EUDAMED user guide

UDI Devices

Playground v 3.11.0
2025
 EUDAMED user guide

Table of Contents
1. Introduction ............................................................................. 1
2. Getting started ........................................................................ 3
3. Registering Regulation Devices .............................................. 4
3.1. Registration of a Basic UDI-DI together with a UDI-DI
of a Regulation Device .......................................................... 5
3.1.1. Step 1: Basic UDI-DI identification information ..... 6
3.1.2. Step 2: Certificate information (if applicable) ........ 9
3.1.3. Step 3: UDI-DI identification information ............. 11
3.1.4. Step 4: UDI-DI characteristics ............................. 15
3.1.5. Step 5: Device information .................................. 18
3.1.6. Step 6: Container package details ...................... 23
3.2. Registration of a UDI-DI for an existing Basic UDI-DI
of a Regulation Device ........................................................ 26
4. Registering System or Procedure Packs (SPP) ................... 29
4.1. Registration of a Basic UDI-DI together with a UDI-DI
for a System or Procedure Pack ......................................... 29
4.1.1. Step 1: Basic UDI-DI main information ............... 29
4.1.2. Step 2: Basic UDI-DI information ........................ 31
4.1.3. Step 3: UDI-DI identification information ............. 32
4.1.4. Step 4: UDI-DI characteristics ............................. 34
4.1.5. Step 5: Container package details ...................... 36
4.2. Registration of a UDI-DI for an existing Basic UDI-DI
of a System or Procedure Pack .......................................... 38
4.2.1. Step 1: UDI-DI identification information ............. 39
4.2.2. Step 2: UDI-DI characteristics ............................. 41
4.2.3. Step 3: Container package details ...................... 41
5. Manage your own device information ................................... 42
5.1. Manage your device Basic UDI-DI/EUDAMED DI
details .................................................................................. 42
5.1.1. Delete a draft Basic UDI-DI/EUDAMED DI ......... 43
5.1.2. Update (create new version) for Basic UDI-DI/
EUDAMED DI ................................................................ 44
5.1.3. View historical versions for Basic UDI-DI/
EUDAMED DI ................................................................ 45
 EUDAMED user guide

5.2. Manage your device UDI-DI/EUDAMED ID details ...... 46

5.2.1. Delete a draft UDI-DI/EUDAMED ID ................... 49
5.2.2. View details of a registered UDI-DI/EUDAMED
ID ................................................................................... 49
5.2.3. Update (create a new version) for UDI-DI/
EUDAMED ID ................................................................ 57
5.2.4. Update (create new version) for Product original
manufacturer ................................................................. 62
5.2.5. Update (create new version) for Market
Information .................................................................... 64
5.2.6. Update (create new version) for Container
Packages ...................................................................... 65
5.2.7. Discard registered UDI-DIs/EUDAMED IDs (and
their Basic UDI-DI/EUDAMED DI) ................................. 70
5.2.8. Link a registered Regulation Device to a
registered Legacy Device .............................................. 71
5.2.9. Delete the link between a Regulation Device
and a Legacy Device ..................................................... 74
5.2.10. View historical versions of UDI-DI/EUDAMED
ID and associated entities ............................................. 75
6. Manage your own System or Procedure Pack (SPP)
information ................................................................................ 77
6.1. Manage your SPP Basic UDI-DI details ....................... 77
6.1.1. Delete a draft Basic UDI-DI ................................. 78
6.1.2. Update (create new version) for Basic UDI-DI .... 79
6.1.3. View historical version for Basic UDI-DI .............. 81
6.2. Manage your SPP UDI-DI details ................................ 82
6.2.1. Delete a draft UDI-DI ........................................... 83
6.2.2. Update (create new version) for UDI-DI .............. 84
6.2.3. Update (create new version) for Container
Packages ...................................................................... 86
6.2.4. Discard SPP registered UDI-DIs ......................... 88
6.2.5. View SPP historical versions for UDI-DI and
associated entities ......................................................... 90
7. Search & View Devices, Systems and/or Procedure Packs . 91
 EUDAMED user guide

7.1. Search & View sub-statuses of Devices, Systems

and/or Procedure Packs ..................................................... 93
7.2. Search & View historical versions of Devices,
Systems and Procedure Packs ........................................... 95
7.3. Download Devices or Systems or Procedure Packs
data in a structured format (XML) ....................................... 97
7.4. View historical versions for Basic UDI-DI/EUDAMED
DI, UDI-DI/EUDAMED ID and associated entities .............. 99
8. Annex – device certificate information ................................ 103
 EUDAMED user guide

1 Introduction
Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro
diagnostic 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

WARNING
EUDAMED does not contain all constraints defined in the MDR/IVDR, guidance and
good practices, and therefore, it is not because something is possible in EUDAMED
that it is necessarily allowed.

