Submission

Overview

The Submission flow in UDI Hub is started from UDI Management, typically from the Basic UDI-DI Status Overview page. From there, you can:

submit a Basic UDI-DI (BUDI) and one device for an Initial Registration
automatically queue (waitlist) additional devices for submission once the initial registration is accepted
submit additional devices later as Follow Up / New Device
submit updates for either the Basic UDI-DI or for individual devices (after initial registration)

Basic UDI-DI Status Overview (Dashboard)

Step-by-step: Start a Submission from UDI Management

1. Open the Basic UDI-DI and view assigned devices

In Basic UDI-DI Status Overview, select a Basic UDI-DI card.
The assigned devices for this Basic UDI-DI are shown on the right side.

Click Basic UDI-DI card to display assigned devices

2. Select what you want to submit (BUDI and/or devices)

Use the checkboxes to select:

the Basic UDI-DI (left)
one or more devices (right)

At the bottom you’ll see a running selection counter (e.g., 4 items selected).

3. Start the guided flow with Review & Submit

Click Review & Submit to open a guided modal.
This modal validates your selection, explains what will happen, and lets you submit.

Step A — Select target market (currently EUDAMED)

First, confirm the target authority/market.
Today the flow shows EUDAMED, but the UI is designed to support multiple authorities later.

Review & Submit - Select target market (EUDAMED)

Click Continue.

Initial Registration: Basic UDI-DI + paired Device (EUDAMED rule)

If your selection includes a Basic UDI-DI that has never been successfully submitted to EUDAMED, the modal runs the Initial Registration path.

Step B — BUDI validation & submission type (INITIAL)

UDI Hub validates that the Basic UDI-DI is:

in a Ready for Submission state, and
eligible for the required submission type

For an INITIAL registration, EUDAMED allows submission of:

1 Basic UDI-DI + exactly 1 device (paired device)

Therefore, UDI Hub asks you to select the paired device for the initial registration:

the system automatically preselects the first valid device
you can change the paired device here if needed

BUDI validation (INITIAL) and device pairing

Click Continue.

Step C — Device validation, grouping, and waitlisting

Next, UDI Hub validates the selected devices and groups them by their parent Basic UDI-DI. In an Initial Registration scenario:

the paired device will be submitted now
any additional selected devices are placed in a QUEUE / Waitlist

Waitlisted (Queued) devices will be submitted automatically as follow-up registrations after the initial paired BUDI/device submission has been accepted by EUDAMED.

Device validation with paired device and waitlisted devices

Click Continue to reach the summary and then submit.

Step D — Submit to EUDAMED

In the final step, review the summary and click Submit to EUDAMED to initialize the submission.

After submission, a success card confirms which submission types were started.

Observe the process (Refresh)

Back on the overview page, you can use Refresh to observe status changes:

the paired Basic UDI-DI + device go In Submission
once successful, they switch to Published
waitlisted devices are then automatically triggered and submitted

Waitlisted devices while initial submission is in progress

When waitlisted devices are triggered, you will see the follow-up submission start automatically:

Automatic submission of waitlisted devices

Finally, devices also switch to Published after successful processing.

Published state after successful submissions

Follow Up: Submit additional devices as NEW DEVICE

After a Basic UDI-DI is successfully Published, you can submit additional devices later as a Follow Up.

What changes compared to INITIAL?

you select devices only (no Basic UDI-DI selection required)
the BUDI step is skipped in the modal
devices are labeled as NEW DEVICE
devices are submitted directly (no waitlist needed if BUDI is already published)

In the Devices step, UDI Hub lists the devices under the parent Basic UDI-DI and marks them as:

SUBMIT NOW
NEW DEVICE

Proceed through the summary:

And submit:

Working strategy

You can either submit all devices at once (managed via Waitlisted during INITIAL) or submit devices in portions via follow-ups.
For reliability, currently keep each batch ≤ 500 devices while performance optimizations are ongoing.

Updates after initial registration (BUDI and devices become independent)

After the initial registration is successful (BUDI and at least one device are Published):

Basic UDI-DI and Devices are considered decoupled for updates
you can submit BUDI updates and device updates independently
each update creates a new Registration Version for the updated entity

How updates are triggered

Typically, an update starts when you change data via Excel upload/import:

Maintenance Status changes (e.g., to Approved)
Submission Status becomes Ready for Submission

Example: Basic UDI-DI update

If the Basic UDI-DI is Ready for Submission, select the Basic UDI-DI and click Review & Submit.

Basic UDI-DI moved back to Ready for Submission after data changes

In the modal, only the BUDIs step is relevant and the item is labeled as BUDI UPDATE.

After successful submission, the Basic UDI-DI switches to:

Registration Status: Updated
Registration Version: 2 (or higher for subsequent updates)

BUDI update successful: Updated, version 2

Blocked / excluded items and filtering

UDI Hub can validate mixed selections (BUDIs and/or devices).
If some items cannot be submitted (e.g., invalid status or rule violations), the modal highlights them as excluded.

Blocked BUDI example

Blocked device example

If your selection contains both submittable and non-submittable items, UDI Hub offers to:

Review Excluded Items (inspect the issues), or
Filter and Continue (proceed only with valid items)

Important note: High Risk devices with certificates (feature gap)

For Basic UDI-DIs / devices where certificates are provided and a Notified Body approval is required, the end-to-end status synchronization is not fully implemented yet. Current behavior:

the item may remain in Submitted
follow-up updates may be blocked until the authoritative status is retrieved

Planned improvement:

a GET Device Status feature to pull the final status back into UDI Hub automatically

Known limitation

If certificates / Notified Body approval are involved, UDI Hub may currently not transition items from Submitted to Published automatically.
This can prevent subsequent updates until status retrieval is available.

Submission types & concepts (cheat sheet)

Concept / Label	When it happens	What it means	Typical system behavior
INITIAL	First ever successful EUDAMED registration for a Basic UDI-DI	EUDAMED requires 1 BUDI + 1 paired device	You must pick a paired device; only that pair is submitted immediately
QUEUED / Waitlisted	During INITIAL, when you selected additional devices	Devices are queued for later follow-up once INITIAL is accepted	Devices stay Waitlisted and are triggered automatically after BUDI + paired device become Published
Follow Up / NEW DEVICE	Adding devices to an already published Basic UDI-DI	New device registration under an existing BUDI	Devices are labeled NEW DEVICE and can be submitted directly
BUDI UPDATE	After data changes to a published Basic UDI-DI	Update of the Basic UDI-DI registration	Registration version increases (e.g., 2) and status becomes Updated
Device Update	After data changes to a published device	Update of an individual device registration	Device can be updated independently from the BUDI (after initial registration)

Tip

For an INITIAL registration, decide early whether you want to submit all devices at once (managed via waitlisting) or in smaller follow-up batches.
Until performance improvements are complete, stay below 500 devices per submission for best reliability.

Introduction

Getting Started

Features

Info Section