EUDAMED is now mandatory. Here’s how to plan early and submit smoothly

As of 28 May 2026, EUDAMED is required if you're looking to bring a medical device to market. Here, we explain how to complete the process with minimal friction.

In November 2025, the Commission Decision (EU) 2025/2371 confirmed four modules as fully functional and legally required, triggering mandatory use of EUDAMED (The European Database on Medical Devices) from 28 May 2026.

The four mandatory modules are:

• Actor Registration

• UDI / Device Registration

• Notified Bodies & Certificates

• Market Surveillance

The requirement affects your actor registration, your devices, your certificates, and what we expect before accepting a conformity assessment application. 

It’s important to note that these modules are a legal requirement, and placing devices on the EU market without them is a regulatory violation that may significantly delay certification and block market access. 

It’s an extra step, but in effect, the goal of the legislation is to create transparency, strengthen market surveillance, and replace the disparate reporting and information systems of EU member states with a single database. 

Here are the steps required (and what we recommend) to prepare ahead of submission.

Step 1: Appoint an EU Authorised Representative (for non-EU manufacturers)

Non-EU manufacturers cannot obtain an SRN, or place devices on the EU market without a formally appointed EU Authorised Representative (AR). Your SRN is issued by the Competent Authority of the Member State where your AR is established. 

Critically, device registration in EUDAMED cannot be delegated to your AR. Under MDR Article 11 (4), you (the manufacturer) are responsible for UDI and device data entry. Your AR verifies compliance, but they do not perform it on your behalf.

Step 2: Get your SRN (Actor Registration)

The Single Registration Number (SRN) is the prerequisite for everything else in EUDAMED. Without it, no device data can be submitted and no certificate can be linked to your organisation. All manufacturers, EU Authorised Representatives, and importers must register in the Actor module. Once validated by the relevant Competent Authority, EUDAMED generates your SRN. If you are a non-EU manufacturer, the AR will verify the actor registration prior to the national Competent Authority assessment.

Your SRN must appear on your:

•  EU Declaration of Conformity

• All conformity assessment applications submitted to us

• PSURs, FSCAs, and serious incident reports

Step 3: Submit your application for conformity assessment

With your SRN issued, and your AR appointed (if applicable), you can submit your application to us. Your application must match the conformity assessment route for your device's risk class under MDR Annex VIII.

You must assign a valid Basic UDI-DI through an authorised issuing entity (e.g., GS1) prior to submitting your application. By including your intended Basic UDI-DI(s), we can link certificate records correctly once issued.

Remember that refused applications are visible to all Notified Bodies, so a complete, well-prepared submission is in your interest.

Step 4: Register your devices and UDIs

New devices placed on the market after 28 May 2026 must be registered in the UDI/Device module before first market placement. For each device, you must register:

• Basic UDI-DI — the top-level identifier for a device family. 

• All UDI-DIs — for each model, variant, or packaging level within that family

• Risk class — under MDR Annex VIII

• Device attributes  — Intended purpose, trade name, model, EMDN code

• Member States where the device is marketed

• Certificate reference (NB number, certificate number, expiry date) for Class IIa and above

For devices placed on market before 28 May 2026 and still being marketed, the deadline to complete registration is 28 November 2026. This transitional timeline does not apply if a device is subject to a vigilance action, FSCA, or serious incident. In those cases, immediate registration is required.

Step 5: Keep your EUDAMED device data updated

From 28 May 2026, notified bodies must register all newly issued, refused, suspended, or withdrawn certificates in EUDAMED, and link each certificate record to your Basic UDI-DI.

You must keep your EUDAMED device data consistent with the certificate scope, and notify us promptly of any change that affects certificate validity.

Key deadlines

1. 28 May 2026 – now: Four modules mandatory. New devices must be registered before market placement. No grace period.

2. 28 November 2026: Legacy device registration deadline. Does not apply if the device is subject to vigilance action or FSCA.

3. 28 May 2027: Notified Bodies complete upload of legacy certificate data.

4. Q2 2027 (expected): Vigilance and Clinical Investigations modules are expected to become mandatory.

Readiness checklist:

For all manufacturers:

• Valid SRN obtained and included in your application documentation

• Basic UDI-DI registered in EUDAMED for all devices in scope

• EUDAMED device data consistent with technical documentation, labelling, and IFU

• EMDN codes assigned to all devices

• Legacy device registration plan in place ahead of November 2026

For non-EU manufacturers:

In addition to the above, you'll need:

• EU Authorised Representative appointed, registered in EUDAMED, and holding a valid SRN

• AR’s name and address on device labelling

• Device registration confirmed as the manufacturer’s responsibility (not the AR’s)

If you’re unsure whether your EUDAMED registration is complete before submitting, don’t hesitate to contact your Notified Body. A well-prepared application benefits everyone.

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Sarah Burley works in Scarlet's Technical Operations team, with a focus on certification operations. She has been closely tracking the transition to mandatory EUDAMED use under the EU MDR.