VIDEO: What is a UDI?

INFOGRAPHIC: Basic UDI-DI/UDI-ID concept

1Fora wider understanding on how to use the platform visit the EUDAMED Information Centre. For information
specific to UDI, visit the UDI Helpdesk.

Introduction 1
 EUDAMED user guide

Introduction 2
 EUDAMED user guide

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 Economic
Operators user guide.

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 profile 2
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.

NOTE
See the Economic Operators user guide, Section Upgrading your user profile for further
information on how to upgrade your profile from Viewer to Proposer or Confirmer.

IMPORTANT
A Local Actor Administrator (LAA)/Local User Administrator (LUA) of your manufacturer
must approve your user access request (If you don't have a second user with LAA/LUA
profile, please refer to the Economic Operators user guide, Section Requesting access
as a second LAA user to an existing registered actor).

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

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

Getting started 3
 EUDAMED user guide

3 Registering Regulation
Devices
VIDEO: 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-DI without a UDI-DI.

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

INFOGRAPHIC: UDI registration for regulation devices

Registering Regulation Devices 4

 EUDAMED user guide

3.1 Registration of a Basic UDI-DI

together with a UDI-DI of a Regulation
Device
INFOGRAPHIC: Basic UDI-DI/UDI-ID concept

Registering Regulation Devices 5

 EUDAMED user guide

3.1.1 Step 1: Basic UDI-DI identification information

VIDEO: UDI and medical software devices

1. Click on Register a new Basic UDI-DI:

2. Next, enter the Basic UDI-DI information. Select the applicable regulation.

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

Registering Regulation Devices 6

 EUDAMED user guide

Depending on the regulation 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 Software3 (See video above):

3For more information, visit the EUDAMED Information Centre, or the UDI Assignment to Medical Device
Software webpage.

Registering Regulation Devices 7

 EUDAMED user guide

NOTE
If one of the following Special Device types is selected, the Master UDI-DI applies:

• Standard soft contact lenses

• Standard Rigid Gas Permeable (RGP) contact lenses

• Made to order soft contact lenses

• Made to order Rigid Gas Permeable (RGP) contact lenses.

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.

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.

Registering Regulation Devices 8

 EUDAMED user guide

6. Select Yes or No if Device model is applicable. If you selected No, 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 later, or on Save &
Next to save it as a draft and continue directly with the following steps:

3.1.2 Step 2: Certificate information (if applicable)

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

For 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

Registering Regulation Devices 9

 EUDAMED user guide

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 – Device Certificate Information [103] 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).

Registering Regulation Devices 10

 EUDAMED user guide

3.1.3 Step 3: UDI-DI identification information

VIDEO: UDI carrier and display formats

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 shorter 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)

Registering Regulation Devices 11

 EUDAMED user guide

NOTE
When registering a Master UDI-DI code, a specific format validation algorithm is
applied when the issuing entity is GS1:

• For Standard soft contact lenses and Standard Rigid Gas Permeable (RGP)
contact lenses the system applies the GMN format validation algorithm.

• For Made-to-order soft contact lenses and Made-to-order Rigid Gas

Permeable (RGP) contact lenses the system applies the GTIN UDI-DI format
validation algorithm.

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 (as specified on the device label) and select its
related language (select All languages if not language dependent):

5. Enter the Reference/Catalogue number:

Registering Regulation Devices 12

 EUDAMED user guide

NOTE
For a Master UDI-DI, if there are multiple Reference/Catalogue numbers, you may
enter 'many' as the value:

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.

NOTE
Direct Marking UDI-DI is not applicable for a Master UDI-DI. The field is set to No
and it is greyed out.

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 (UoU DI) can be used for different UDI-DIs in case the
same device has different root packaging (each one having a different UDI-DI).

NOTE
The Unit of Use DI and its Issuing Entity fields are not applicable for a Master
UDI-DI. They are set to No and they are greyed out.

