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What is CE Mark
Medule A : Internal production control
Covers both design and production
The manufacturer himself ensures the conformity of the products to the legislative requirements (no EU-type examination)
Medule B : EU-type examination
Covers design
It is always followed by other modules by which the conformity of the products to the approved EU-type is demonstrated. A notified body examines the technical
design and or the specimen of a type and verifies and attests that it meets the requirements of the legislative instrument that apply to it by issuing an EU-type
examination certificate. There are 3 ways to carry out EU-type examination: 1) production type, 2) combination of production type and design type and 3) design type.
Module C : Conformity to EU-type based on internal production control
Covers production and follows module B
Manufacturer must internally control its production in order to ensure product conformity against the EU-type approved under module B
Module D : Conformity to EU-type based on quality assurance of the production process
Covers production and follows module B
The manufacturer operates a production (manufacturing part and inspection of final product) quality assurance system in order to ensure conformity to EU-type. The notified body assesses the quality system.
Module E : Conformity to EU-type based on product quality assurance
Covers production and follows module B
The manufacturer operates a product quality (=production quality without the manufacturing part) assurance system for final product inspection and testing in order to ensure conformity to EU-type. A notified body assesses the quality system. The idea behind module E is similar to the one under module D: both are based on a quality system and follow module B. Their difference is that the quality system under module E aims to ensure the quality of the final product, while the quality system under module D (and D1 too) aims to ensure the quality of the whole production process (that includes the manufacturing part and the test of final product). E is thus similar to module D without the provisions relating to the manufacturing process.
Module F : Conformity to EU-type based on product verification
Covers production and follows module B
The manufacturer ensures compliance of the manufactured products to approved EU-type. The notified body carries out product examinations (testing of every product or statistical checks) in order to control product conformity to EU-type. Module F is like C2 but the notified body carries out more systematic product checks.
Module G : Conformity based on unit verification
Covers both design and production
The manufacturer ensures compliance of the manufactured products to the legislative requirements. The notified body verifies every individual product in order to ensure conformity to legislative requirements (no EU-type).
Module H : Conformity based on full quality assurance
Covers both design and production
The manufacturer operates a full quality assurance system in order to ensure conformity to legislative requirements (no EU-type). The notified body assesses the quality system.