---
title: "The EU Notified Body Process: What Every Non-EU Manufacturer Should Know"
description: "Understand the EU Notified Body process for medical devices, from selection to review timelines and common delays under the MDR."
url: https://qbdgroup.com/en/blog/eu-notified-body-process-medical-devices
type: "Blog post"
language: en
published: 2026-04-29
author: "Anne-Sophie Grell & Petra De Geest"
category: "Regulatory Affairs"
publisher: "QbD Group"
citation: "QbD Group, \"The EU Notified Body Process: What Every Non-EU Manufacturer Should Know\", https://qbdgroup.com/en/blog/eu-notified-body-process-medical-devices"
---
# The EU Notified Body Process: What Every Non-EU Manufacturer Should Know
> Understand the EU Notified Body process for medical devices, from selection to review timelines and common delays under the MDR.

One of the most fundamental differences between the EU and other regulatory systems is the role of the **Notified Body (NB)**. While the FDA and NMPA act as centralized government authorities that directly approve medical devices, the EU relies on independent third-party organizations designated by EU Member States within a defined scope. The list of NBs can be found in the NANDO database.

**In this blog, we explain how the Notified Body process works and what non-EU manufacturers need to consider to avoid delays and misalignment.**

## What the Notified Body Does

Notified Bodies (NBs) are responsible for:

- Interpreting MDR requirements within their designated scope
- Assessing whether the manufacturer's evidence demonstrates **safety, performance, and an acceptable benefit–risk profile**
- Evaluating the coherence of technical documentation, clinical data, and regulatory strategy
- Conducting conformity assessments for most medical devices (except certain Class I devices)
- Performing periodic and unannounced audits
- Issuing CE certificates prior to market access
- Conducting ongoing surveillance after certification

Because of this broad mandate, the relationship with the NB extends across the **entire lifecycle** of the device. This is not a one-time review, but an ongoing partnership that directly impacts the ability to maintain market access.

## Selecting the Right Notified Body

Selecting an appropriate NB is a **critical early step**. The chosen NB must cover both the scope of the product portfolio and the Quality Management System (QMS). The selection process can be lengthy and should be initiated in parallel with product development and QMS implementation.

Early engagement allows manufacturers to clarify expectations, align on documentation requirements and templates, and identify potential gaps before formal submission.

## Review Timelines: No Guaranteed Deadlines

Unlike the FDA, NBs **do not operate under legally defined review timelines**. CE marking timelines depend on multiple factors, including:

- The quality, structure, and clarity of the submitted documentation
- The completeness of the GSPR checklist
- The availability and capacity of NB experts
- The type and complexity of the device
- Internal NB processes
- The need for additional audits (e.g. sterilization, microbiology)

Once the formal review begins, assessment of technical documentation typically takes **between 6 and 24 months**. The more complete and coherent the submission, the more predictable the timeline.

## Common Challenges That Cause Delays

Late engagement with an NB or misaligned submissions frequently lead to extended review cycles, additional information requests, and delays driven by limited NB capacity.

In more complex cases, this may result in:

- Restrictions on intended use or patient population
- Requirements for additional PMCF or clinical investigations
- Shortened certificate duration
- Rejection of the application

These outcomes are often linked to incomplete submissions or insufficient clinical evidence.

## From Approval to Ongoing Partnership

Engaging with a Notified Body is not a one-time milestone, but a **continuous process** that requires alignment, preparation, and proactive management.

Engage your NB early, ensure your documentation is complete and coherent, and treat the relationship as a strategic priority from the outset.

## Looking to Go Deeper?

Understanding the Notified Body process is only one part of achieving EU readiness. Many of the challenges discussed here, from documentation gaps to lifecycle alignment, are explored in more detail in our whitepaper.

*Download the QbD Group whitepaper ["Home Market Approval ≠ EU Readiness."](/en/whitepapers/home-market-approval-eu-readiness) to explore the key gaps and how to address them.*
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Source: https://qbdgroup.com/en/blog/eu-notified-body-process-medical-devices — © QbD Group. Quote freely with attribution and a link back.