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Whether you need a notified body depends on the conformity assessment procedure that the EU rules for your product prescribe. For many products you assess and declare conformity yourself; for others an independent notified body must first examine the design, the production or each product. As a Dutch lawyer at MAAK Advocaten in Amsterdam, I help manufacturers outside the EU get this right before they apply.
Part of our overview of EU product law for companies selling into the Netherlands.
Where does conformity assessment fit before CE marking?
Conformity assessment is “the process demonstrating whether specified requirements relating to a product, process, service, system, person or body have been fulfilled” (Article 2, point 12, Regulation (EC) No 765/2008). For CE products it comes before the EU declaration of conformity and the CE marking.
Under the Low Voltage Directive, manufacturers first carry out the conformity assessment procedure or have it carried out, and only then draw up the EU declaration of conformity and affix the CE marking (Article 6(2), Directive 2014/35/EU). The Machinery Regulation has the same order (Article 10(2), Regulation (EU) 2023/1230). Those last steps: EU declaration of conformity.
EU law has no “CE certificate”; “CE certification” is everyday language. What exists is a procedure that, in some modules, includes a decision of a notified body, such as an EC-type examination certificate (Annex II, Module B, point 6, Decision No 768/2008/EC) or a quality system approval decision (Article 38(3), Regulation (EU) 2023/1230).
Products without harmonisation legislation need no module and no notified body; the General Product Safety Regulation asks for an internal risk analysis and technical documentation (Article 9 GPSR). See selling products in the EU from outside the Union.
Does your product need a notified body?
Only if the sector legislation for your product says so. That legislation selects one or more modules from Annex II to Decision No 768/2008/EC (Article 4(1)); where it lists several, you choose among them (for machinery: Article 25(2) and (3), Regulation (EU) 2023/1230).
The Decision itself places no obligations on your company. It is a model for the EU legislator, which weighs, for example, the nature of the risks and, where third-party involvement is mandatory, the need for the manufacturer to have a choice between quality assurance and product certification modules (Article 4(1)(b) and (c)).
Electrical equipment under the Low Voltage Directive goes through Module A, internal production control, without a notified body (Articles 6(2) and 15(2), Directive 2014/35/EU). Under the Machinery Regulation, whose Article 25 applies from 20 January 2027, the conformity assessment procedure depends on Annex I:
- category listed in Annex I, Part A: EU type-examination (Module B) followed by Module C, or Module H, or Module G, so always with a notified body (Article 25(2));
- category listed in Annex I, Part B: Module A only if the machine was designed and constructed in accordance with the harmonised standards or common specifications specific to that category covering all relevant essential health and safety requirements; otherwise B + C, H or G (Article 25(3));
- category not listed in Annex I: Module A (Article 25(4)).
More on the new Machinery Regulation (EU) 2023/1230.
| Module | Who assesses | When (example) | Source |
|---|---|---|---|
| A, internal production control | You alone, on your sole responsibility | Electrical equipment; machinery not in Annex I | Art. 6(2), 15(2) Dir. 2014/35/EU; Art. 25(4) Reg. 2023/1230 |
| A1, A2 | You, plus tests or checks by an accredited in-house body or under a notified body’s responsibility | Where the sector rules provide for it | Annex II, Art. R21 Dec. 768/2008 |
| B + C, D, E or F | Notified body examines the design (EC-type examination); then the production module | Machinery in Annex I, Part A: B + C | Annex II Dec. 768/2008; Art. 25(2)(a) Reg. 2023/1230 |
| G, unit verification | Notified body examines each product | Machinery in Annex I, Part A or B | Art. 25(2)(c), (3)(d) Reg. 2023/1230 |
| H, H1, full quality assurance | Notified body approves and monitors your quality system; H1 adds design examination | Machinery in Annex I, Part A or B: H | Art. 25(2)(b), (3)(c) Reg. 2023/1230 |
How do you choose a notified body?
Choose a body notified for your legislation, module and product, in any Member State, and apply to one only: the application includes “a written declaration that the same application has not been lodged with any other notified body” (Annex II, Module B, point 3).
A notified body is a conformity assessment body notified by a Member State (Article R23, Decision No 768/2008/EC). It must be “a third-party body independent of the organisation or the product it assesses” (Article R17(3)). It may not design or manufacture the products it assesses, nor engage in activities, in particular consultancy, that may conflict with its independence of judgement (Article R17(4)).
The Commission publishes the list of notified bodies, with their identification numbers and the activities for which they are notified (Article R24). Check there that the body covers your legislation, module and product (Article R23(3)). A body in the Netherlands is not required.
