[Home](/)/[Resources](/resources)/EU type-examination (Module B) EUProcess guide # EU Type-Examination (Module B): The Notified Body Process Module B is not a complete conformity assessment route on its own — it only covers the design examination. It must always be combined with a production phase module (C, D, E, or F). The EU Type-Examination Certificate is the NB's statement that a specific product type meets essential requirements; the production module covers how the manufacturer ensures every unit produced matches the examined type. Copy Link[Share on WhatsApp](https://wa.me/?text=https%3A%2F%2Fkrono-labs.com%2Fguides%2Feu-type-examination-module-b) At a glance Module B process steps 6 Certificate contents 8 Directives requiring Module B 4 ## Module B process — step by step 01 ### Notified Body selection Select a NB notified for the specific directive and product category. Check NANDO (New Approach Notified and Designated Organisations) database at nando.ec.europa.eu. Confirm the NB's scope of notification covers your product type and the applicable directive. 02 ### Application and technical documentation submission Submit the application to the NB with complete technical documentation: product description, design drawings, circuit diagrams, Bill of Materials, risk assessment, list of harmonised standards applied, and any preliminary test results. 03 ### Technical documentation review The NB reviews the technical file to ensure it addresses all applicable essential requirements. The NB may request additional information or clarifications during this phase. 04 ### Examination of representative sample(s) The NB examines one or more representative product samples — either at the NB's facilities or at an accredited test laboratory. The NB determines which tests are required to verify conformity with applicable essential requirements. 05 ### Testing Tests are performed per applicable harmonised standards. The NB may perform tests directly, witness tests at a test laboratory, or accept test reports from accredited laboratories. The NB bears responsibility for the overall assessment regardless of who performs the tests. 06 ### EU Type-Examination Certificate issued If the product conforms to applicable essential requirements, the NB issues an EU Type-Examination Certificate (EUTEC). The certificate identifies: the product type, the NB, the standards applied, any conditions or restrictions, and the certificate validity. ## What the EU Type-Examination Certificate contains Certificate number — NB identification number + certificate sequence number Applicant name and address — the economic operator applying for the type examination Product description — model names, type designations, and product description identifying the certified type List of standards applied — harmonised standards used as the basis for the assessment Test reports referenced — accredited laboratory reports supporting the certificate Any special conditions or restrictions on use — limitations that must be reflected in the Declaration of Conformity Certificate validity period — typically 5 years, renewable on demonstration of continued compliance NB signature, stamp, and date ## Directives that require or permit Module B ### Machinery Directive 2006/42/EC Required for Annex IV machinery (circular saws, cartridge-operated fixing tools, guards for presses, etc.) when self-certification is not used. Mandatory for all Annex IV high-risk machinery unless no harmonised standard applies. ### Pressure Equipment Directive 2014/68/EU Required for category II equipment and above where production modules B+C2, B+D, B+E, or B+F apply. Also serves as the starting point for category III and IV equipment. ### PPE Regulation (EU) 2016/425 Required for Category II PPE (Module B+C) and Category III PPE. Not required for Category I PPE (self-certification). ### Radio Equipment Directive 2014/53/EU Optional for most products where harmonised standards cover essential requirements. Required where the manufacturer chooses not to apply harmonised standards — in this case Module B is combined with C, D, E, or H. ## Frequently asked questions ### How long is an EU Type-Examination Certificate valid? EU Type-Examination Certificates are typically valid for 5 years and renewable. However, the certificate remains valid only as long as the product conforms to the type described in the certificate. If the product is modified in a way that affects the certified type, the manufacturer must notify the NB. The NB will determine whether the modification requires a new assessment, a certificate supplement, or a new certificate. ### Can I choose any Notified Body for Module B, or must it be in the country where the product is manufactured? You can choose any Notified Body notified for the applicable directive and product category in any EU member state. There is no requirement to use a NB in your country of manufacture or the country of sale. The NB's four-digit identification number is listed on NANDO and must be included on the CE mark where NB involvement is required. ### If my product changes after Module B certification, what must I do? Inform your Notified Body of the change. The NB will assess whether the modification affects the product type covered by the existing certificate. Minor changes that do not affect compliance may be covered by a certificate supplement or addendum. Changes that affect compliance require a new or amended type examination. This is why product change control processes are essential once you have a Module B certificate — undocumented changes that come to light during market surveillance can invalidate the certificate retroactively. ### What is the difference between a Type-Examination Certificate and a test report? A test report from an accredited laboratory documents the results of specific tests performed on a product sample. A Type-Examination Certificate is a formal NB declaration that a product type has been examined and found to conform with applicable essential requirements. The certificate is a regulatory document with legal significance; a test report is technical evidence. Module B certification requires both: test reports supporting the findings, and the certificate attesting overall conformity. **Disclaimer:** Educational resource only. Notified Body selection and Module B application procedures vary by directive and NB. Always check the NANDO database for current NB notification scope before selecting a NB for your product. 🇪🇺 CE Marking roadmap for your product Every standard, document, and test that applies — free, no account required. See your free roadmap[ Want an expert to take your product through 🇪🇺 CE Marking compliance for you? One consultant from Krono's compliance team takes your product from requirements to legal sale, with a fixed quote before any work starts. 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