EUDAMED user guide

UDI Devices

Production v 2.9
October 2022
 EUDAMED user guide

Table of Contents
1. Introduction ............................................................................. 1
2. Getting started ........................................................................ 2
3. Registering Regulation Devices .............................................. 3
3.1. Registration of a Basic UDI-DI together with a UDI-DI
of a Regulation device .......................................................... 3
3.1.1. Step 1: Basic UDI-DI identification information ..... 3
3.1.2. Step 2: Certificate information (when
applicable) ....................................................................... 6
3.1.3. Step 3: UDI-DI identification information ............... 7
3.1.4. Step 4: UDI-DI Characteristics .............................. 9
3.1.5. Step 5: Device Information .................................. 12
3.1.6. Step 6: Container Package Details ..................... 16
3.2. Registration of a UDI-DI for an existing Basic UDI-DI
of a Regulation device ........................................................ 18
4. Registering Legacy Devices ................................................. 21
4.1. Step 1: EUDAMED DI identification information .......... 22
4.2. Step 2: Certificate information ...................................... 24
4.3. Step 3: Device identification information ...................... 24
4.4. Step 4: Device Characteristics ..................................... 26
4.5. Step 5: Device Information ........................................... 27
5. Registering System or Procedure Packs (SPP) ................... 29
5.1. Registration of a Basic UDI-DI together with a UDI-DI
for a System or Procedure Pack ......................................... 29
5.1.1. Step 1: Basic UDI-DI main information ............... 29
5.1.2. Step 2: Basic UDI-DI information ........................ 31
5.1.3. Step 3: UDI-DI identification information ............. 32
5.1.4. Step 4: UDI-DI Characteristics ............................ 35
5.1.5. Step 5: Container Package Details ..................... 36
5.2. Registration of a UDI-DI for an existing Basic UDI-DI
of a System or Procedure Pack .......................................... 38
5.2.1. Step 1: UDI-DI identification information ............. 39
5.2.2. Step 2: UDI-DI Characteristics ............................ 40
5.2.3. Step 3: Container Package Details ..................... 41
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6. Manage your own Device Information .................................. 42

6.1. Manage your device Basic UDI-DI/EUDAMED DI
details .................................................................................. 42
6.1.1. Delete a Draft Basic UDI-DI/EUDAMED DI ......... 43
6.1.2. Update (Create new version) for Basic UDI-DI/
EUDAMED DI ................................................................ 44
6.1.3. View historical versions for Basic UDI-DI/
EUDAMED DI ................................................................ 46
6.2. Manage your device UDI-DI/EUDAMED ID details ...... 47
6.2.1. Delete a draft UDI-DI/EUDAMED ID ................... 49
6.2.2. Update (Create a new version) for UDI-DI/
EUDAMED ID ................................................................ 49
6.2.3. Update (Create new version) for Product
Designer (designed and manufactured by another
legal or natural person) ................................................. 50
6.2.4. Update (Create new version) for Market
information .................................................................... 51
6.2.5. Update (Create new version) for Container
Packages ...................................................................... 53
6.2.6. Discard registered UDI-DIs/EUDAMED IDs (and
their Basic UDI-DI/EUDAMED DI) ................................. 55
6.2.7. View historical versions of UDI-DI/EUDAMED ID
and associated entities .................................................. 56
7. Manage your own System or Procedure Pack (SPP)
information ................................................................................ 59
7.1. Manage your SPP Basic UDI-DI details ....................... 59
7.1.1. Delete a Draft Basic UDI-DI ................................ 60
7.1.2. Update (create new version) for Basic UDI-DI .... 61
7.1.3. View historical version for Basic UDI-DI .............. 63
7.2. Manage your SPP UDI-DI details ................................ 64
7.2.1. Delete a Draft UDI-DI .......................................... 66
7.2.2. Update (create new version) for UDI-DI .............. 67
7.2.3. Update (create new version) for Container
Packages ...................................................................... 69
7.2.4. Discard SPP Registered UDI-DIs ........................ 71
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7.2.5. View SPP historical versions for UDI-DI and

associated entities ......................................................... 72
8. Search & View Devices, Systems and/or Procedure Packs . 74
8.1. Search & View historical versions of Devices,
Systems and Procedure Packs ........................................... 76
8.2. Download Devices or Systems or Procedure Packs
data in a structured format (XML) ....................................... 77
8.3. View historical versions for Basic UDI-DI/EUDAMED
DI, UDI-DI/EUDAMED ID and associated entities .............. 79
9. Annex 1 – Device Certificate Information ............................. 83
10. Annex 2 – Legacy Device Certificate Types ....................... 84
 EUDAMED user guide

1 Introduction
Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro
diagnosis medical devices introduce an EU identification system for medical devices
based on a Unique Device Identifier (UDI).

The UDI-DI/Device module of EUDAMED is used for the manufacturers to provide their
UDIs/Devices information and to make it available to everyone.1

1For
a wider understanding on how to use the website, including FAQs and process infographics, visit the
EUDAMED Information Centre.

Introduction 1
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2 Getting started
What I need to access EUDAMED:

1. EU Login (ECAS) account

To use EUDAMED, you must have an EU Login account associated with your professional
email address and the manufacturer for which you want to act on behalf must be
registered as an actor in EUDAMED.

2. User profile registration in EUDAMED

For information on how to gain access to EUDAMED, please consult the user guide for
Economic Operators (EO) available for download on the EUDAMED landing page.

