A notified body is an organization designated by a national authority to assess whether certain products meet the requirements of applicable legislation before they can be placed on the market or bear a conformity mark. In translation and localization, it appears in conformity assessment procedures, technical file submissions, audit correspondence, and declarations of conformity for medical devices and in vitro diagnostics.
Notified body references appear in CE marking documentation, technical file checklists, audit reports, certificates, and correspondence with manufacturers. Translators must keep the body’s name and identification number unchanged, and they must distinguish the notified body from the manufacturer, authorized representative, importer, and regulatory authority, especially in EU texts.
A common error is translating “notified body” as “regulatory authority” or “competent authority,” which confuses the conformity assessment role with market surveillance or public-health oversight. That can misstate who issued a certificate or reviewed a technical file, creating compliance and liability confusion in official documents and audit trails.
FDA, CE/MDR and NMPA reviewers assess the submitted wording itself. Regulatory bodies require traceable, accountable translation, and an inconsistent term can delay or fail a submission.
Angel Translation locks terms like this into a project terminology base before expert review begins, so the same source term resolves to the same target term across every document in a submission — and stays consistent in the next revision. See the 8-step AI + expert workflow.
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