A notified body is an organisation designated by an EU member state to carry out conformity assessment of medical devices under the EU Medical Device Regulation or In Vitro Diagnostic Regulation, before a device can carry the CE mark.
Distinct from a certification body
A certification body audits your management system against a standard such as ISO 13485 and issues a certificate. Accredited by a national accreditation body.
A notified body performs regulatory conformity assessment for the EU market. Designated by a member state, listed in the EU’s NANDO database, and its role is set by regulation rather than by voluntary standards.
Many organisations act as both, which is why the terms get used interchangeably. The roles are different: one is voluntary certification, the other is a regulatory gate.
Why capacity matters commercially
The number of designated notified bodies fell sharply under MDR, and the resulting bottleneck has been a persistent industry problem. Lead times are a real project constraint — a device programme planned without confirming notified body availability can lose quarters waiting.
For US manufacturers
If you sell only in the United States, you do not need a notified body. FDA’s route is separate: QMSR compliance and the applicable submission pathway.
If you intend to sell into the EU, engage early. Notified bodies will review both your technical documentation and your quality system, and ISO 13485 certification is in practice expected even though the regulation does not name the standard.