Updated July 2026
MDR notified bodies are conformity assessment bodies designated to perform specific activities under Regulation (EU) 2017/745 on medical devices.
They play a central role in the CE marking pathway for many medical devices, particularly when the applicable conformity assessment procedure requires the involvement of an independent third party.
This guide explains, for informational purposes, what MDR notified bodies are, when they may be involved, and where to find the updated official list.
In this guide
- What are MDR notified bodies?
- When may an MDR notified body be involved?
- What does a notified body assess?
- Where to find the official list of MDR notified bodies
- What information is available in NANDO?
- Why this guide does not provide a complete list
- Notified bodies, certificates and EUDAMED
What are MDR notified bodies?
A notified body is an organisation designated by an EU Member State to perform conformity assessment activities under the applicable legislation.
In the medical device sector, notified bodies must meet specific requirements relating, among other aspects, to organisation, quality, competence, resources and processes. The European Commission explains that these requirements are assessed by the national authorities responsible for notified bodies, with the involvement of European experts.
In the context of the MDR, the notified body assesses whether the manufacturer and the device meet the applicable requirements within the relevant conformity assessment procedure.
When may an MDR notified body be involved?
The involvement of a notified body depends on the risk class of the device and the applicable conformity assessment procedure.
The MDR provides that devices are classified into four classes: I, IIa, IIb and III. Classification depends on the intended purpose of the device and the associated risks, and is carried out according to the rules set out in Annex VIII of the Regulation.
In general, higher-risk devices require a greater level of notified body involvement. For many class IIa, IIb and III devices, the conformity assessment procedure involves a notified body.
Some class I devices may also require the involvement of a notified body for specific aspects, for example devices placed on the market in sterile condition, devices with a measuring function, or reusable surgical instruments, according to the provisions of the Regulation.
What does a notified body assess?
The activities performed by the notified body depend on the type of device, the risk class and the applicable conformity assessment procedure.
Depending on the case, a notified body may assess aspects such as:
- the manufacturer’s quality management system;
- technical documentation;
- correct classification of the device;
- applicable conformity assessment procedure;
- preclinical and clinical evidence;
- general safety and performance requirements;
- post-certification surveillance activities.
The MDR contains specific requirements for notified bodies, including the requirements set out in Annex VII and the provisions relating to their designation and surveillance.
Where to find the official list of MDR notified bodies
The official list of notified bodies designated under the MDR is available in the European Commission’s NANDO system.
NANDO is the official database of notified bodies and allows users to filter bodies by applicable legislation, including Regulation (EU) 2017/745 on medical devices.
Since the list and scope of designation of notified bodies may change over time, NANDO is the official source to consult.
What information is available in NANDO?
NANDO provides information beyond the name of the notified body.
NANDO also includes information such as:
- applicable regulation, for example MDR or IVDR;
- notified body identification number;
- country of designation;
- designation status;
- scope of designation;
- codes and technical areas covered;
- conformity assessment activities for which the body is designated.
This is important because a notified body may be designated for certain device categories, codes or activities, but not necessarily for all of them.
Why this guide does not provide a complete list
This guide does not provide a static list of MDR notified bodies.
This is intentional: the official list may be updated over time, and the most reliable information remains the one published by the European Commission in NANDO.
The fact that a body is designated under the MDR does not necessarily mean that its scope of designation covers all device categories, codes or conformity assessment activities.
For this reason, this page links to the official source and describes the main information available in NANDO.
Notified bodies, certificates and EUDAMED
Notified bodies are also connected to the management of information relating to certificates.
EUDAMED includes a module dedicated to notified bodies and certificates. This module records information relating to certificates, including issuance, changes, supplements, suspensions, reinstatements, withdrawals, refusals and restrictions, according to the applicable provisions.
In simple terms:
- NANDO allows users to consult designated notified bodies and their scope of designation;
- EUDAMED contains information relating, among other things, to notified bodies and certificates, where available and according to the functionalities made operational.
Informational note
This guide is published for informational purposes only and does not constitute regulatory, legal, technical or professional advice.
The information is based on publicly available sources and was verified as of the date of publication or the latest update of this page. It may therefore not reflect subsequent changes or developments.
For assessments relating to specific cases, reference should be made to the official texts, the latest documentation issued by the competent authorities and, where appropriate, qualified professionals.
Official sources
- Regulation (EU) 2017/745 on medical devices
- European Commission — Notified bodies for medical devices
- NANDO — New Approach Notified and Designated Organisations
- EUDAMED — Notified Bodies and Certificates module
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Related resources
- What is the MDR?
- MDR Codes
- MDR Classification Rules
- MDR Harmonised Standards
- MDR Post-Market Surveillance
- UDI and Basic UDI-DI
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© Simone Ronco. Unless otherwise stated, the editorial content of this guide is an original work.
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