NOTE
EUDAMED is also available in a Playground environment, intended to enable you
to experiment with the application. All the information in this environment is dummy
(including the Actor ID/SRN) and will never be moved to the production environment.
Access to the Playground requires a separate registration.

Every user in EUDAMED is granted by default the profile “Viewer” for the UDI/Device
module, and can search and view registered devices. However, to enter UDI/Device data
in EUDAMED, you must request access for the UDI/Device module with a higher profile2
as either:

• A “Proposer” – this profile allows you to create and delete draft records related to your
manufacturer, or

• A “Confirmer” – this profile includes the Proposer rights and additionally, allows you to
submit and discard records.

IMPORTANT
A Local Actor Administrator (LAA)/Local User Administrator (LUA) of your manufacturer
must approve your user access request for your profile(s) to be granted.

Before you start entering details of a UDI/device in EUDAMED, please make sure
that you have all requested information at hand, including firstly the Basic UDI-DI and
UDI-DI codes. Fields marked with a red asterisk are mandatory.

2See the Economic Operator user guide, Section 1.2.3, for more information on user rights and profiles.

Getting started 2
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3 Registering Regulation
Devices
Each regulation device must have a unique Basic UDI-DI and a unique UDI-DI assigned
to it. Both are always required – you cannot register a Basic UDI without a UDI-DI.

You will be asked to enter EUDAMED via your EU Login account.

3.1 Registration of a Basic UDI-DI

together with a UDI-DI of a Regulation
device
3.1.1 Step 1: Basic UDI-DI identification information
1. Click on Register a new Basic UDI-DI:

2. On the next page, enter the Basic UDI-DI information. Select the applicable
regulation.

NOTE
In this guide demonstration, the selection is MDR (Regulation (EU) 2017/745).
Based on the regulation you choose, the characteristics of the Device to be
entered will vary.

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Depending on the regulation that you have selected an additional question appears at
the bottom of the page:

Regulation Additional question

MDR Is it a System or Procedure Pack which is a Device in itself?

+ additional sub-questions about the device type, depending on whether your answer is "Yes" or "No" to this first question
IVDR Is it a kit?

+ additional sub-question about the device type, if you answer "No" to this first question

If you select “No”, please choose the right information under the appearing section
“Special Device type” (for IVDR, if you select “No” for “Is it a Kit?”, the only option for
Special device type if applicable is “Software”):

3. Fill in the Basic UDI-DI identification details and click on “Save & Next”:

IMPORTANT
EUDAMED will validate the Basic UDI-DI code based on the specific format for
each Issuing Entity and will prevent you from going further if the code is not valid.

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If the Basic UDI-DI code already exists in EUDAMED, the system will prevent you
from saving, as a Basic UDI-DI must be unique.

4. Non-EU Manufacturers will have to select the authorised representative for the
Basic UDI-DI amongst those with which they have an active mandate registered in
EUDAMED.
If there is only one authorised representative with an active Mandate with the non-EU
manufacturer, it will be automatically retrieved:

5. Choose a Risk Class and select “Yes” or “No” for each option that follows.

6. Select “Yes” or “No” if Device model is applicable. If the Device model is not
applicable, the Device Name will be mandatory, otherwise, it is mandatory to enter
the Device model and the Device name (at the Basic UDI-DI level) if there is one
(note that the device trade name is part of the UDI-DI data):

7. Click on “Save” to save your registration as a draft and continue at a later point, or on
“Save & Next” to save it as a draft and continue with the following steps:

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3.1.2 Step 2: Certificate information (when applicable)

This section will become active depending on the information provided for Risk Class and
additional properties in the Basic UDI-DI.

In the case of certificate information, at least the following should be provided:

• whether “EU type examination certificate” is applicable.

• the Notified Body (NB) responsible for the product certificate

• if known, the certificate identification.

Additionally, more information on the certificate type could be required depending on the
risk class and properties specified for the Basic UDI-DI. For the NB, enter some or all of
the NB name or number, click “Find” and choose the correct Notified Body from the new
window.

If known, enter the certificate number and revision number and click on “Save” or “Save &
Next”.

NOTE
Certificate Information for a Basic UDI-DI registration is applicable only when its
confirmation by the Notified Body from the certificate registration is required (as
specified in Art 29(3) MDR/Art 26(2) IVDR).

In Annex 1 [83] – Device Certificate Information [83] you can find the different cases
in which Certificate information is needed and the type of certificate. (In summary, it is
applicable for MDR risk class III and IIb and IVDR risk class B with self-patient testing/
near-patient testing, risk class D and C).

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3.1.3 Step 3: UDI-DI identification information

1. Select the “Issuing Entity” from the drop-down list and enter the UDI-DI code.

IMPORTANT
The UDI-DI code you enter must be unique. If it already exists in EUDAMED, you
will not be able to Save.

Exception: the same UDI-DI can be used for a Legacy Device and its Regulation
Device equivalent.

If the same UDI-DI code was already provided for a Legacy Device (i.e. Applicable
Legislation MDD, AIMDD or IVDD), you will be prompted that a link will be created
between the two devices (the Regulation and the Legacy Device) on the condition
there is no conflict between some of the Basic UDI-DI properties and the related
legacy device EUDAMED DI properties. In case of conflict, the system will prevent
you from using the same UDI-DI.

