EU EUDAMED Medical Device & IVD Registration

EUDAMED is an electronic database designed to improve transparency, accessibility, and traceability of medical devices and IVDs in the EU market.

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EU Market information

What is EUDAMED?

The Medical Devices Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostics Regulation (EU) 2017/746 (IVDR) introduced the requirement for a comprehensive electronic database known as the European Database for Medical Devices (EUDAMED). This platform developed by the European Commission is designed to improve transparency, accessibility, and traceability of medical devices and IVDs in the EU market. The EUDAMED system will be used by Economic Operators, Notified Bodies, Member State authorities, healthcare professionals, and even the public to access critical device information.

EUDAMED is structured into six core modules:

Actor Registration
Unique Device Identification (UDI) and Device Registration
Notified Bodies and Certificates
Clinical Investigations and Performance Studies
Vigilance and Post-Market Surveillance
Market Surveillance

When is EUDAMED registration required?

Implementing Decision (EU) 2025/2371 confirmed the functionality of the first four EUDAMED modules (Actor Registration, UDI & Device Registration, Notified Bodies & Certificates, and Market Surveillance), kicking off a six-month transition period. Mandatory use will be required from 28 May 2026.

Important EUDAMED registration dates:

27 November 2025: Official confirmation of functionality; six month transition begins.
28 May 2026: Mandatory use of the first four EUDAMED modules.
28 November 2026: Deadline for registering "legacy" devices already on the market.
Q2 2027: Anticipated mandatory use of the Vigilance module.

How to register your company in EUDAMED

Manufacturers (EU and non-EU), along with System/Procedure Pack Producers (SPPP), Authorized Representatives (AR), and Importers are required to register as an Actor in EUDAMED. To register using the Actor module, you must create an EU login account in EUDAMED and provide basic information about your company, such as address and contact information. You must also name key regulatory personnel, including your AR if you are not based in the EU. This includes naming your Person Responsible for Regulatory Compliance (PRRC).

On submission, your Actor registration will route to your AR or your Competent Authority for review and approval, based on your location in the respective EU Member state. Once approved, you will receive a Single Registration Number (SRN), and your company will be published in the EUDAMED Public Database.

How to register your device in EUDAMED

All medical devices and IVDs that are CE Marked must be registered in EUDAMED, including self-certifying devices (class I medical devices, class A IVDs or legacy devices). To register a device or IVD using the UDI/Devices module, you will need to supply detailed information about your device, including:

UDI (Basic UDI, UDI-DI, and UDI-PI)
Name of UDI-issuing body
Device Reference / Catalogue number
European Medical Device Nomenclature (EMDN) Code
Device trade name or model name
Device classification
Device description and characteristics (single use, sterility, storage conditions, warnings)
Device information for presence of human or animal tissues and cells or their derivatives
All EU Member States where the device is made available

Device information in the UDI module is publicly accessible. Changes to key device information or characteristics can require a new UDI and updated registration in EUDAMED.

more EU services

MDR Consulting

IVDR Consulting

EU Authorized Representative

CE Mark Notified Body Search & Selection

Person Responsible for Regulatory Compliance (PRRC)

MDR & IVDR Post-Market Surveillance (PMS)

Documents and links

EUDAMED Database

Actor Module User Guide

UDI Devices Module User Guide

How We Can Help

EUDAMED support & EU Representation for a Simple Annual Fee

From our offices in the EU, we can act as your EU Authorized Representative and deliver essential regulatory support for a flat annual fee. We cover representation, EUDAMED support, document review, CFS processing, and more, starting at $2,000/year. No hourly billing or unexpected invoices.

Frequently
Asked Questions

What are the mandatory use deadlines for EUDAMED?

The mandatory use deadline for the first four EUDAMED modules (Actors, UDI/Devices, Notified Bodies, Market Surveillance) is 28 May 2026, following a six-month transition period.

The deadline for registering legacy devices in EUDAMED is 28 November 2026.

Mandatory use of the Vigilance module is expected in Q2 2027.

What is basic UDI for medical devices in the EU?

Basic UDI identifies a group of devices that share the same intended purpose, classification, design, and characteristics. In EUDAMED, Basic UDI is the key that references information about that group of devices, but it does not appear on the device labeling.

UDI is the numeric or alphanumeric code that appears on the device label to identify that specific device on the market. UDI includes the UDI device identifier (UDI-DI), which is specific to a device, and a UDI production identifier (UDI-PI) that identifies the device unit.

How do we obtain UDI for our device?

UDI-DI is a code of numeric or alphanumeric characters that is unique to a device. UDI codes must be purchased from an issuing agency, which can take several days. You will need to provide the device’s UDI and the name of the UDI issuing agency to complete your EUDAMED device registration.

Single Process,
Multiple Markets

When you partner with Pure Global, a single registration process opens doors to multiple countries. Our global subsidiaries make this streamlined path possible.