What is an EU Notified Body for medical devices?

An EU Notified Body is a private conformity assessment organisation designated by an EU Member State competent authority to evaluate whether medical devices meet the requirements of EU MDR 2017/745 or EU IVDR 2017/746 before receiving CE marking. Notified Bodies have specific scopes of designation — not all can certify all device classes.

How many EU Notified Bodies are there for medical devices?

As of 2026, there are approximately 48 Notified Bodies designated under EU MDR 2017/745 and/or EU IVDR 2017/746. The full list is maintained in the European Commission's NANDO (New Approach Notified and Designated Organisations) database.

What is the difference between EU MDR and EU IVDR?

EU MDR (Medical Device Regulation 2017/745) governs medical devices and active implantable medical devices, fully applicable since May 2021. EU IVDR (In Vitro Diagnostic Regulation 2017/746) governs in vitro diagnostic medical devices. Both replaced the previous MDD and IVDD directives with stricter requirements for clinical evidence, post-market surveillance, and Notified Body oversight.

Which Notified Bodies are designated for Class III medical devices under EU MDR?

Multiple Notified Bodies hold designation for Class III implantable devices under EU MDR 2017/745, including TÜV SÜD (NB 0123), BSI Group (NB 0086), Dekra Certification (NB 0344), SGS Belgium (NB 1639), and others. The scope of designation for specific device types and MDR Annexes must be verified in NANDO for each specific device.

The Medical Device Industry Database

Your Gateway to the Medical Device Industry

Search thousands of FDA-registered companies, cleared devices, EU Notified Bodies, competent authorities, clinical guidelines, and regulatory resources.

Explore the Directory

Notified Bodies

Find 53 EU Notified Bodies designated for MDR and IVDR conformity assessment.

Browse NBs

Resources

Access 1,129 clinical guidelines, FDA guidance, MDCG documents, standards, and regulatory resources.

Browse Resources

Devices

Search 5,064 FDA-cleared medical devices with 510(k) and PMA data.

Browse Devices

Companies

Browse 4,975 FDA-registered manufacturers, distributors, and service providers.

Browse Companies

Competent Authorities

Explore 34 regulatory agencies worldwide — FDA, ANSM, BfArM, MHRA, TGA, and more.

Browse Authorities

Medical Societies

Discover 247 European and American medical societies across all specialties.

Browse Societies

EU Notified Bodies

All NBs

Latest Resources

All Docs

USPSTF Recommendation: Screening for Type 2 Diabetes

Clinical Guideline · 2021

USPSTF Recommendation: Screening for Lung Cancer

Clinical Guideline · 2021

USPSTF Recommendation: Screening for Depression in Adults

Clinical Guideline · 2016

USPSTF Recommendation: Screening for Colorectal Cancer

Clinical Guideline · 2021

Browse by Specialty

View All

Radiology

Orthopedic

General & Plastic Surgery

Cardiovascular

Dental

Gastroenterology & Urology

General Hospital

Neurology

Latest News

All News

Europe

Swissmedic Introduces New Authorisation Pathway for Herbal Medicinal Products with Orphan Drug Status

February 20, 2026

Europe

Swissmedic Introduces Machine-to-Machine Product Registration: What You Need to Know

February 20, 2026

Europe

Swissmedic Sees 17% Rise in Illegal Medicinal Product Imports from the EU in 2025

February 19, 2026

Europe

Swissmedic Initiates Batch Recall of Verkazia Augentropfen Emulsion

February 19, 2026

Medical Device Navigator

The comprehensive free database for medical device companies, FDA-cleared devices, EU Notified Bodies, competent authorities, and regulatory resources worldwide — 4,975 companies · 5,064 devices · 53 EU Notified Bodies · 1,129 regulatory documents. Founded by Dr. Hatem Rabeh (MD, MSc Ing).

Your Gateway to the Medical Device Industry