NOTE
In the case of a GS1 Issuing Entity, the UDI-DI code you enter must be a 14-digit
code including the check digit that will be used by EUDAMED to validate the
UDI-DI code. If your GS1 UDI-DI (GTIN code) is less than 14 digits (check digit
included), when populating EUDAMED field, please add leading zero(s) until you
reach 14 digits.

For example:

000000nnnnnnnn (GTIN-8)

00nnnnnnnnnnnn (GTIN-12)

0nnnnnnnnnnnnn (GTIN-13)

2. If applicable, enter the Secondary UDI-DI from a different Issuing Entity to the UDI-DI:

3. Enter the EMDN code and click on “Find”, and select the correct one from the list:

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4. If applicable, enter the trade name (as specified on the device label) and select its
related language (select “All languages” if not language dependent):

5. Enter the Reference/Catalogue number:

6. Specify whether the device is directly marked or not:

• If the device is directly marked, you must either indicate it is the same as the
UDI-DI or enter the UDI-DI and issuing entity of the Direct marking DI.

7. If the device is not directly marked and the base quantity of the device is greater than
one, you may enter the Unit of Use DI and its issuing entity:
• The same Unit of Use DI can be used for different UDI-DIs in case the same device
has different root packaging (having each one a different UDI-DI).

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8. Select the type of UDI-PI:

9. Enter any additional information you think important to specify about the device,
select the language in which the additional information is provided and enter a URL
(web address) if you have one for additional information online:

10. Specify the UDI-DI status in selecting whether it is “On the EU market” or “Not
intended for the EU market” and click on “Save” or “Save & Next”:

3.1.4 Step 4: UDI-DI Characteristics

1. If applicable, specify clinical size for the UDI-DI and choose the dimension and the
precision values in the drop-down lists below:

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NOTE
When the selected Clinical size type has the option ‘Other’, users will be required
to enter the Description of the Clinical size type and the language in which the
description is given. The same applies for Measure unit.

In case both the Clinical size and Measure unit have the option ‘Other’, the
description for the two fields needs to be given in the same languages.

You shall provide one of the following precision type:

• Range – requires a minimum and maximum values and the measure unit

• Text – requires free text entry

• Value – requires the size and the measuring unit

You may add several clinical sizes by adding different types of dimension, but only
one dimension for a given type.

2. Specify if the device is labelled as single use.

When device is not labelled as single use you will be asked to provide the number of
reuses if applicable:
• If the ‘Maximum number of reuses’ is not applicable, then the device is considered
as a non-Single Use Device and the device does not have a maximum number of
reuses (infinite number of reuses)

• If value provided is >=1, the device is considered as a non-Single use Device

having a limited number of reuses (the value provided)

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3. Select “Yes” or “No” for each of the options below:

‘Containing latex’ is only for MDR, not applicable for IVDR.

4. For MDR, if applicable, enter the CMR and/or Endocrine disruptor substances. When
specifying CMR and/or Endocrine substances you have the option to provide the EC#
or CAS#. If you do provide them, only the Name of substance is required (i.e. the
language is no longer required):

5. If applicable, the Storage/handling conditions; choose the correct information from the
list and provide a description where relevant:

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NOTE
When the selected Storage/handling conditions type has the option ‘Other’, users
will be required to enter the Description of the Storage/handling condition type and
the language in which the description is given.

6. Do the same for Critical warnings or contra-indications, and click “Save” or “Save &
Next”:

NOTE
When the selected Critical warning or contra-indications type has the option
‘Other’, users will be required to enter the Description of the Critical warning or
contra-indications type and the language in which the description is given.

3.1.5 Step 5: Device Information

1. For MDR, specify whether it is a reprocessed single use device and whether it has an
Intended purpose other than medical (Annex XVI):

2. If you select “Yes” for the Intended purpose other than medical (Annex XVI), possible
options will appear. Select the relevant purpose(s):

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3. Select “Yes” or “No” if the device was designed and manufactured by another legal or
natural person.
If "Yes", enter the Actor ID/SRN or name of the other legal or natural person that
designed and manufactured the device. Click “Find” to see the search outcome. If
registered as manufacturer in EUDAMED, the system will provide a list of matching
records from which you can select one, and the system will retrieve the information:

4. If you cannot find the other legal or natural person that designed and manufactured
the device because they are not registered as a manufacturer in EUDAMED, uncheck
the box “I know the SRN” and complete the required fields with the details on the
other legal or natural person that designed and manufactured the device:

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5. Select “Yes” or “No” to provide the Clinical Investigation reference for the current
UDI-DI:

6. When registering under MDR, select “Yes” or “No” to complete information on tissues
and cells, and information on substances:

If you answer “Yes” to Information on substances, enter the details:

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For IVDR, select “Yes” or “No” to complete information on tissues and cells, in
addition you shall specify if the device is new:

NOTE
A device shall be considered ‘new’ if:

a. There has been no such device continuously available on the Union market
during the previous three (3) years for the relevant analyte or other parameter.

b. The procedure involves analytical technology not continuously used in

connection with a given analyte or other parameter on the Union market
during the previous three (3) years.

7. Choose a Country in the drop-down list where the device is or has been first placed
on the EU market, and click “Save” or “Save & Next”:

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NOTE
The countries where the device is or is to be made available on the market are
mandatory, to be provided when the device’s status is ‘On the EU market’ and
device’s risk class is not risk class I (MDR) and not risk class A (IVDR).