Registering Regulation Devices 13

 EUDAMED user guide

8. If the base quantity is less than two, then no Unit of Use DI (UoU DI) is provided:

NOTE
For a Master UDI-DI, please indicate the maximum number of devices for the
Quantity of Device:

9. Select the Type of UDI-PI.

10. Enter any additional pertinent information about the device, select the language in
which the additional information is provided and enter a URL (web address) for
additional information online if applicable:

11. Specify the UDI-DI status in selecting whether it is On the EU market, Not intended
for the EU market or No longer placed on the EU market and click on Save or Save &
Next:

Registering Regulation Devices 14

 EUDAMED user guide

3.1.4 Step 4: UDI-DI characteristics

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

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 of description. 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 provided in the same languages.

You must provide one of the following precision types:

• Range – requires 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 dimensions, but only
one dimension for a given type.

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

When the device is not labelled single use you must provide the number of reuses if
applicable:

Registering Regulation Devices 15

 EUDAMED user guide

• If the Maximum number of reuses is not applicable, then the device is considered
as non-single use Device and it 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)

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

NOTE
Containing latex is only for MDR, not applicable for IVDR.

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

Registering Regulation Devices 16

 EUDAMED user guide

5. Fill in the Storage/handling conditions section:

NOTE
For Storage/handling conditions type Other, users must enter the Description of
the Storage/handling condition type and the description's language.

6. Fill in Critical warnings or contra-indications, and click Save or Save & Next:

Registering Regulation Devices 17

 EUDAMED user guide

NOTE
For Critical warning or contra-indications type Other, users must enter the
Description of the Critical warning or contra-indications type and the description's
language.

3.1.5 Step 5: Device information

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

2. If you select Yes for the Intended purpose, select the relevant purpose(s):

NOTE
When registering a Master UDI-DI for contact lenses, if you select Yes for Annex
XVI, the list of possible choices will not be displayed, as it is already predefined.

3. Select Yes or No if the device was designed and manufactured by another legal or
natural person.
If Yes, there are two ways to find the Product original manufacturer of the device:
• Check the box I know the Actor ID/SRN, enter the Actor ID/SRN or name of the
Product original manufacturer of the device and click Check registry:

Registering Regulation Devices 18

 EUDAMED user guide

NOTE
Check the box I know theActor ID/SRN in order to search for an existing
registered Manufacturer Actor either by SRN or by name.

Select the Actor from the list:

• Enter the name of the Product original manufacturer organisation name and click
on Check registry:

Registering Regulation Devices 19

 EUDAMED user guide

Select the Organisation name from the list:

If the Organisation name is not on the list, click on Enter data manually and fill
in the required fields with the details on the Product original manufacturer of the
device:

Registering Regulation Devices 20

 EUDAMED user guide

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

5. When registering under MDR, select Yes or No to fill information on tissues and cells,
and information on substances:

Registering Regulation Devices 21

 EUDAMED user guide

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

For IVDR, select Yes or No to fill information on tissues and cells and specify if the
device is new:

Registering Regulation Devices 22

 EUDAMED user guide

NOTE
A device shall be considered new if:

• 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.

• 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.

6. Choose a Member State in the drop-down list where the device is or has been first
placed on the EU market, and click Save or Save & Next:

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

VIDEO: UDI carrier placing

Registering Regulation Devices 23

 EUDAMED user guide

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

Each package level requires a unique UDI-DI assignment.

Start by registering the container package associated with the root UDI-DI (also
known as the primary UDI-DI). You may add multiple levels and container packages.
Input the Issuing Entity, UDI-DI code for the package, Quantity per package, select
the Package status and then click Save:

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

NOTE
If the status of the device for this container package is either No longer placed on
the EU Market or Not intended for the EU Market, the Package status options are
greyed out and any container package added to this device will automatically have
the same Package status as the device.

Registering Regulation Devices 24

 EUDAMED user guide

NOTE
When registering a Master UDI-DI code, a specific format validation algorithm is
applied when the issuing entity is GS1:

• For Standard soft contact lenses and Standard Rigid Gas Permeable (RGP)
contact lenses the system applies the GMN format validation algorithm.

• For Made-to-order soft contact lenses and Made-to-order Rigid Gas

Permeable (RGP) contact lenses the system applies the GTIN format
validation algorithm.

2. Select the generated information and click on Submit:

3. Confirm your submission in the pop-up window:

4. The screen will display a success message:

Registering Regulation Devices 25

 EUDAMED user guide

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 confirmation from the
Notified Body (Basic UDI-DI and UDI-DI is publicly available in the EUDAMED
public website);

• Submitted, if the Basic UDI-DI data requires confirmation from the Notified
Body (Basic UDI-DI and UDI-DI is 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:

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

Registering Regulation Devices 26

 EUDAMED user guide

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 wish to add a new UDI-DI. Click
on the three dots on the right and click on Add a UDI-DI to this Basic UDI-DI / Add a
Master UDI-DI to this Basic UDI-DI:

4. Complete the steps required for the registration of a UDI-DI for an existing Basic UDI-
DI (Step 3: UDI-DI identification information [11], Step 4: UDI-DI Characteristics [15],
Step 5: Device information [18], Step 6: Container Package Details [23]):

Registering Regulation Devices 27

 EUDAMED user guide

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.

