Conformity Assessment

Conformity Assessment is the overarching legal process used to demonstrate that a product meets the requirements of EU legislation before it is placed on the market. For North American manufacturers, it is helpful to view this as the "roadmap" to the CE Mark. The specific route you must take depends entirely on the risk level of your equipment.

For the vast majority of industrial machinery, the assessment procedure is Internal Production Control (often called Module A). This allows you to self-declare compliance after compiling a Technical File and performing a Risk Assessment. However, if your product is listed as High-Risk Machinery (Annex IV of the Directive or Annex I of the Regulation), you may be forced to use a stricter path.

These stricter paths involve a Notified Body and include procedures like Type Examination (Module B) or Full Quality Assurance (Module H). The new Machinery Regulation explicitly aligns these "Modules" with the New Legislative Framework, making it critical to identify the correct module early to avoid invalidating your Declaration of Conformity (DoC).