3.1.6 Step 6: Container Package Details

1. Click on “Add container package” when there is a higher packaging level for the root
UDI-DI:

A unique UDI-DI must be assigned to each package level. You add a higher container
package to the root UDI-DI if no container package UDI-DI yet or to the selected
UDI-DI (you can add as many levels and as many container packages per level
as you have). Add the Issuing Entity, Package UDI-DI code and the quantity per
package, and click on “Save”:

NOTE
If the UDI-DI already exists in EUDAMED, the system will prevent you from
saving.

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2. Select the generated information and click on “Submit”:

3. A pop-up window will appear asking you to confirm your submission:

4. You will be redirected to a new page saying you successfully submitted your
registration:

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IMPORTANT
After submitting the Device, the state of the Device (Basic UDI-DI and UDI-DI) will
be:

• Registered, if the Basic UDI-DI data does not require a confirmation from the
Notified Body (Basic UDI-DI and UDI-DI are publicly available in the EUDAMED
public website);

• Submitted, if the Basic UDI- DI data requires a confirmation from the Notified
Body (Basic UDI-DI and UDI-DI are not publicly available and will only
get the Registered state and become publicly available after Notified Body
confirmation).

3.2 Registration of a UDI-DI for an

existing Basic UDI-DI of a Regulation
device
1. On the EUDAMED Dashboard, select “Manage your Basic UDI-DIs/ EUDAMED
DIs”:

2. Filter the Basic UDI-DIs/ EUDAMED DIs in state Submitted or Registered:

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IMPORTANT
Additional UDI-DIs for a Basic UDI-DI can be added only for Regulation Devices
(not for Legacy Devices).

New UDI-DIs can be added only to Basic UDI-DIs that are in state Registered or
Submitted:

3. From the results, find the Basic UDI-DI for which you would like to add a new UDI-DI.
Click on the three dots on the right and click on ‘Add a new UDI-DI to this Basic
UDI-DI’:

4. Complete the series of steps required for the registration of a UDI-DI for an
existing Basic UDI-DI (Step 3: UDI-DI identification information [7], Step 4: UDI-DI

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Characteristics [9], Step 5: Device Information [12], Step 6: Container Package

Details [16]):

5. When you have completed all steps, click on ‘Submit my request’ to submit the new
UDI-DI:

IMPORTANT
After Submitting the UDI-DI, the state of the UDI-DI will be:

• Registered if the Basic UDI-DI has the state Registered;

• Submitted if the Basic UDI-DI has the state Submitted.

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4 Registering Legacy
Devices
On the dashboard, click on “Register a Legacy device”:

INFOGRAPHIC: Identifiers of a legacy device

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4.1 Step 1: EUDAMED DI identification

information
1. Select the applicable legislation:

2. Select “Yes” or “No” to whether a UDI-DI is already assigned to the legacy device. If
yes, enter the Issuing Entity and the UDI-DI code, and click “Generate”. EUDAMED
will create a corresponding EUDAMED DI (the UDI-DI code with “B-“ as prefix).

NOTE
In the case of a GS1 Issuing Entity, the UDI-DI code you enter must be a 14-digit
code including the check digit that will be used by EUDAMED to validate the
UDI-DI code. If your GS1 UDI-DI (GTIN code) is less than 14 digits (check digit
included), when populating EUDAMED field, please add leading zero(s) until you
reach 14 digits.

For example:

• 000000nnnnnnnn (GTIN-8)

• 00nnnnnnnnnnnn (GTIN-12)

• 0nnnnnnnnnnnnn (GTIN-13)

If the legacy device has no UDI-DI assigned to it, the EUDAMED DI must
be provided. The EUDAMED DI can be either assigned by the manufacturer
respecting the check digits rules or will be generated by EUDAMED during the
registration process from the manufacturer’s device identification by adding to it
the “B-“ prefix and the two characters check digits at the end.

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3. Non-EU manufacturers have to select the authorised representative (AR) for the
current device from the options available.

If there is only one AR with an active Mandate with the manufacturer, it will be
automatically retrieved:

4. On the left you will see a summary of the device characteristics.

Choose a “Risk class” from the list and select “Yes” or “No” for each of the options.

5. Select “Yes” or “No” if the device model is applicable and, if applicable, enter the
Device model and enter a Device name if there is one, otherwise enter only a Device
name:

6. Click on “Save” to save your draft and complete it later, or on “Save & Next” to save it
as a draft and continue with the following steps:

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4.2 Step 2: Certificate information

Select a certificate type, enter an NB number and click “Find”. Enter the certificate
number and expiry date. If available, enter a revision number.

NOTE
Information on active certificates must be provided for Legacy Devices. Legacy devices
could have no certificate information only in case a certificate would be required only
under MDR/IVDR (like for class I reusable surgical instruments).

In Annex 2 [84] to this document you may find the certificate types that can be
provided for the Legacy Devices specific for each applicable legislation of the Device.

Several identification details for several certificates can be entered:

4.3 Step 3: Device identification

information
EUDAMED will display the identifier of the Device (the previously provided UDI-DI or the
EUDAMED ID generated based on the provided/generated EUDAMED DI. EUDAMED ID
has the same code as the EUDAMED DI, except that it is with a “D-“ prefix instead of the
“B-“ prefix):

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1. Enter the EMDN code. Click on “Find” and select the correct one:

2. If applicable, enter the trade name and select the language, otherwise select “No":

3. Enter a reference/catalogue number and any additional information you might have:

4. EUDAMED will display the status of the Device.

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NOTE
In the case of Legacy Devices, the initial status of the Device is considered to be
‘On the market’.

