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.

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