I work in three steps. One: read in your product rules which procedures they allow. Two: within those, choose what fits your production; for a manufacturer with a good quality system that is sometimes a different route than for a manufacturer that builds a single machine. Three: choose a body that is notified for exactly your rules and that procedure, and lodge your application with only one body at a time. My advice is to have the procedure and the documentation checked legally first, and only then to approach a body. A notified body assesses; it does not advise you on your design. A well-prepared application is how you prevent a refusal.
Can your authorised representative apply for you?
Yes, if the mandate says so. Your authorised representative “may lodge the application referred to in point 3 and fulfil the obligations set out in points 7 and 9, provided that they are specified in the mandate” (Annex II, Module B, point 10).
Points 7 and 9 cover reporting modifications and keeping the documents. The provision does not oblige you to appoint an authorised representative; if you work with one, put these tasks in the mandate expressly. More on the role: EU authorised representative in the Netherlands.
What does the notified body check, and when does it refuse?
The body assesses your technical documentation and, depending on the module, specimens, your quality system or each product. Where requirements are not met, “it shall require that manufacturer to take appropriate corrective measures and shall not issue a conformity certificate” (Article R27(3)).
In Module B, the body examines the documentation and specimens and carries out tests (point 4). Where the type does not satisfy the requirements, it “shall refuse to issue an EC-type examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal” (point 6). For machinery, Article 38(3) of Regulation (EU) 2023/1230 likewise bars the body from issuing an EU-type examination certificate, a quality system approval decision or a unit verification certificate where the requirements are not met, and requires corrective actions.
The body must work “in a proportionate manner, avoiding unnecessary burdens for economic operators”, but with “the degree of rigour and the level of protection required” (Article R27(2); Article 38(2) for machinery).
What goes wrong most often is that the technical documentation is not finished. A risk assessment is missing, or it is unclear which standards were applied in full and which only in part. The body then asks questions or refuses. My advice: before you apply, make a list of the requirements and show for each requirement how you meet it. That document helps you with the notified body and later with the market surveillance authority.
Preparing an application to a notified body, or facing questions from one? I can check your procedure and technical documentation before you apply: contact Martin Krüger, product law partner in the Netherlands.
What should you do if the notified body refuses or suspends your certificate?
Read the detailed reasons, correct what you can and ask the same body to reassess. If you disagree, appeal: for machinery the body must have a procedure (Article 39, Regulation (EU) 2023/1230); for other products the model requires the legislator to provide one (Article 4(7)).
First the facts. The body has to state the precise reasons. We read them together and make a correction plan: what can the manufacturer change, and where do we disagree? If it can be fixed, we fix it and ask for a new assessment. If we disagree, we use the appeal procedure that applies to the product; for machinery, the body must have one itself. We keep an eye on any time limit it sets. Until the certificate is there, the product does not go on the market. Moving to another body without fixing the cause does not help, because a refusal is shared with other notified bodies.
- Read the reasons: a refusal must give “detailed reasons” (Annex II, Module B, point 6).
- Make a correction plan: what you can change (the body requires “appropriate corrective measures”, Article R27(3)) and what you dispute. Correct and ask the same body to assess again.
- If you disagree, find out which appeal procedure applies to your product and note any time limit in it. For machinery, the body must ensure that “a transparent and accessible appeals procedure against its decisions is available” (Article 39, Regulation (EU) 2023/1230, since 20 January 2024); for other products, check how your product rules set up the procedure that Article 4(7) of the model requires.
- Do not change bodies to escape the refusal. Notified bodies report refusals to their notifying authority and to other notified bodies (Article R28; Module B, point 8), and a new application states that the same application has not been lodged elsewhere (point 3).
- Keep the product off the EU market until the required certificate is issued. Without the prescribed procedure there is no basis for the declaration of conformity and the CE marking (model: Article R2(2); for machinery from 20 January 2027: Article 10(2), Regulation (EU) 2023/1230), and market surveillance can act on missing or incorrect documents (model: Article R34).
The same steps apply after issue: if the product no longer complies, the body requires corrective measures and can suspend or withdraw the certificate; if they fail, it restricts, suspends or withdraws it (Article R27(4) and (5)). Which route is open after that appeal depends on the product rules and the body’s Member State; have it assessed before any time limit runs.
Does the certificate take over your responsibility as manufacturer?
No. “By affixing or having affixed the CE marking, the manufacturer indicates that he takes responsibility for the conformity of the product with all applicable requirements …” (Article 30(3), Regulation (EC) No 765/2008). The certificate is part of your file.
Even in modules with a notified body, the manufacturer “ensures and declares on his sole responsibility” that the products satisfy the requirements (for example Module H, point 1). For the old Medical Devices Directive 93/42/EEC, the Court of Justice held that the notified body’s involvement serves to protect end users, and that the conditions for its liability towards them are governed by national law (Case C-219/15, Schmitt, paragraph 60).