4.4 Step 4: Device Characteristics

1. Select “Yes” or “No” for the first three options, then select “Yes” or “No” whether if
Storage/handling conditions are applicable:

2. If applicable, provide the correct values by selecting from the options provided and
enter a description:

3. Select “Yes” or “No” for Critical warnings or contra-indications and if “Yes”, enter the
type and description. After completing, click on “Save” or “Save & Next”:

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4.5 Step 5: Device Information

1. Select “Yes” or “No” if the device was designed and manufactured by another legal or
natural person, and enter the SRN number if you know it:

If you do not know the ActorID/SRN, uncheck the box and complete the required
fields:

2. Select “Yes” or “No” to provide the Clinical Investigation reference:

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3. Select “Yes” or “No” for the three following options on Tissues and cells:

4. Select a Country from the drop-down list where the device has been placed on the
EU market, and click on “Submit” to submit it directly or “Preview” to view before
submitting:

5. A pop-up window will appear asking you to confirm your submission. Once you
confirm, you will be brought to a new window confirming the submission of your
Legacy device:

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5 Registering System or
Procedure Packs (SPP)
5.1 Registration of a Basic UDI-DI
together with a UDI-DI for a System or
Procedure Pack
Registering System or Procedure Packs is only possible for users belonging to an actor
that is a System and Procedure Pack producer.

5.1.1 Step 1: Basic UDI-DI main information

1. On the EUDAMED dashboard, click on “Register a New System Procedure Pack”:

2. On the next page, specify the Issuing entity and the Basic UDI-DI code:

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NOTE
Only the applicable legislation MDR (REGULATION (EU) 2017/745 on medical
devices) is possible for system and procedure packs (selected by default).

IMPORTANT
EUDAMED will validate the Basic UDI-DI code you insert based on the specific
format provided by each Issuing Entity. Please ensure that you enter the correct
code with the check digits.

If the Basic UDI-DI code already exists in EUDAMED, the system will prevent you
from saving – a Basic UDI-DI must be unique:

3. Choose if you are registering a system or procedure pack and click on “Save & Next”
to save your registration as a draft and move on to the next steps:

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5.1.2 Step 2: Basic UDI-DI information

On the next page, enter the Basic UDI-DI information:

1. Choose a 'Risk Class' from the drop-down list (the risk class must be the highest risk
class of devices that are parts of the system or procedure pack):

2. Fill in the indication of medical purpose and select the related language from the
drop-down list.

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If you add the indication in several languages, click on “Add another indication of
medical purpose” and select its language.
Select “Yes” or “No” if Device model is applicable and, if applicable, enter the Device
model and a device name if there is one. Otherwise, enter only a Device name):

3. Click on “Save” to save your registration as a draft and come back to it later, or click
on “Save & Next” to save it as a draft and continue to the next steps:

5.1.3 Step 3: UDI-DI identification information

1. Select the “Issuing Entity” from the drop-down list and enter the UDI-DI code:

IMPORTANT
The UDI-DI code you enter must be unique. If it already exists in EUDAMED, you
will not be able to Save.

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NOTE
In the case of a GS1 Issuing Entity, the UDI-DI code you enter must be a 14-digit
code including the check digit that will be used by EUDAMED to validate the
UDI-DI code. If your GS1 UDI-DI (GTIN code) is less than 14 digits (check digit
included), when populating EUDAMED field, please add leading zero(s) until you
reach 14 digits.

For example:

• 000000nnnnnnnn (GTIN-8)

• 00nnnnnnnnnnnn (GTIN-12)

• 0nnnnnnnnnnnnn (GTIN-13)

2. If applicable, enter the Secondary UDI-DI from a different Issuing Entity to the UDI-DI:

3. Enter the EMDN code and click on “Find”, and select the correct one from the list:

4. If applicable, enter the trade name enter the trade name (as specified on the
device label) and select its related language (select “All languages” if not language
dependent):

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5. Enter the Reference/Catalogue number:

6. Select the type of UDI-PI:

7. Enter any additional information you think important to specify about the System or
Procedure Pack, select the language in which the additional information is provided
and enter a URL (web address) if you have one for additional information online:

8. Specify the UDI-DI status in selecting whether it is “On the EU market” or “Not
intended for the EU market” and click on “Save” or “Save & Next”:

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5.1.4 Step 4: UDI-DI Characteristics

1. Select “Yes” or “No” for each option regarding sterilisation:

2. If Storage/handling conditions are applicable, slide the toggle to "Yes". Choose the
correct information from the list and provide a description where relevant:

NOTE
When the selected Storage/handling conditions type has the option ‘Other’, users
will be required to enter the Description of the Storage/handling condition type and
the language in which the description is given.

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3. Do the same for Critical warnings or contra-indications, and click “Save” or “Save &
Next”:

NOTE
When the selected Critical warning or contra-indications type has the option
‘Other’, users will be required to enter the Description of the Critical warning or
contra-indications type and the language in which the description is given.

