Notified Body

What does a notified body do?

A notified body is involved when the applicable CE-marking conformity-assessment route requires independent third-party review. Depending on device class and route, it audits the manufacturer's quality management system, samples or assesses technical documentation, evaluates specified evidence and issues certificates. It also performs surveillance and recertification activities. The European Commission maintains the official list of designated notified bodies, including each body's four-digit identification number and designated scope.

Is a notified body a government agency?

Not necessarily. A notified body is a conformity-assessment organization designated and monitored by a national designating authority under EU law; organizations may have different ownership structures. It is not the manufacturer's regulatory consultant. Independence and impartiality requirements limit the advice it can give about the same device or quality system it will assess, so the manufacturer remains responsible for classification, evidence strategy and regulatory compliance.

How does a manufacturer choose one?

Designation scope comes first: the body must be designated under the MDR or IVDR for the relevant device and conformity-assessment codes. Manufacturers then evaluate capacity, experience, language, audit locations, subcontracting, application process and commercial terms. Timelines vary substantially with device complexity, dossier readiness, audit findings and the body's workload. Early engagement matters, but a generic promise that every first certification will take a specified number of months or years is not reliable.

What happens if designation or a certificate changes status?

Suspension, restriction or withdrawal of a notified body's designation can affect its ability to perform assessments and oversee certificates. The legal consequences depend on the status, the authority's measures and any available transition arrangements; a certificate does not simply transfer automatically because the manufacturer appoints another body. Manufacturers should verify certificate status in EUDAMED where available, coordinate promptly with the relevant bodies and authorities, and document supply and vigilance decisions. Our European Union market page places that dependency within the broader EU market sequence.