If you manufacture a medical device or an IVD that was already on the market before 28 May 2026 and you are still placing units on the market, you must register it in EUDAMED by 28 November at the latest, subject to the exceptions set out in this guide. If you import it, you must check that it is registered.
Here you will find which devices fall within the deadline, the order in which to complete each procedure and how it connects with RECOPS, the Spanish national register run by the AEMPS.
Quick answer
- Deadline: 28 November 2026, according to the European Commission. It is a Saturday, so treat Friday 27 November as the last working day.
- Which devices are covered: legacy devices and MDR or IVDR devices that were already on the market before 28 May 2026, if units are still being placed on the market.
- Where to start: check today that your company is registered in EUDAMED. Without that you cannot register devices, and that registration has no extra time: it has been mandatory since 28 May 2026.
What falls due in November
Decision (EU) 2025/2371 was published in the Official Journal of the EU on 27 November 2025 and triggered this timetable:
| Date | What happens |
|---|---|
| 28 May 2026 | Four EUDAMED modules become mandatory: actors, UDI and devices, notified bodies and certificates, and market surveillance. A new Regulation device must be registered before its first unit is placed on the market. |
| 15 June 2026 | RECOPS comes into operation in Spain and replaces CCPS and RPS for new communications. |
| 28 November 2026 | Deadline to register devices that were already on the market before 28 May 2026. |
| 28 May 2027 | Deadline, according to the Commission, for notified bodies to register MDR and IVDR certificates issued before 28 May 2026. |
Why you will see other dates. The MDR gives 12 months from publication of the notice in the Official Journal, which is why some pages calculate 27 November. The IVDR gives six months from 28 May 2026. The Commission publishes 28 November 2026 in its official EUDAMED material. The difference is minimal, but it is one more reason not to leave it to the last minute.
It is not only legacy devices
Many pages only mention legacy devices, but the deadline also covers MDR and IVDR devices that were already on the market before 28 May 2026 and have not yet been registered. Review your whole portfolio, not only what is still under a Directive.
A legacy device is one that continues to be placed on the market under the transitional provisions of the MDR or the IVDR. It may have a Directive certificate. It may also have none, if it has a declaration of conformity under the Directive drawn up before 26 May 2021 (26 May 2022 for IVDs), requires a notified body under the Regulation and meets the transitional conditions.
A device that does not need a certificate under the Regulation, such as an MDR class I device without a notified body, cannot be a legacy device. It is registered as a Regulation device.
Do I have to register this device?
Check reference by reference. EUDAMED registers at UDI-DI or EUDAMED ID level, not at commercial family level.
| Device situation | What to do | When |
|---|---|---|
| Regulation device whose first unit with that UDI-DI is placed on the market from 28 May 2026 | Register it as a Regulation device | Before placing the first unit on the market |
| MDR or IVDR device, already on the market before 28 May 2026, with units still being placed on the market | Register it as a Regulation device | By 28 November 2026 at the latest |
| Legacy device with units still being placed on the market | Register it as a legacy device, unless “the same device” is already registered as a Regulation device | By 28 November 2026 at the latest |
| Legacy device with “the same device” already registered as a Regulation device | No need to register it | Only if a vigilance action concerns the legacy device and not the Regulation device |
| No units placed on the market from 28 May 2026 | No need to register it | Only if a vigilance or post-market surveillance action has to be carried out in EUDAMED |
| System or procedure pack | Registered by its producer, following the same date logic | Depending on whether it is placed on the market before or after 28 May 2026 |
| Investigational device or device for performance studies | Not registered in the devices module | Not applicable |
| Custom-made device | Cannot be registered in the devices module | In the event of a serious incident or field safety corrective action, a limited set of data is provided |
| “Old” device (as described in MDCG 2021-25 and MDCG 2022-8) | Cannot be registered in the devices module | In the event of a serious incident or field safety corrective action, a limited set of data is provided |
“The same device” means that the legacy device and the Regulation device share their identification: UDI-DI, catalogue or reference number, or a trade name derived from shared characteristics. If the move to the Regulation would lead to a new UDI-DI, it is no longer the same device.
There is a nuance in Spain: if you still market the Directive version and it is not registered as a legacy device, you will not be able to communicate it in RECOPS.
Vigilance. This module is not yet mandatory, and incidents are still reported through the national route. Once it is, an unregistered device will have to be registered before the report can be submitted in EUDAMED.
Step 1: register the company and obtain the SRN
Nothing else can happen without this step: actor registration is what allows you to register devices and work in EUDAMED. It is not subject to the November deadline, because it has been mandatory since 28 May 2026. If you are already placing devices on the market without it, regularise this immediately.
Who needs to register. Manufacturers, importers, authorised representatives and system and procedure pack producers. Distributors do not register in EUDAMED, although they may have national obligations. You also do not need to register if you no longer place devices on the market from 28 May 2026, unless a manufacturer or its authorised representative has to carry out a vigilance or post-market surveillance action.
How to apply.
- Create an EU Login account.
- Go to the EUDAMED restricted area and create an actor registration request.
- The AEMPS reviews the request if your company is based in Spain.
