§5.1.9 Rationale for selecting the appropriate modules

— The legislator should avoid modules too onerous for the objectives of the Union harmonisation legislation concerned, without however compromising the protection of the public interest. — The complexity of the modules selected should be proportional to the risk (impact on public interest, health, safety, environment) of the product, its design complexity, the nature of its production (large series vs small series, custom-made, simple vs complex production mechanism etc.). The legislator when selecting modules for his legislative instrument should follow the following principles: — As a general rule, products are subject to both design and production modules before placed on the market. — When appropriate in terms of protection of public interest, the manufacturer must be given as wide a choice of modules as possible. — If it is sufficient that the manufacturer carries out himself all checks in order to ensure the conformity of the products, then the legislator may select module A. This can be the case of low complexity (simple design and production mechanism) products that present a low risk for the public interest. — In cases of mass production based on a type/specimen and where the product in question is of complex design or presents higher risks of non-compliance for instance, the EU legislation may lay down the conformity assessment procedure in two steps: first the examination of conformity of the prototype/specimen against the relevant legal requirements (EU-type examination - module B) and then the determination of the conformity of the products against the approved EU-type (modules C and variants, D, E, F). — In cases where the legislator has opted for the demonstration of conformity assessment against a specimen (module B), he must examine the possibility of whether it is sufficient that the manufacturer can carry out himself all checks in order to ensure the conformity in the production phase. If this is the case, then the legislator may select module C. — In many cases the legislator must acknowledge that quite often, manufacturers manage very well equipped testing laboratories or premises. This is usually the case for new innovative complex products for which the testing know-how remains inside the manufacturers. In such cases the legislator may consider selecting either modules A1, A2, or, C1, C2 (the latter two, if he has opted for the demonstration of conformity assessment against a specimen - module B) that allow the use of an accredited in-house body. — If the demonstration of conformity of products against an approved EU-type cannot be left to the manufacturer but requires that products are supervised by a notified body during the production process, then the legislator may require from the manufacturer either to operate an approved quality system (modules D, E) or that the conformity of his products are verified be means of tests/checks (module F). In this respect, if the production mechanism is relatively ‘simple’ then the legislator may consider that it sufficient that the quality system of the manufacturer focuses only on the test of the final product without including the pure manufacturing part. If this is the case, module E is the most appropriate. — In the case of products of simple design but complicated production/manufacturing, the legislator may consider selecting modules D1, E1, F1 and using thus the advantages of modules D, E and F respectively, without the necessity of recurring to a more formal specimen examination (as provided under module B that precedes modules D, E, F). — For products, produced in small series the legislator may consider selecting module G. — If the manufacturer operates or has to operate a full quality system covering both the design and the production phase, the legislator may opt for module H. — When the manufacturer operates a full quality assurance system, but the verification of the conformity of design and the issuance of EU design examination certificate by a notified body is necessary, then the legislator may select module H1.

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Source: EUR-Lex (Cellar) · retrieved 2026-09-07