Complete List of Notified Bodies Under the MDR

Medical devices of classes IIa, IIb and III, and class I devices that are sterile, have a measuring function or are reusable surgical instruments, need a notified body designated under Regulation (EU) 2017/745 before they can be placed on the EU market. Other class I devices do not (MDR Article 52(7)). Custom-made devices, investigational devices and systems and procedure packs follow their own rules (Articles 52(8), 62 to 81 and 22). This page lists all notified bodies designated under the MDR, from the EU's own database.

What is a notified body?

The MDR defines a notified body as "a conformity assessment body designated in accordance with this Regulation" (Article 2(42)). Notified bodies are designated, not certified. A designation becomes valid the day after the notification is published in NANDO, the database of notified bodies developed and managed by the European Commission (Article 42). Notifications issued under the former directives became void from 26 May 2021 (Article 120(1)), so a body needs a designation under the MDR to work under it.

The notified body takes part in the conformity assessment for the device's risk class (Article 52). Which class applies is set out in our guide on classifying medical devices.

All Notified Bodies Designated Under the MDR

As of 9 November 2026, NANDO lists 51 notified bodies under the MDR. Source: NANDO, Single Market Compliance Space.

"First notified in NANDO" is the approval date of the first version of the body's MDR notification in NANDO. Names are shown as NANDO records them. The list includes bodies established in Norway and Türkiye, which NANDO also lists under the MDR.

A designation covers specific device types and conformity assessment procedures, and it can end, be restricted or be suspended. Before you approach a notified body, check its entry in NANDO.

Deadlines for Legacy Devices

Regulation (EU) 2023/607 extended the transition period for devices with a valid certificate or declaration under the former directives (MDR Article 120):

These dates apply only under the conditions of Article 120(3c). Among them: no significant changes in design and intended purpose, a quality management system in place by 26 May 2024, a formal application lodged with a notified body by 26 May 2024, and a written agreement signed by 26 September 2024.

The Commission's December 2025 proposal to simplify the MDR and IVDR (procedure 2025/0404(COD)) had not been adopted by the date above.

Sources

• NANDO: notified bodies under Regulation (EU) 2017/745
• Regulation (EU) 2017/745 (MDR), consolidated version of 9 November 2026
• Regulation (EU) 2023/607

See also the list of notified bodies under the IVDR.

General information, not legal advice. Legal status as of 9 November 2026.

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