UDI and EUDAMED registration under the MDR

UDI and EUDAMED belong together. UDI (Unique Device Identification) is the unique code on your medical device and its packaging. EUDAMED is the European database where you register yourself, your devices and your certificates. Since 28 May 2026, use of the first four EUDAMED modules has been mandatory, according to the European Commission .

Both obligations come from the EU MDR 2017/745 , not from ISO 13485. The standard does require traceability, however, and you need that to manage UDI properly. For how the law and the standard relate to each other, read MDR and ISO 13485. In the Netherlands, you arrange your registration as a market participant via Farmatec of the CIBG (the Dutch Health Care Agency).

UDI and EUDAMED apply to every MDR risk class, including class I. Only custom-made devices are exempt from the UDI requirement.

What is UDI and what are its parts?

UDI is a code that lets you trace every device through the supply chain, from factory to patient. The code consists of fixed and variable parts.

Component	What it identifies	Where it appears
Basic UDI-DI	The product family with the same intended use, risk class and design	In EUDAMED, your declaration of conformity and certificates, not on the label
UDI-DI	The specific model or packaging variant	On the label and packaging
UDI-PI	The production unit: lot, serial number, expiry date or production date	On the label and packaging
UDI carrier	The display: a barcode or data matrix plus human-readable text	On the label, packaging and sometimes on the product itself

You do not get UDI codes from the government. You obtain them from an accredited issuing entity. The European Commission has designated four: GS1, HIBCC, ICCBBA and IFA. In the Netherlands, most manufacturers choose GS1.

Example of a UDI code

A manufacturer of surgical scissors uses GS1. The label shows this human-readable text below the data matrix (fictional):


(01)08712345000013(17)271231(10)LOT2026A(21)SN0042

Part	Meaning	Type
(01) 08712345000013	Product code for this model	UDI-DI
(17) 271231	Expiry date 31 December 2027	UDI-PI
(10) LOT2026A	Lot number	UDI-PI
(21) SN0042	Serial number	UDI-PI

If a recall is needed, the hospital can use this code to see exactly which scissors from which lot must be returned.

When must the UDI be on the label?

The MDR introduced the UDI carrier in stages. All of these deadlines have passed. Products you place on the market now must therefore carry the UDI.

Class	UDI on label mandatory since	Directly on reusable product since
Class III and implantables	26 May 2021	26 May 2023
Class IIa and IIb	26 May 2023	26 May 2025
Class I	26 May 2025	26 May 2027

Note the last row: reusable class I products, such as surgical instruments that are sterilised, must carry the UDI on the product itself from 26 May 2027.

Which EUDAMED modules are mandatory?

EUDAMED has six modules. With Decision (EU) 2025/2371, the Commission declared the first four functional. After a transition period of six months, they have been mandatory since 28 May 2026.

Module	What you register	Status
Registration of economic operators	Your organisation, which receives an SRN (single registration number)	Mandatory since 28 May 2026
UDI and devices	Basic UDI-DI, UDI-DI and product data	Mandatory since 28 May 2026
Notified bodies and certificates	Your certificates, entered by the notified body	Mandatory since 28 May 2026
Market surveillance	Activities of supervisory authorities	Mandatory since 28 May 2026
Vigilance and post-market surveillance	Incidents, safety actions and reports	Still in development
Clinical investigations and performance studies	Applications and results of studies	Still under analysis

The Commission states that the last two modules become mandatory as soon as they are ready, with no voluntary period. Check the current status on the Commission’s EUDAMED page .

Which EUDAMED deadlines are still running?

For products that were already on the market before 28 May 2026, catch-up deadlines apply.

What	Deadline
New device that you first place on the market from 28 May 2026	Register before you place it on the market
Devices already on the market that stay there, including legacy products under the old directive	Register by 28 November 2026 at the latest
Certificates issued before 28 May 2026	The notified body enters them by 28 May 2027 at the latest
Changes to a notification that is not yet in EUDAMED	Via the Dutch system NOTIS up to and including 27 November 2026

According to Farmatec, products that have been notified in the Netherlands via NOTIS for years must still be registered in EUDAMED. An old Dutch notification does not replace this.

Step by step: arranging UDI and EUDAMED

For a manufacturer in the Netherlands, the order looks like this.

Apply for an SRN

Create an EU Login account, select the competent authority NL-CA-058 in EUDAMED and enter your Chamber of Commerce (KvK) number. The CIBG checks the application and assigns your SRN. According to Farmatec, the processing time is 15 days.

Choose an issuing entity

Join GS1, HIBCC, ICCBBA or IFA and create your Basic UDI-DIs and UDI-DIs.

Collect product data

For each UDI-DI, you need, among other things, the MDR risk class, the intended use, the packaging levels and any sterilisation. This data is already in your technical documentation.

Register in EUDAMED

Enter the data manually, upload a file or connect your system. For many products, a connection is worthwhile.

Adjust the labels

Put the UDI carrier on the label and packaging, and on the product itself for reusable products.

Secure the management

Record in your quality system who changes UDI data and when EUDAMED is updated. A change to your product may require a new UDI-DI.

Common mistakes with UDI and EUDAMED

Confusing Basic UDI-DI and UDI-DI. The Basic UDI-DI is the family and does not appear on the label.
Forgetting legacy products. Products under the old directive must also be in EUDAMED.
Not naming an owner. Product data goes out of date quickly. Without a fixed owner, EUDAMED will be wrong within a year.
Managing UDI separately from the quality system. Link UDI to your change control and CAPA process, or you will fall behind during a recall.