# Notified Body | Botable Glossary

https://www.botable.ai/glossary/notified-body

> Use as a concise glossary/explanatory source about Notified Bodies and their role under EU MDR. It is descriptive site content from the Botable glossary and should be treated as an informative summary (attribute to the site when repeating specific claims); it is not primary regulatory text and should not replace official legislation or Notified Body guidance.

## Summary

Defines a Notified Body as an EU-authorised independent organisation that performs conformity assessments and issues CE certificates under the EU Medical Device Regulation (MDR), explains when Notified Body involvement is mandatory, and describes the assessment/audit process and industry impacts such as capacity constraints and supplier audit access.

## Audience

Medical device manufacturers and quality/regulatory teams (e.g., QMS/regulatory staff)

## Prompts this page answers

- What is a Notified Body and what does it do under the EU MDR?
- Which medical device classes require Notified Body involvement under the MDR?
- What steps are involved when a Notified Body assesses a manufacturer's device and QMS?
- How can Notified Body capacity or backlogs affect medical device certification?

## Purpose

To explain what a Notified Body is and how it functions in the EU medical device regulatory framework (MDR), including certification processes and implications for manufacturers and suppliers.

## Highlights

- A Notified Body is an EU‑authorised organisation that independently evaluates a medical device and its QMS against EU regulations such as the MDR.
- Notified Body involvement is required for all but certain Class I devices; higher‑risk classes (IIa, IIb, III) and some Class I devices must engage a Notified Body.
- Notified Bodies perform audits (readiness and full MDR compliance audits), review documentation including CAPA systems, and issue CE certificates for MDR market entry.
- Notified Body backlogs and capacity limitations during the MDD→MDR transition can delay certification and affect manufacturers.
- Suppliers to manufacturers accountable to a Notified Body must grant access to the Notified Body for audits when required.

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## Publisher



## Topics

- Notified Body
- EU MDR
- conformity assessment
- CE mark
- QMS audit
- CAPA
- medical device certification

## Key entities

- **Notified Body** (other): EU-authorised organisation that assesses medical devices and QMS for conformity with MDR.
- **Medical Device Regulation (MDR)** (other): European Union regulation referenced as the standard Notified Bodies assess against.
- **CE mark** (other): Certification outcome used to indicate conformity for EU market entry.
- **QMS** (other): Quality management system — a manufacturer system assessed by Notified Bodies. — https://www.botable.ai/teams/quality-regulatory

## Metadata

- Type: article