Updated July 2026
IVDR notified bodies are conformity assessment bodies designated to perform specific activities under Regulation (EU) 2017/746 on in vitro diagnostic medical devices.
They play a central role in the CE marking pathway for many in vitro diagnostic medical devices, particularly when the applicable conformity assessment procedure requires the involvement of an independent third party.
This guide explains, for informational purposes, what IVDR notified bodies are, when they may be involved, and where to find the updated official list.
In this guide
- What are IVDR notified bodies?
- When may an IVDR notified body be involved?
- What does a notified body assess?
- Where to find the official list of IVDR notified bodies
- What information is available in NANDO?
- Why this guide does not provide a complete list
- Notified bodies, certificates and EUDAMED
What are IVDR 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 in vitro diagnostic 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 IVDR, the notified body assesses whether the manufacturer and the device meet the applicable requirements within the relevant conformity assessment procedure.
When may an IVDR 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 IVDR provides that in vitro diagnostic medical devices are classified into four classes: A, B, C and D. 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.
Devices belonging to higher risk classes generally require a greater level of notified body involvement. Under the IVDR, class B, C and D devices require the involvement of a notified body in the conformity assessment procedure.
Class A devices that are not placed on the market in sterile condition normally do not require the involvement of a notified body, while for class A devices placed on the market in sterile condition the involvement of the notified body is limited to the aspects relating to sterility.
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;
- evidence relating to performance evaluation;
- scientific validity, analytical performance and clinical performance, where relevant;
- general safety and performance requirements;
- post-certification surveillance activities.
The IVDR 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 IVDR notified bodies
The official list of notified bodies designated under the IVDR 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) 2017/746 on in vitro diagnostic 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 IVDR 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 IVDR 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) 2017/746 on in vitro diagnostic 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 IVDR?
- IVDR Codes
- IVDR Classification Rules
- IVDR Harmonised Standards
- IVDR 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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