← Glossary

Notified Body

An organization designated by an EU member state to assess the conformity of medical devices before they can be placed on the market. Notified Bodies conduct audits, review technical documentation, and issue CE certificates.

A Notified Body is a third-party organization accredited by an EU member state to perform conformity assessments under EU MDR. They review technical documentation, audit quality management systems, and issue CE certificates for Class IIa, IIb, and III medical devices.

Key facts

  • There are approximately 35 Notified Bodies designated under EU MDR (down from ~80 under MDD)
  • The reduction in Notified Bodies has created capacity constraints and longer review timelines
  • Notified Bodies conduct both scheduled and unannounced audits
  • Certificates are typically valid for 5 years, subject to annual surveillance audits

Related terms

EU MDR (Medical Device Regulation)CE MarkingRegulatory Compliance
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