Notified Body

A Notified Body is an independent organization designated by an EU Member State to assess whether a product meets specific legislative requirements. Unlike standard Third-Party Testing facilities, these bodies hold official government-delegated authority to conduct conformity assessments for products that present higher safety risks. For North American manufacturers exporting to Europe, understanding when to engage a Notified Body is a critical step in the compliance roadmap.

While the majority of industrial machines allow for Self-Certification via internal checks, specific categories classified as High-Risk Machinery (such as presses, saws, or vehicle hoists) often require the mandatory involvement of a Notified Body. This process typically involves an EC Type Examination, where the body verifies that the technical design strictly adheres to Harmonized Standards and Essential Health & Safety Requirements (EHSRs).

Once the Notified Body validates your Technical File and quality systems, they issue a formal certificate. This independent validation is a strict prerequisite for signing the Declaration of Conformity (DoC) and legally affixing the CE Mark. Without this external approval, high-risk equipment cannot be placed on the EU market.