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 assesses the documentation and examines and tests the sample against the applicable harmonised standard; where the type meets the applicable requirements, it issues the EU type-examination certificate. For Category III, ongoing conformity assessment under 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 examines the technical documentation and carries out, or has carried out, the tests the applicable standard requires on the sample. Test reports the manufacturer already holds are part of the documentation: the body assesses which of them can be used (existing test reports). The certification decision is based on the applicable test results, the assessment of the technical documentation and the requirements of Regulation (EU) 2016/425. The body is impartial and gives no product-design advice on the product under assessment.
4. Certificate
Where the type meets the applicable essential health and safety requirements, the body issues the EU type-examination certificate, valid for five years at most. On that basis — and, for Category III, once Module C2 or D is in place — the manufacturer draws up the EU declaration of conformity and affixes the CE marking.
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. Any modification of the approved type or of its technical documentation that may affect conformity must be reported to the notified body that issued the certificate; it requires approval in the form of an addition to the certificate (Annex V, point 7.2). Before the certificate expires, the manufacturer asks for its review; where the type continues to meet the requirements, the certificate is renewed: certificate renewal and review.
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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