- Once approved, EUDAMED generates the identifier and notifies you by email.
The SRN format is country, role and nine digits (ES-MF-XXXXXXXXX). Each role needs its own request: a company that both manufactures and imports will have two. System and procedure pack producers, and those who only market legacy or custom-made devices, receive an Actor ID with the same structure instead of an SRN.
Information to have ready. Name and address of the organisation, identifiers (VAT, EORI or trade register, if applicable), public contact details and contact details for the authorities, the person responsible for regulatory compliance (manufacturers and authorised representatives) and, where applicable, subcontractor details. You must also upload a signed declaration on information security responsibilities.
Who enters the data. The person who submits the request becomes the first administrator (LAA). The Commission advises having two, because users cannot approve changes to their own profile. Anyone who is going to act on behalf of your company must request access, and that request is validated by your LAA or LUA. In our understanding, this is also how a consultancy can help you. Responsibility remains with the manufacturer, and neither the authorised representative nor the importer can register devices in its place.
Check the profile. In the devices module the default profile is Viewer, which only allows viewing. Proposer is needed to create drafts and Confirmer to submit them.
Non-EU manufacturers. They need an active authorised representative that is already registered, and must submit a mandate summary document. The representative verifies the request before it goes to the competent authority of its country.
SRN and prior licence are separate procedures. The AEMPS says so expressly: registration in EUDAMED is independent of the prior operating licence. Having one does not give you the other.
Step 2: register the devices
Which identifier you need
| Identifier | For which device | What it is |
|---|---|---|
| Basic UDI-DI | MDR and IVDR | Groups devices with the same intended purpose, risk class and essential design and manufacturing characteristics. |
| UDI-DI | MDR and IVDR, and legacy devices that already have one | Identifies a specific model, variant or version. It is assigned by the manufacturer through an issuing entity such as GS1, HIBCC, ICCBBA or IFA. |
| EUDAMED DI | Legacy | Equivalent to the Basic UDI-DI. It starts with B-. |
| EUDAMED ID | Legacy without a UDI-DI | Equivalent to the UDI-DI, but virtual: it is not printed on the label. It starts with D- and is generated by EUDAMED. |
Regulation devices
The module asks for, in this order: the applicable legislation, the Basic UDI-DI and its attributes, certificate details where applicable, the UDI-DI with its nomenclature code (EMDN) and characteristics and, where applicable, the packaging.
Legacy devices
- If it already has a UDI-DI, use it: EUDAMED generates the EUDAMED DI by adding
B-in front. - If it does not, assign a EUDAMED DI in the format set by the Commission, and EUDAMED will generate the EUDAMED ID.
Each EUDAMED DI corresponds to a single device, unlike the Basic UDI-DI, which can group several. Plan one registration per reference. The Directive certificate details (notified body, identification and expiry) are entered by the manufacturer.
When the device moves to the Regulation, you can link it to its legacy version: EUDAMED does this automatically if they share a UDI-DI and, if not, you can do it manually.
How to upload the data
- Manual: the most direct option with few references.
- XML bulk upload: for larger volumes, from Data transfer > Bulk Upload. The response shows the result for each device: resubmit only those that returned an error.
- Machine to machine (M2M): requires an access point approved by the Commission, technical set-up and connectivity tests, first in the test environment. With so little time left, this is not the way to meet this deadline.
When it becomes visible
A device is only public when it is in the Registered state. Some high-risk devices, covered by type-examination or technical documentation certificates, remain in Submitted until the notified body confirms them when registering its certificate.
In that case you have already met your registration obligation, but the device will not be visible until then. And notified bodies have until 28 May 2027 for certificates already issued. It is worth coordinating with yours, because the next step depends on that visibility.
Step 3: communicate it in RECOPS
EUDAMED and RECOPS do not replace each other. The AEMPS requires the device to be notified and visible in EUDAMED before it can be communicated in RECOPS, which takes the device, manufacturer and certificate data from EUDAMED.
Deadlines, according to the AEMPS FAQ (updated on 2 October 2026):
- Notified in EUDAMED before 28 May 2026: a maximum of six months from that date, which also means November.
- Notified from 28 May 2026: before you start marketing it in Spain. If you were already marketing it before 15 June 2026, as soon as possible once it is notified and visible. A device you register now does not have six months.
- Not yet visible in EUDAMED: the AEMPS accepts that it may continue to be marketed while the communication cannot be made for this reason, and asks for it to be made as soon as the device is visible. This only affects RECOPS: it does not suspend the EUDAMED deadline.
Other points that often go unnoticed:
- Communications in CCPS and RPS do not transfer automatically: they must be made again. If you state the previous number, you may be exempt from the initial fee.
- Each operator marketing in Spain makes its own communication, even if another has already done so. What counts is its functions, not whether it calls itself a distributor or wholesaler. The AEMPS provides for exceptions, such as entities in the same corporate group.
- You must communicate the device you actually market. If you sell the Directive version and it is not visible in EUDAMED as such, you will not be able to communicate it.
- Each communication has an initial fee of €99.71 and an annual maintenance fee of €59.83, with tiered reductions. You must also attach the labelling and instructions for use with which you market the device in Spain.
