Regulation (EC) No 765/2008 defines conformity assessment as the process demonstrating whether specified requirements relating to a product, process, service, system, person or body have been fulfilled, and a conformity assessment body as a body that performs such activities, including calibration, testing, certification and inspection. Decision No 768/2008/EC repeats the definition and, in its Annex II, sets out the menu of procedures (“modules”) from which each product act chooses: from module A, internal production control carried out entirely by the manufacturer, through EU-type examination (module B) combined with production control, to full quality assurance (module H).
Which module applies depends on the legislation and the risk of the product. The Low Voltage Directive and RoHS rely on module A, so no third party is involved; other acts, such as the Radio Equipment Directive and the Toy Safety Regulation, require EU-type examination by a notified body in the cases they specify. The Ecodesign for Sustainable Products Regulation follows the same approach: each delegated act specifies the applicable procedure from module A in its own Annex IV or modules B to H1 of Decision 768/2008 (Article 4(5)).
For the manufacturer the outcome of the procedure is what allows it to draw up the EU declaration of conformity and affix the CE marking. Importers must verify that the manufacturer has carried out the appropriate procedure before placing a product on the market. Where a notified body has been involved, its identification number appears next to the CE marking and its certificate belongs in the technical documentation.