4. Click on “Save” to save draft and finish later or “Save & Next” to move directly to the
next step of the process:

5.1.5 Step 5: Container Package Details

1. Click on “Add container package” when there is a higher packaging level for the root
UDI-DI:

A unique UDI-DI must be assigned to each package level. You add a higher container
package to the root UDI-DI if there is no container package UDI-DI yet, or to the
selected UDI-DI (you can add as many levels and as many container packages per
level as you have). Add the Issuing Entity, Package UDI-DI code and the quantity per
package, and click on “Save”:

NOTE
If the UDI-DI already exists in EUDAMED, the system will prevent you from
saving.

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2. Select the generated information and click on “Submit”:

3. As a final step, a pop-up window will appear, asking you to confirm that you are ready
to submit your registration request. If so, click on "Submit my Request”:

Upon submission, you will see a message that you have successfully submitted a
SPP registration request:

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5.2 Registration of a UDI-DI for an

existing Basic UDI-DI of a System or
Procedure Pack
1. On the Dashboard, select “Manage your Basic UDI-DIs”:

2. Filter the Basic UDI-DIs with the state “Registered”:

To do that click on the button “Filter”, then select “Registered” in the “State” box and
then click on the button “Apply filter":

New UDI-DIs can be added only for Basic UDI-DIs in state Registered or Submitted.

3. Identify the Basic UDI-DI for which you would like to add a new UDI-DI and click on
the ellipsis symbol to add it:

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5.2.1 Step 1: UDI-DI identification information

1. Complete all the necessary information in the UDI-DI identification information tab:

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2. Click on “Save & Next” to move to the next step:

5.2.2 Step 2: UDI-DI Characteristics

1. Fill in the fields for the UDI-DI Characteristics tab:

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2. Click on “Save & Next” to move directly to the next step (or click on “Save” to save
your draft for later).

5.2.3 Step 3: Container Package Details

To complete this step, please consult Section 5.1.5 [36] of this guide.

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6 Manage your own Device

Information
6.1 Manage your device Basic UDI-DI/
EUDAMED DI details
1. On the dashboard, click on “Manage your Basic UDIs/EUDAMED DIs”:

2. You will see a list with all of the Basic UDI-DIs /EUDAMED DIs registered to the
current actor:

NOTE
By default, the Basic UDI-DIs/EUDAMED DIs listed are the ones in draft state. To
retrieve Basic UDI-DIs/EUDAMED DIs in other states, use the filters.

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3. Click on the three dots on the right of the desired entry and then click on “View Data”
from the list:

4. You will see a summary of the details concerning your Basic UDI-DI/EUDAMED DI:

6.1.1 Delete a Draft Basic UDI-DI/EUDAMED DI

After following steps 1, 2 and 3 from Manage your device Basic UDI-DI/EUDAMED DI
details [42] to view a Draft Basic UDI-DI/EUDAMED DI in state 1st Draft, you have the
option to delete this draft.

1. When you are inside the View details page of the desired 1st draft, click on “Delete”:

A pop-up will ask you to confirm the delete action:

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The system also warns about deletion of the UDIs under the 1st draft device.

2. To delete a draft version of a device open the View details page of the device. The
system will display the existing draft version. Click on "Delete":

A pop-up will ask you to confirm the delete action:

6.1.2 Update (Create new version) for Basic UDI-DI/

EUDAMED DI
Follow the steps in section Manage your device Basic UDI-DI/EUDAMED DI details [42] to
view a Basic UDI-DI/EUDAMED DI.

1. Once inside the details page for the desired Basic UDI-DI, click on “Create new
version” on the top right corner:

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2. Update the desired details:

3. To complete the action:

a. Click on Save” to save to your registration as a draft and continue at a later point.

b. Click on “Submit new version”, if you are certain about the update and wish to
submit it.

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Alternatively, click on “Cancel” to cancel the update.

6.1.3 View historical versions for Basic UDI-DI/

EUDAMED DI
Follow the steps in section Manage your device Basic UDI-DI/EUDAMED DI details [42] to
view a Basic UDI-DI/EUDAMED DI.

1. Once inside the details of the selected Basic UDI-DI, click on “See version history”:

2. View the list of versions for the desired Basic UDI-DI and click on the version you
wish to view:

3. Inside a version, you can browse through the different versions by clicking on the
arrows on the top right corner:

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6.2 Manage your device UDI-DI/EUDAMED

ID details
1. On the dashboard of EUDAMED, click on “Manage your Device details”:

2. You will see a list:

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NOTE
By default, the system lists the devices in Draft” state. To retrieve other states use
the filters:

3. Click on the three dots symbol on the right of the desired entry and then click on
“View data”:

4. You will see a summary of the details of your device:

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6.2.1 Delete a draft UDI-DI/EUDAMED ID

Follow the steps in Manage your device UDI-DI/EUDAMED ID details [47] to view a Draft
UDI-DI.

1. Once inside the desired Draft UDI-DI, click on “Delete”:

2. A pop-up message will ask you to confirm the delete action:

6.2.2 Update (Create a new version) for UDI-DI/

EUDAMED ID
Follow the steps in section Manage your device UDI-DI/EUDAMED ID details [47] to view
a UDI-DI/EUDAMED ID.

1. Once inside the details of the selected UDI-DI, click on “Create new version” and
proceed to update:

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2. To finish the action you have two options:

a. “Save” to save the updated details without submitting the new version.
b. “Submit new version”, if you wish to finalise the update.

6.2.3 Update (Create new version) for Product Designer

(designed and manufactured by another legal or natural
person)
The Product Designer information can be updated independently of the other data in a
device UDI-DI record.

