Notified Body
Quick facts
| Category | Independent conformity assessment organization |
|---|---|
| Used by | Medical device manufacturing and distribution within the European Union |
| Also called | None widely standardized |
| Related standards | EU MDR, ISO 13485 |
| Related processes | Product design controls, quality agreement, UDI, risk assessment |
| Semantic match | Notified Body, EU MDR conformity assessment, CE marking, medical device certification body |
What is Notified Body?
A Notified Body is an organization designated by an EU member state and recognized by the European Commission to perform conformity assessments under regulations such as EU MDR, verifying that a medical device meets the applicable General Safety and Performance Requirements before it can be legally marketed in the EU.
For most device classes, other than certain lower-risk devices that manufacturers can self-certify, engaging a Notified Body is a mandatory step. The Notified Body reviews the manufacturer's technical documentation, evaluates the quality management system, and may conduct on-site audits before issuing a certificate that allows the manufacturer to affix CE marking to the device.
Notified Bodies operate independently of the manufacturers whose devices they assess, providing the objective, third-party verification that gives regulators, healthcare providers and patients confidence in a device's safety and performance claims.
Why is Notified Body important?
Notified Body assessment is often the single most significant gating step in bringing a medical device to the European market, making the relationship between a manufacturer and its chosen Notified Body critical to product timelines.
Because Notified Body capacity has been constrained since EU MDR's introduction, with increased documentation demands and a limited pool of designated bodies, manufacturers need to plan conformity assessment timelines well in advance of target launch dates.
A Notified Body's independence provides assurance to healthcare systems and patients that device safety and performance claims have been objectively verified, rather than accepted solely on the manufacturer's own assertion.
How does Notified Body work?
A typical Notified Body engagement includes:
- Selection. Choose a Notified Body designated and scoped for the relevant device type.
- Application. Submit an application and technical documentation for review.
- Document review. The Notified Body evaluates technical documentation against applicable requirements.
- Quality system audit. The Notified Body may audit the manufacturer's quality management system.
- Certificate issuance. Upon successful assessment, the Notified Body issues a certificate supporting CE marking.
- Ongoing surveillance. The Notified Body conducts periodic surveillance audits to maintain certification validity.
Notified Body Assessment vs. Manufacturer Self-Certification
| Comparison | Notified Body Assessment | Manufacturer Self-Certification |
|---|---|---|
| Applies to | Most device classes | Certain lower-risk device classes only |
| Independent review | Required | Not required |
Real-world examples of Notified Body
A medical device manufacturer submits its technical documentation to a Notified Body designated for its specific device classification, beginning the conformity assessment process well ahead of its planned EU launch date.
A company managing a legacy device transitioning from the earlier Medical Device Directive works with its Notified Body to align documentation with current EU MDR requirements.
A manufacturer undergoes a Notified Body surveillance audit as part of maintaining its existing CE marking certification, demonstrating continued compliance since the original assessment.
Regulations and standards related to Notified Body
Notified Bodies are designated by individual EU member states and recognized at the EU level, operating under oversight from the European Commission and the Medical Device Coordination Group, performing conformity assessments specifically required under EU MDR and related EU regulations.
Manufacturers should confirm that a prospective Notified Body is specifically designated for the device type and classification relevant to their product, since designation scope can vary between different Notified Bodies.
Required by
How QT9 helps with Notified Body
QT9 QMS capabilities supporting Notified Body engagement
- Manage technical files, risk, CAPAs, audits and training in one platform.
- Support efficient creation, version control and approval workflows for traceable documentation.
- Centralize UDI, labeling and post-market surveillance data for technical file review.
- Maintain audit-ready records supporting Notified Body assessments and surveillance audits.
- Track certificate status and renewal timelines.
- Integrate quality data across design, production and post-market activities.
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Common mistakes with Notified Body
Common mistakes include underestimating Notified Body assessment timelines, particularly given increased documentation scrutiny and constrained Notified Body capacity since EU MDR's implementation.
Other problems include selecting a Notified Body without confirming its specific designation scope covers the manufacturer's device type and classification.
Frequently asked questions
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