Notified body

Notified bodies are accredited and designated for defined scopes of legislation and product types; a body notified for one regulation is not automatically authorised for another. Their involvement is required for certain conformity assessment routes under the CRA, particularly for important products of class II and for critical products where a specific certification scheme applies.

What engagement typically involves

• Submission of technical documentation covering design, risk assessment and vulnerability handling processes.
• Review, and often testing, against the applicable essential requirements and any relevant harmonised standards.
• Issue of a certificate or assessment opinion referenced in the declaration of conformity.
• Ongoing obligations, such as notifying the body of substantial changes to the assessed product.

Because notified body capacity for the CRA is still building out, manufacturers whose products fall into routes requiring notified body involvement benefit from engaging early, both to secure a slot and to understand documentation expectations before the technical file is finalised.

A notified body assessment does not replace the manufacturer's own conformity work; it reviews and, where applicable, certifies it. The manufacturer remains responsible for the underlying engineering.