1. Follow the steps in section Manage your device UDI-DI/EUDAMED ID details [47] to
view a UDI-DI/EUDAMED ID.

2. Once inside the details of the selected UDI-DI, click on “Product Designer” from the
list on the left (or scroll down to the Product Designer section):

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3. Click on “Update”:

4. Update the information under Product Designer:

5. Click on “Submit” at the bottom of the screen to finalise the update.

You will be able to see the new version created for the Product Designer information.

6.2.4 Update (Create new version) for Market

information
The Market information can be updated independently of the other data in a device UDI-DI
record.

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1. Follow the steps in section Manage your device UDI-DI/EUDAMED ID details [47] to
view a UDI-DI/EUDAMED ID.

2. Once inside the details of the selected UDI-DI, click on “Market information” from
the list on the left (or scroll down to the Market information section):

3. Click on “Update countries”.

4. Update the relevant fields under Market information:

5. Click on “Submit” to finalise the update. You will be able to see the updated version
of Market information:

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6.2.5 Update (Create new version) for Container

Packages
The Container Packages information can be updated independently of the other data in a
device UDI-DI record.

1. Follow the steps in section Manage your device UDI-DI/EUDAMED ID details [47] to
view a UDI-DI/EUDAMED ID.

2. Once inside the details of the selected UDI-DI, click on “Container Package
information” from the list on the left (or scroll down to the relevant section):

3. Click on “Create new version” in the Container Package section and proceed to
update:

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4. Click on “Submit” to finalise the container package update:

6.2.6 Discard registered UDI-DIs/EUDAMED IDs (and

their Basic UDI-DI/EUDAMED DI)

IMPORTANT
The discard operation acts as a final deactivation. A device in state "Discarded" is
therefore not listed and cannot be viewed in the public site of EUDAMED. However, it
can be viewed by the MF (owner of the discarded device), CA and NB actors.

You may wish to discard a registered UDI-DI in case you discover errors that cannot be
corrected.

1. Follow the steps in section Manage your device UDI-DI/EUDAMED ID details [47] to
view a registered UDI-DI/EUDAMED ID.

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2. Once inside the details page of the selected UDI-DI, click on “Discard” on the top
right corner:

3. Confirm whether your wish to discard the registered UDI-DI:

The UDI-DI will be discarded and will no longer be visible on the public EUDAMED
website.

CAUTION
If the UDI-DI is the only one remaining in this Basic UDI-DI category, performing
the “discard” action will also discard the Basic UDI-DI. The system will alert you
accordingly:

6.2.7 View historical versions of UDI-DI/EUDAMED ID

and associated entities
Follow the steps in section Manage your device UDI-DI/EUDAMED ID details [47] to view
a UDI-DI/EUDAMED ID.

1. Once inside the details page of the selected UDI-DI, click on “See version history”
on the top of the table:

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You will see a list of all versions:

2. Click on the version you wish to view to access its details:

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3. You can return to the version history list, by clicking on “See all version history” on
the top right corner.

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7 Manage your own System

or Procedure Pack (SPP)
information
7.1 Manage your SPP Basic UDI-DI details
1. On the EUDAMED dashboard, click on “Manage your Basic UDI-DIs” to see a list of
all your Basic UDI-DIs:

NOTE
By default, the system displays the System or Procedure Packs in state “draft”. To
see other states, use the filters.

2. Click on the three dots of the selected entry and then click on “View data” from the
menu:

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3. You will see a summary of the details concerning your system or procedure pack:

7.1.1 Delete a Draft Basic UDI-DI

1. Follow the steps in section Manage your device Basic UDI-DI/EUDAMED DI
details [59] to view a Draft Basic UDI-DI:

2. Once inside the draft, click on “Delete”:

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3. A pop-up message will ask you to confirm the delete action:

7.1.2 Update (create new version) for Basic UDI-DI

Follow the steps in section Manage your device Basic UDI-DI/EUDAMED DI details [59] to
view a Basic UDI-DI:

1. Once inside the details page of the relevant Basic UDI-DI, click on “Create new
version”:

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2. Update the desired details.

NOTE
Only some details can be updated depending on the actor’s specifics:

3. To finish the action you have two options:

a. Click on "Save" to save the updated details without submitting the new version.
b. Click on "Submit new version" if you wish to submit it.
Alternatively, you can click on "Cancel" to cancel the update.

4. After you have submitted the new version, you can see the update under the Basic
UDI-DI details:

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7.1.3 View historical version for Basic UDI-DI

1. Follow the steps in section Manage your device Basic UDI-DI/EUDAMED DI
details [59] to view a Basic UDI-DI.

2. Once inside the details page for the selected Basic UDI-DI, click on “See version
history” at the top of the table:

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7.2 Manage your SPP UDI-DI details

1. On the EUDAMED dashboard, click on “Manage your UDI-DIs” to see the list:

2. In order to find the desired UDI-DI, click on the “Filter” button and choose the right
parameters:

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NOTE
By default, the Basic UDI-DIs/EUDAMED DIs listed are the ones in Draft state. To
retrieve other states, use the filters.

