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.
