Notified body

A notified body is an independent organization designated by an EU member state to assess the conformity of devices that are not allowed to be self-certified.

Under the EU MDR, class I devices that are sterile, have a measuring function, or are reusable surgical instruments, and devices in higher classes, involve a notified body. The body audits the quality system and, depending on the conformity route, reviews technical documentation. It is not the competent authority and it is not your consultant. Its designation is limited to scopes you can look up in NANDO.

Preparation is an internal-audit problem as much as a writing problem. The notified body will sample CAPA, supplier control, clinical evaluation linkage, and whether procedures match the technical file. A QMS that cannot produce the record in the meeting becomes a nonconformity even when the underlying work was done.

HAVGATE is not a notified body and does not file submissions. It keeps the QMS records those assessments sample: audits, CAPA, documents, training and suppliers.