3. Click on the three dots of the desired entry and then click on “View data” from the
menu:

4. You will see a summary of the details concerning your chosen SPP UDI-DI:

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7.2.1 Delete a Draft UDI-DI

1. Follow the steps in section Manage your device UDI-DI/EUDAMED ID details [64] to
view a Draft UDI-DI.

2. Once inside the draft, click on “Delete”:

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3. A pop-up message will ask you to confirm the action:

7.2.2 Update (create new version) for UDI-DI

1. Follow the steps in Manage your device UDI-DI/EUDAMED ID details [64] to view a
UDI-DI.

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2. Once inside the details of the chosen UDI-DI, click on “Create new version” on the
top right corner:

3. Update the necessary details.

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NOTE
Only some details can be updated depending on the actor’s specifics:

4. To finish the action you have two options:

a. Click on “Save” to save the updated details without submitting the new version.
b. Click on “Submit new version”, if you wish to submit it.
Otherwise, you can press “Cancel” to cancel the update.

7.2.3 Update (create new version) for Container

Packages
The Container Packages information can be updated independently of the other data in a
System Procedure Pack (SPP) UDI-DI.

1. Follow the steps in section Manage your device UDI-DI/EUDAMED ID details [64] to
view a specific UDI-DI:

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2. Click on “Container Package information” from the list on the left (or scroll down to
the relevant section):

3. Click on “Create new version” in the Container Package section:

4. Click on “Add container package” to add new information about the packaging
format of the SPP:

5. Insert the package details in the pop-up window and click on “Save”:

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7.2.4 Discard SPP Registered UDI-DIs

1. Follow the steps in section Manage your device UDI-DI/EUDAMED ID details [64] to
view a chosen Registered UDI-DI:

2. Once inside the details page of the chosen UDI-DI, click on “Discard” on the top right
corner:

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3. The system will ask you to confirm if you wish to discard the record:

7.2.5 View SPP historical versions for UDI-DI and

associated entities
1. Follow the steps in section Manage your SPP UDI-DI details [64] to view a UDI-DI for
the SPP.

2. Once inside the details of the chosen UDI-DI, click on “See version history” on the
top of the table:

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3. You will see a list of all old versions:

4. Click on the version you wish to view to access its detailed summary:

You can return to the version history list by clicking on “See all version history” on
the top right corner.

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8 Search & View Devices,

Systems and/or Procedure
Packs
1. On the header menu, click on “Search & View”, then “UDI-DIs/Devices”:

Alternatively, use the option available in the dashboard called ‘Search & View’:

2. EUDAMED will show the filters available for searching in the list of Devices, Systems
and/or Procedure Packs (SPP) registered (or, for competent authorities and notified
bodies, submitted or discarded) in EUDAMED:

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3. Once you have entered your search filters, click on “Search” (the record will have to
match all the filters). A list of Devices (UDI-DIs/EUDAMED IDs) and/or of Systems or
Procedure Packs will appear if any are found (otherwise "No data available" will be
displayed):

4. Click on the UDI-DI/EUDAMED ID row of your choice to see the details:

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8.1 Search & View historical versions of

Devices, Systems and Procedure Packs
1. Follow the steps in Search & View Devices, Systems and/or Procedure Packs [74] to
search and view a device or system or procedure pack.

2. Inside the search page, select the filters for your search, activate the option to include
historical versions (just above the “Search” button) and click on “Search”:

3. The list generated below will include the desired current UDI-DI as well as its
versions. Click on the version you wish to view:

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8.2 Download Devices or Systems or

Procedure Packs data in a structured
format (XML)

NOTE
You can only manually bulk download in XML your own device or system/procedure
pack data if you are a manufacturer or a system/procedure pack producer.

1. Follow the steps in Search & View Devices, Systems and/or Procedure Packs [74]
to search and view a device or a system or procedure pack. On the search page,
activate the top filter (Only enable search filters available for bulk XML download)
so that you can only enter search criteria that can be used for search results that can
be downloaded in an XML format, and enter your search criteria:

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2. Enter the search criteria of your choice, and click on “Search”:

3. Click on “Generate XML file”:

NOTE
Only what is shown on the result list will be included in the generated file and not
all the results of your search (in case there are more pages of results).

4. A pop-up window will ask you to confirm your action:

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5. The system will inform you that the action has been successful. Click on “Go to
Download Management” under the question “What do you want to do now?”:

6. You can download the generated XML file by clicking on it under the “Download”
column:

8.3 View historical versions for Basic UDI-

DI/EUDAMED DI, UDI-DI/EUDAMED ID and
associated entities
1. Follow the steps in Search & View historical versions of Devices, System and/or
Procedure Packs [76] to view the details of a Device or System or Procedure Pack.

2. Once inside the details of the chosen UDI-DI, go to the section in which you wish to
view old versions (e.g. Basic UDI-DI/ EUDAMED DI, UDI-DI/EUDAMED ID, Market
Information, Product Designer or Container Package) and click on “See version
history”:

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3. You will see, if any, a list of all old versions for the selected entity, e.g. version history
of the Basic UDI-DI):

4. Click on the version you wish to view to access its details:

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5. Inside a version, click on the links on the top right corner to browse through the
different versions (all versions, previous, next):

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9 Annex 1 – Device
Certificate Information
This Annex presents the cases in which the Certificate information needs to be provided
when registering a Regulation Device and the Certificate type needed to be provided
based on the properties of the Device.

Colour-code description.

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10 Annex 2 – Legacy
Device Certificate Types
Current Annex presents the Certificate types that can be used when registering a Legacy
Device.

Certificate types are depending on the Applicable legislation of the Device.

Annex 2 – Legacy Device Certificate Types 84