Module B (EC-type examination) covers only the product’s design phase, and it specifies the need for third-party conformity assessment, i.e. notified body. The notified body will need to examine the product’s technical design and, afterwards, verify and attests, by issuing an EC-type assessment certification, that all legislative requirements applicable to the product are met.
This specific conformity assessment module is a bit tricky because it’s always followed by another assessment module by which the product’s conformity to the approved EC-type can be demonstrated.
The EC-type examination may be carried out any of the following ways:
- Examination of a specimen of the complete product;
- Assessment of the adequacy of the product’s technical design through inspection of the technical documentation and any other supporting evidence plus examination of samples of at least one critical part of the product;
- Assessment of the adequacy of the product’s technical design through an examination of the technical documentation and any other supporting evidence, without inspection of a specimen.
The flexibility provided by Module B is well known because the examination stage could include only the technical file and/or critical parts of the product’s sample. Moreover, the module is uniquely designed to provide adequate flexibility in cases when a relevant practice, where the inspection of a specimen is not either economically viable or necessary, needs to be recognised.
If module B takes part in a product’s CE marking process, the manufacturer of the particular product doesn’t have the right to draft a Declaration of Conformity at this stage of the CE marking process or affix the notified body’s identification number to the product.