Conformity Assessment Routes for Machinery (General) under EMC
Conformity assessment is the procedure by which manufacturers demonstrate their product meets the applicable essential requirements. The available routes — from self-declaration to Notified Body involvement — depend on the directive and the product risk class.
Available modules
The EU's modular approach to conformity assessment defines eight modules (A through H) ranging from internal production control (self-declaration) to full quality assurance with Notified Body involvement. Each directive specifies which modules are permitted for products within its scope.
When is a Notified Body required?
A Notified Body must be involved when the directive mandates it for the specific product type or risk class, when harmonised standards do not exist for the essential requirements at issue, or when the manufacturer elects to use a module that requires third-party involvement (e.g. Module B + C, E, F, G, or H).
Declaration of Conformity
At the end of the conformity assessment process the manufacturer signs the EU Declaration of Conformity (DoC). The DoC must identify the product, list all applicable directives and standards, identify any Notified Body involved, and be signed by an authorised representative.
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