Notified Body
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
A Notified Body is an organization designated by an EU member state and monitored by the European Commission and other member states to assess the conformity of medical devices against MDR requirements before they may carry the CE mark. For all but the lowest-risk device classes, a Notified Body’s conformity assessment — not a government agency’s premarket approval — is the gateway to the EU market.
Notified Bodies are private or quasi-private organizations — not government agencies — designated under a defined scope of device types and conformity assessment procedures, and subject to re-assessment, joint assessment by other member states, and Commission oversight. Under MDR, the designation criteria and ongoing monitoring were substantially tightened compared to the prior Medical Device Directive regime, which sharply reduced the number of active Notified Bodies.
A manufacturer selects a Notified Body designated for its device’s type and risk class, and that body issues and maintains the CE certificate underpinning the device’s EU market access — including periodic surveillance audits and re-certification, and unscheduled audits where the Notified Body has cause for concern.
- —Designated and monitored under EU MDR Articles 35–50, not a government regulator itself
- —Assesses conformity for all but self-certifiable, lowest-risk device classes
- —MDR tightened designation criteria, sharply reducing the number of active Notified Bodies
- —Conducts periodic surveillance audits and can trigger unscheduled audits
EU MDR 2017/745 Articles 35–50; Regulation (EC) No 765/2008 (accreditation and market surveillance framework)
Frequently asked questions
What is Notified Body?
A Notified Body is an organization designated by an EU member state and monitored by the European Commission and other member states to assess the conformity of medical devices against MDR requirements before they may carry the CE mark. For all but the lowest-risk device classes, a Notified Body’s conformity assessment — not a government agency’s premarket approval — is the gateway to the EU market.
Which regulations cover Notified Body?
EU MDR 2017/745 Articles 35–50; Regulation (EC) No 765/2008 (accreditation and market surveillance framework)