With the CE marking, you as manufacturer take responsibility for your product. The body checks what its procedure prescribes. That is why, after certification, I keep track of two things with manufacturers: changes to the product, which you must report to the body, and the documentation, which you must be able to show for years.
Modifications to an approved type that may affect conformity need additional approval (Module B, point 7). In the model, the manufacturer keeps the certificate with the technical documentation for 10 years after the product has been placed on the market (Module B, point 9); for the technical documentation and EU declaration of conformity, the Low Voltage Directive sets 10 years (Article 6(3)) and the Machinery Regulation “at least 10 years” (Article 10(3)). Check the periods in your own sector rules.
A product change that looks “small” is sometimes a new assessment for the body. Report a change once too often rather than once too little.
Example: a US machine builder whose application is refused
A refusal need not end the project: in the model the body must give detailed reasons (Annex II, Module B, point 6), and for machinery it requires corrective actions instead of issuing a certificate (Article 38(3), Regulation (EU) 2023/1230).
Suppose a US manufacturer will sell, after 20 January 2027, a machine whose category is listed in Annex I, Part A of the Machinery Regulation. It chooses Module B followed by Module C (Article 25(2)(a)). Its authorised representative in the Netherlands lodges the application, as its mandate provides, with a notified body in another Member State. The body does not issue the EU-type examination certificate: the risk assessment does not cover a part for which a harmonised standard was applied only in part. The manufacturer adds the missing assessment, asks the same body to reassess and keeps the machine off the EU market until the certificate is issued.
A hypothetical example, not one of our cases.
When do you need a Dutch lawyer?
Before you apply, while the procedure and the documentation are still open, and as soon as a notified body refuses, suspends or withdraws a certificate: an appeal procedure (for machinery, the body’s own under Article 39, Regulation (EU) 2023/1230) may set its own time limit.
At MAAK Advocaten, the first question I usually hear from a manufacturer is: “Do we need a notified body?” My first step is to turn that around: which EU product rules apply, and which conformity assessment procedure do those rules allow? For many products the manufacturer assesses and declares conformity itself. For others a notified body is required, and then you choose one that is notified for your legislation and procedure, in any Member State. Once that is clear, you know what to plan for.
We check the procedure and the technical documentation before you apply, draft the mandate of your authorised representative and the contract with your Dutch importer under Dutch law, and act for you when a notified body refuses, suspends or withdraws a certificate.
Frequently asked questions about notified bodies
Is there such a thing as a CE certificate?
Not as a legal term. “CE certification” is everyday language for the conformity assessment procedure. What exists in law are decisions of a notified body, such as an EC-type examination certificate or a quality system approval. The CE marking itself is affixed only by the manufacturer or its authorised representative (Article 30(1), Regulation (EC) No 765/2008).
Does a non-EU manufacturer need an EU notified body in the Netherlands?
No. You may choose a notified body in any Member State, as long as it is notified for your legislation, your module and your product. The Commission publishes the list of notified bodies with their identification numbers and the activities for which they are notified (Article R24, Decision No 768/2008/EC).
Can I apply to two notified bodies at the same time?
No. Under Module B, the manufacturer lodges the application “with a single notified body of his choice”, and the application includes a written declaration that the same application has not been lodged with any other notified body (Annex II, Module B, point 3, Decision No 768/2008/EC).
From when do the Machinery Regulation’s conformity assessment procedures apply?
Article 25 of Regulation (EU) 2023/1230 applies from 20 January 2027; until then Directive 2006/42/EC governs machinery. The rules on notified bodies, including the appeals procedure against their decisions in Article 39, have applied since 20 January 2024 (Article 54).
When should a non-EU manufacturer contact a Dutch lawyer?
Before lodging the application, when drafting the mandate of an authorised representative or the contract with a Dutch importer, and as soon as a notified body refuses, restricts, suspends or withdraws a certificate, so that any time limit for an appeal is not missed.
Primary sources
- Decision No 768/2008/EC on a common framework for the marketing of products, Article 4; Annex I, Articles R2, R17, R21, R23, R24, R27, R28 and R34; Annex II, Modules A to H1 (model for the legislator; no obligations on companies).
- Regulation (EC) No 765/2008, Article 2, point 12, and Article 30 (CE marking).
- Regulation (EU) 2023/1230 on machinery, Articles 10, 25, 38, 39 and 54.
- Directive 2014/35/EU (Low Voltage Directive), Articles 6 and 15.
- Court of Justice, 16 February 2017, Case C-219/15, Schmitt, paragraph 60.
Last checked on 5 November 2026 · next relevant date: 20 January 2027 (Machinery Regulation applies)
About to apply to a notified body, or has one refused or suspended your certificate? Put your situation to me through my page as product law partner in the Netherlands. — Martin Krüger
