Concept · Standards & Organisations
Notified body
An organisation designated by an EU member state to assess the conformity of certain products, such as medical devices above the lowest risk class, before they are placed on the EU market.
- Type
- Concept
- Domain
- Standards & Organisations, Compliance & regulation
Overview
In the EU the maker of a product declares its conformity, but for higher-risk products the law requires an independent check first. A notified body is the organisation that carries out that check, after being designated by a national authority and notified to the European Commission.
How it works
For medical devices, the route to market depends on the device class. For all but the lowest-risk devices, a notified body reviews the technical documentation, audits the maker's quality management system and issues a certificate if the device and the system conform.
The maker chooses a notified body designated for its type of device. After certification the body carries out surveillance audits, reviews significant changes and can suspend or withdraw a certificate.
Notified bodies exist under several EU laws, such as those for machinery and radio equipment, not only for medical devices.
Examples
- A review of a patient monitor's technical documentation.
- An audit of a device maker's design controls and supplier controls.
- Assessment of a significant design change after certification.
- A surveillance audit in the years after the certificate is issued.
Why it matters
Regulatory affairs teams plan the submission around the notified body's review, and quality teams host its audits. Its certificate, with the maker's declaration of conformity, lets the device carry the CE marking.
It matters most to: Audit and Certification Coordinator, Certification Program Manager, Quality Systems Manager
Common confusions
- Not the same as Competent authority
- A competent authority is the national regulator; it designates and monitors notified bodies but does not usually certify devices itself.
- Not the same as Accredited test laboratory
- A laboratory runs type tests and issues reports; the notified body assesses conformity and issues the certificate.
Related standards
- ISO 13485 (quality management systems for medical devices)
Sources
- Notified bodies (opens in a new tab), European Commission, Internal Market, Industry, Entrepreneurship and SMEs, 2026-11-10
- Medical Devices, New regulations (opens in a new tab), European Commission, Public Health, 2026-11-10
- EC Designates Third Notified Body Under MDR (opens in a new tab), Regulatory Affairs Professionals Society (RAPS), Regulatory Focus, 2026-11-10
Related terms
Part of the Standards & Organisations glossary, with every term in the topic and the lifecycles, tools and standards that use them.
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Last reviewed . Written by The Semiconductor Hub editorial team. The full glossary