What is a notified body in EU product law?

Dutch term: Aangemelde instantie / Notified Body | Legal basis: Decision 768/2008/EC

A notified body (aangemelde instantie) is an organisation designated by an EU member state to carry out third-party conformity assessment tasks under specific EU harmonised legislation. Notified bodies assess products that fall into higher-risk categories where the manufacturer's self-assessment alone is not sufficient.

Notified bodies are assessed and designated by national accreditation bodies (in the Netherlands: the Raad voor Accreditatie, RvA) and are notified to the European Commission through the NANDO database. Their activities include EU type-examination (module B), production quality system assessment (module D), and full quality assurance (module H). The notified body's opinion is binding for CE marking purposes.

Why it matters for international businesses

For manufacturers of higher-risk products (certain machinery, medical devices, pressure equipment, personal protective equipment), engaging the right notified body early in the product development cycle is essential for market access.