More detail in our news item on RECOPS.
If you are an importer
Your registration does not replace the manufacturer’s, but it does oblige you to check it. If you import medical devices, you need to:
- Have your own importer SRN (IM role), before placing devices on the market.
- Check that the device is registered (Article 13(4) MDR and IVDR). If you consider that the device is not in conformity, you must not place it on the market until it has been brought into conformity (Article 13(2)).
- Check the actor data of the manufacturer or its authorised representative within two weeks of placing the device on the market, and inform them if data is missing or incorrect (Article 30(3) MDR and Article 27(3) IVDR).
- Add your details to the relevant entries. In EUDAMED, the Linker profile lets you link your company to non-EU manufacturers.
- Make your communication in RECOPS, if this applies to you according to your functions.
You can make a first check of the manufacturer and its devices with our EUDAMED search tool, which queries public data. Search by the exact name or by the identifier. If a device does not appear, also check the official portal before drawing conclusions, and ask the manufacturer whether it is in the Submitted state.
Plan up to 27 November
| When | What to do |
|---|---|
| By 8 November | Check the SRN and, if missing, apply for it. Review LAA and profiles. Make the inventory of references and apply the decision table. Tell the notified body what depends on it. |
| 9 to 15 November | Gather the data for each reference. Obtain any missing UDI-DIs or assign the EUDAMED DIs. Decide between manual upload and XML. Register a small first batch to detect errors. |
| 16 to 22 November | Register the rest. Correct rejections. Check which devices already appear as Registered. Communicate in RECOPS those that are visible. |
| 23 to 27 November | Review the complete list against the inventory. Close RECOPS. Document whatever remains pending from third parties, such as notified body confirmation. |
If you do not yet have an SRN, start there today: its timing does not depend on you.
Mistakes to avoid
- Assuming the notified body or authorised representative will do it. The notified body registers certificates, not your devices. Responsibility lies with the manufacturer.
- Looking only at legacy devices and forgetting MDR and IVDR devices that were already on the market before 28 May 2026.
- Treating a class I device without a notified body as legacy. It is registered as a Regulation device.
- Registering by family. For legacy devices, each EUDAMED DI is a single device.
- Assuming CCPS and RPS transfer to RECOPS. You must communicate again.
- Resubmitting the whole XML after a partial error. The correct devices have already been created: resubmit only those that failed.
- Counting on six months for RECOPS for a device you are registering now.
What happens if you miss the deadline
We have not found any official announcement of an extension. After the deadline, continuing to place units of an unregistered device on the market breaches the manufacturer’s obligation, with these practical consequences:
- The importer must check that registration before placing the device on the market.
- Without visibility in EUDAMED, the communication in RECOPS cannot be completed.
- The situation is exposed to market surveillance by the competent authorities.
If you are not going to get through your whole portfolio, start with your best-selling references and document the reason for whatever remains pending. This does not remove the breach, but it lets you explain the situation and close it as soon as possible.
Frequently asked questions
Do I have to register a legacy device without a notified body certificate?
Yes, if it is a legacy device and you are still placing units on the market. This is the case of a device with a declaration of conformity under the Directive that requires a notified body under the Regulation.
If I have already registered the MDR version, do I also have to register the legacy one?
No, if it is “the same device”. The exception is a vigilance action that concerns the legacy device and not the Regulation device: the legacy device must then be registered so that it can be reported. If you still sell the Directive version in Spain, also bear in mind the RECOPS nuance.
Can a consultancy enter the data for me?
In our understanding, yes. The Commission states that anyone who is going to act on behalf of an actor must request access, and the MDCG accepts that the practical operation of UDI can be delegated to a third party. The consultancy works with its own user account and with access approved by your LAA or LUA. Responsibility remains with you as the manufacturer.
How long does the AEMPS take to validate the SRN?
We have not found a published timeframe. In the two cases we have handled at MeDev Consulting, validation came in less than a week. This is a small sample and does not guarantee the same timing in your case, so submit a complete request as soon as you can.
Can I test before registering?
EUDAMED has a test environment, Playground, with fictitious data. Real registrations are made in the production environment.
Do I have obligations after registering?
Yes. You must update your company data within one week of any change and confirm that it is correct no later than one year after submitting it and, from then on, every two years.
How MeDev Consulting can help
We review your portfolio reference by reference, handle the SRN application, prepare and upload the device data, and make the RECOPS communications. We also help importers check their manufacturers.
If you have devices on the market and have not started yet, tell us about your case and we will see what can be closed before 28 November. More information on our licences and registrations service.
Official sources
Last reviewed: 4 November 2026.
- Commission Decision (EU) 2025/2371
- Regulation (EU) 2024/1860, amending Article 123(3) MDR and Article 113(3) IVDR
- Questions and answers on the gradual roll-out of EUDAMED (November 2024)
- European Commission: getting ready for the mandatory use of EUDAMED, with the presentation stating 28 November 2026
- European Commission: actor registration and UDI and device registration
- AEMPS: which operators and devices must be registered
- AEMPS: frequently asked questions on RECOPS
This guide is for information only and does not replace the analysis of each device.