 2023/988, Article 16
• Machinery Directive 2006/42/EC, Article 5(1); Machinery Regulation (EU) 2023/1230, Articles 10(3), 25(2), 52 and 54
• PPE Regulation (EU) 2016/425, Articles 8 and 19; RoHS Directive 2011/65/EU, Articles 4(3) and 7; Delegated Directive (EU) 2015/863
• Dutch Commodities Act (Warenwet): Sections 25, 32, 32a, 32b and 32h
• Commodities Act Decree implementing the GPSR and the accreditation regulation (Warenwetbesluit uitvoering verordening algemene productveiligheid en verordening inzake accreditatie), Section 2
• Commodities Act Administrative Fines Decree (Warenwetbesluit bestuurlijke boeten), Sections 2 and 3 and annex item B-1.2; Dutch Criminal Code, Section 23(4)
• Decree designating supervisors for general product safety in the field of Economic Affairs (radio equipment), Section 1

Sources checked on 25 October 2026.

Contact our Dutch CE marking lawyers

If you have any questions or require legal assistance on CE Marking Enforcement in the Netherlands, please don’t hesitate to reach out to our knowledgeable and dedicated team at our Dutch law firm.