The EU type-examination process, through the manufacturer's eyes
Technically reviewed: 2026-07-31
In short
EU type-examination (Module B) runs like this: the manufacturer submits the technical documentation and the type sample to a single, chosen notified body; the body examines the sample against the applicable harmonised standard and assesses the documentation; on a conforming result it issues the EU type-examination certificate. For Category III, ongoing production surveillance (Module C2 or D) is added.
1. Preparation — before submission
The manufacturer identifies the product’s category and the applicable harmonised standard, then compiles the technical documentation. This stage is in the manufacturer’s hands, and it usually decides how smoothly the procedure runs: complete, well-ordered documentation is the fastest route.
2. Application and type sample
The application goes to one chosen notified body. The type sample is a representative piece of what will actually be produced — not a prototype variant the series will later deviate from.
3. Examination and assessment
The notified body performs the standard’s tests on the sample and assesses whether the documentation supports conformity. The outcome rests solely on the examinations — the body is impartial and gives no product-design advice on the subject of the procedure.
4. Certificate
On a conforming result the body issues the EU type-examination certificate. On that basis the manufacturer affixes the CE marking and issues the EU declaration of conformity.
5. Afterwards: the responsibility for series production
The certificate covers the type. Keeping the series identical to the examined type is the manufacturer’s responsibility: through internal production control in Category II, and with notified body involvement (Module C2 or D) in Category III. At any material or construction change, the certificate’s validity for the changed product must be clarified.
How long does it take?
The biggest drivers of lead time sit on the manufacturer’s side: the completeness of the documentation, sample availability, and any modification rounds. The test programme’s length depends on the product’s complexity and the standard’s requirement count — better clarified at the first consultation, with the product on the table, than promised in the abstract.
Frequently asked questions
- Can the application go to several notified bodies?
- No. Under Regulation (EU) 2016/425, the EU type-examination application for a given type may be lodged with a single notified body of the manufacturer's choice.
- What does the technical documentation contain?
- The content per Annex III of the Regulation: the product's description and intended purpose, design and manufacturing drawings, the list of applied standards, the risk analysis, and the data needed for testing. Incomplete documentation is the most common cause of delay.
- What happens if the sample fails one requirement?
- The manufacturer is informed of the unmet requirement. The procedure can continue with a modified product and documentation — the certificate can only be issued once every applicable requirement is met.
Where next?
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