For years EUDAMED, the European database on medical devices, was voluntary. That changed on 28 May 2026. Since then the actor registration and the UDI and device registration modules are mandatory under the Medical Device Regulation (MDR). A Class I device that is not registered may not be placed on the EU market.
Class I is the lowest risk class, and most manufacturers can declare conformity themselves without a notified body. That makes Class I look simple. In practice the registration trips up many sellers, because it involves new identifiers, an authorised representative in the EU and a label that has to match what is in the database.
- What EUDAMED is and which deadlines apply
- First check: is your product a Class I medical device?
- Step 1: an authorised representative and your SRN
- Step 2: Basic UDI-DI, UDI-DI and UDI-PI
- Step 3: register your device in EUDAMED
- The UDI and other labelling requirements
- Checklist for EUDAMED registration of a Class I device
What EUDAMED is and which deadlines apply
EUDAMED is the database the European Commission set up under the MDR. It links manufacturers, authorised representatives, importers, devices and certificates, and gives market surveillance authorities one place to check them. The Commission confirmed on 27 November 2025, in Decision (EU) 2025/2371, that four modules work: actor registration, UDI and device registration, notified bodies and certificates, and market surveillance. Under Regulation (EU) 2024/1860 their use became mandatory six months later.
| Date | What applies |
|---|---|
| 26 May 2025 | Class I devices must carry a UDI on the label and on every higher level of packaging |
| 28 May 2026 | Actor registration and device registration in EUDAMED are mandatory. A new device must be registered before the first unit is placed on the market |
| End of November 2026 | Devices placed on the market before 28 May 2026 and still sold afterwards must be registered within twelve months of the notice of 27 November 2025 |
| 26 May 2027 | Reusable Class I devices must also carry the UDI directly on the device itself |
Do you already sell a Class I device in the EU that you have not registered? Then the deadline at the end of November 2026 is the one to act on now.
First check: is your product a Class I medical device?
Before you register anything, make sure the MDR applies and that your device is really Class I. Whether a product is a medical device depends on its intended purpose: what you say it does on the label, in the instructions and in your marketing (Article 2 of the MDR). A wrist support sold for comfort is a consumer product. The same support sold to treat an injury is a medical device.
The risk class follows from the 22 classification rules in Annex VIII of the MDR. Many simple products end up in Class I through Rule 1, which covers non-invasive devices unless another rule applies. The Commission explains how to apply the rules in guidance document MDCG 2021-24.
We see it often: manufacturers do everything they can to argue that their product is not a Class I medical device, because the MDR brings extra work. That is a legal assessment, not a choice. Test your product and your claims against the definition in Article 2 and the rules in Annex VIII, and keep that reasoning in your technical documentation. If an authority classifies your product differently, your listings can be taken offline.
Also check whether you fall into one of the special Class I groups: sterile devices (Is), devices with a measuring function (Im) and reusable surgical instruments (Ir). For those aspects you need a notified body. Our EU Authorised Representative service for Class I medical devices covers standard Class I devices only.
Step 1: an authorised representative and your SRN
Every manufacturer registers as an actor in EUDAMED and receives a Single Registration Number (SRN). As a manufacturer outside the EU you cannot do that on your own. You need an authorised representative in the EU that is already registered in EUDAMED with its own SRN. Our article on EU REP and EC REP explains how this role differs from the EU REP for consumer products.
The registration goes in this order:
- Sign a written mandate with your authorised representative.
- Create an EU Login account and start an actor registration request in EUDAMED as a non-EU manufacturer.
- Select your authorised representative by its SRN, enter the start and end date of the mandate and upload the mandate summary document. All actors also upload a signed declaration on information security responsibilities.
- Your authorised representative verifies your request in EUDAMED.
- The competent authority of the country where your representative is established validates it and issues your SRN.
Only with an SRN can you register devices. Use the SRN in your regulatory documents from then on.
