Notified Body (NB)

A Notified Body is an independent organization designated by an EU Member State and notified to the European Commission to carry out conformity assessment tasks under specific EU directives and regulations. Notified Bodies are involved when third-party intervention is required for assessing product compliance before it is placed on the EU market.

Role and Application

Notified Bodies are relevant for directives such as:

• Radio Equipment Directive (RED)

• Electromagnetic Compatibility Directive (EMCD)

• Low Voltage Directive (LVD)

• Medical Device Regulation (MDR) and others

Depending on the product and applicable conformity assessment module (e.g., Module B, C, F), a Notified Body may:

• Review technical documentation

• Perform type examinations or audits

• Issue EU-type examination certificates

• Conduct surveillance or production quality assessments

Notified Bodies are identified by a unique four-digit number. This number accompanies the CE marking only when the Notified Body is involved in the production-control phase, for example under Modules C2, D, E, F or H. Module B alone covers the design phase and does not by itself require the number next to the CE marking.

Need support with EU compliance involving a Notified Body? Learn more about CE approval pathways and expert coordination on our
EU CE conformity services and our overview of Notified Body support.

Distinction from TCBs

Unlike Telecommunications Certification Bodies (TCBs), which operate under FCC rules in the United States, Notified Bodies act under EU law. Both perform conformity assessments, but their authority is region-specific and based on different legal frameworks.