Step 2: Basic UDI-DI, UDI-DI and UDI-PI
The MDR uses three identifiers. They are easy to mix up, and a mistake here repeats itself in the database, on your declaration of conformity and on your label.
| Identifier | What it identifies | Where you use it |
|---|---|---|
| Basic UDI-DI | A device model or group: same intended purpose, risk class and essential design and manufacturing characteristics | The main key in EUDAMED, on your declaration of conformity and in your technical documentation. Not on the label |
| UDI-DI | One specific version and packaging level of the device, for example a box of 10 or a box of 50 | In the barcode on the label and in EUDAMED |
| UDI-PI | The production unit: lot or batch number, serial number, expiry or manufacturing date | In the barcode on the label, it changes per batch. Not in EUDAMED |
You do not make up these numbers yourself. They must follow the system of an issuing entity designated by the Commission. There are four: GS1, HIBCC, ICCBBA and IFA. Most manufacturers of Class I products choose GS1. You become a member of your local GS1 organisation, receive a company prefix and use a GTIN as your UDI-DI. GS1 also has a format for the Basic UDI-DI.
Step 3: register your device in EUDAMED
With your SRN and identifiers ready, you register the device in the UDI and device module. Under Article 29 of the MDR you do that before you place the device on the market. You enter the Basic UDI-DI with its core data, such as risk class, intended purpose and device description, and the UDI-DIs that belong to it.
Through your mandate the device record is linked to your authorised representative. Keep the data current. If you change the design, intended purpose or packaging, that can mean a new UDI-DI or even a new Basic UDI-DI.
Need an authorised representative for your Class I device? We act as your EU Authorised Representative for Class I medical devices and verify your link in EUDAMED.
The UDI and other labelling requirements
Since 26 May 2025 every Class I device must carry the UDI carrier on its label and on all higher levels of packaging. The carrier has two forms: a barcode that machines read, such as a GS1 DataMatrix or GS1-128, and the same data in human readable text. The barcode contains the UDI-DI and, where relevant, the UDI-PI.
The UDI is only part of the label. Section 23 of Annex I of the MDR sets out the rest. For a Class I device from outside the EU, check at least these points:
- the name or trade name of the device and the information a user needs to identify it
- the name and address of the manufacturer
- the name and address of the authorised representative in the EU
- an indication that the product is a medical device, usually the MD symbol
- the lot number or serial number, and an expiry or manufacturing date where it applies
- the CE marking
- storage conditions, warnings and precautions where they apply
Labelling mistakes are the most common reason a Class I device is not ready for the market. The Basic UDI-DI on the declaration, the UDI-DI in the barcode and the record in EUDAMED must match. Our blog on the Medical Device Regulation for importers explains the other obligations around the label.
Checklist for EUDAMED registration of a Class I device
- Confirm that your product is a medical device and Class I, with your reasoning in the technical documentation.
- Check whether your device is sterile, measures or is a reusable surgical instrument. Then you need a notified body.
- Sign a mandate with an authorised representative that has an SRN.
- Register as an actor in EUDAMED and wait for your SRN.
- Get your identifiers from an issuing entity, usually GS1: a Basic UDI-DI per device group and a UDI-DI per version and packaging level.
- Put the Basic UDI-DI on your declaration of conformity and in your technical documentation.
- Register the device in EUDAMED before the first unit is placed on the market.
- Put the UDI carrier, the authorised representative, the MD symbol and the CE marking on the label and packaging.
- Already on the market before 28 May 2026? Register by the end of November 2026.
EUDAMED registration is mostly careful administration, but it only works if the classification is right. Start there, and the database, the declaration and the label will follow from it.
Sources
- Regulation (EU) 2017/745 on medical devices (MDR), Articles 2, 27, 29, 31 and 123, Annex I section 23, Annex VI and Annex VIII
- Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed
- Commission Decision (EU) 2025/2371 on the functionality of four EUDAMED modules, published in the Official Journal on 27 November 2025
- Commission Implementing Decision (EU) 2019/939 designating the UDI issuing entities, renewed by Implementing Decision (EU) 2024/2120
- European Commission, EUDAMED user guide for economic operators and the actor registration help pages
- European Commission, UDI Helpdesk, deadlines for the UDI carrier
- MDCG 2021-24, Guidance on classification of medical devices