Registering Regulation Devices 28

 EUDAMED user guide

4 Registering System or
Procedure Packs (SPP)
4.1 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.

4.1.1 Step 1: Basic UDI-DI main information

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

2. Next, specify the Issuing Entity and the Basic UDI-DI code:

Registering System or Procedure Packs (SPP) 29

 EUDAMED user guide

NOTE
Only 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:

Registering System or Procedure Packs (SPP) 30

 EUDAMED user guide

4.1.2 Step 2: Basic UDI-DI information

Enter the Basic UDI-DI information:

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

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

Registering System or Procedure Packs (SPP) 31

 EUDAMED user guide

If you add the indication in multiple languages, click on Add another indication of
medical purpose and select its language.
Select Yes or No if Device model is applicable and, if so, 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, or click on Save & Next to save it
as a draft and continue to the next steps:

4.1.3 Step 3: UDI-DI identification information

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

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

Registering System or Procedure Packs (SPP) 32

 EUDAMED user guide

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 shorter 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. Enter the Secondary UDI-DI from a different Issuing Entity to the UDI-DI if applicable:

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

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):

Registering System or Procedure Packs (SPP) 33

 EUDAMED user guide

5. Enter the Reference/Catalogue number.

6. Select the Type of UDI-PI.

7. Enter any additional pertinent information about the System or Procedure Pack,
select the language of the additional information and enter a URL (web address)
for additional information online, if applicable:

8. Specify the UDI-DI status in selecting whether it is On the EU market, Not intended
for the EU market or No longer placed on the EU market and click on Save or Save &
Next:

4.1.4 Step 4: UDI-DI characteristics

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

Registering System or Procedure Packs (SPP) 34

 EUDAMED user guide

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.

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

Registering System or Procedure Packs (SPP) 35

 EUDAMED user guide

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 description's language.

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

4.1.5 Step 5: Container package details

VIDEO: UDI and Systems and Procedure Packs

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

Registering System or Procedure Packs (SPP) 36

 EUDAMED user guide

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, select the Package status and click on Save:

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

NOTE
If the status of the device for this container package is either No longer placed on
the EU Market or Not intended for the EU Market, the Package status options are
greyed out and any container package added to this device will automatically have
the same Package status as the device.

2. Select the generated information and click on Submit:

Registering System or Procedure Packs (SPP) 37

 EUDAMED user guide

3. On the pop-up window, click on Submit my Request:

Upon submission, a success message will be displayed on the screen:

4.2 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:

Registering System or Procedure Packs (SPP) 38

 EUDAMED user guide

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 filters:

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:

4.2.1 Step 1: UDI-DI identification information

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

Registering System or Procedure Packs (SPP) 39

 EUDAMED user guide

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

Registering System or Procedure Packs (SPP) 40

 EUDAMED user guide

4.2.2 Step 2: UDI-DI characteristics

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

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

4.2.3 Step 3: Container package details

To complete this step, please consult Container Package Details [36] of this guide.

Registering System or Procedure Packs (SPP) 41

 EUDAMED user guide

5 Manage your own device

information
5.1 Manage your device Basic UDI-DI/
EUDAMED DI details
1. On the dashboard, click on Manage your Basic UDI-DI/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.

Manage your own device information 42

 EUDAMED user guide

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:

5.1.1 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. Inside the View details page of the desired 1st draft, click on Delete:

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

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

Manage your own device information 43

 EUDAMED user guide

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.

5.1.2 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
versionCreate new version on the top right corner:

2. Update the desired details:

Manage your own device information 44

 EUDAMED user guide

3. To complete the action:

• Click on Save to save to your registration as a draft and continue later.

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

Alternatively, click on Cancel to cancel the update.

5.1.3 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:

Manage your own device information 45

 EUDAMED user guide

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

5.2 Manage your device UDI-DI/EUDAMED

ID details
1. On the EUDAMED dashboard, click on Manage your device details:

Manage your own device information 46

 EUDAMED user guide

2. You will see a list:

Manage your own device information 47

 EUDAMED user guide

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

3. Click on the three dots 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:

Manage your own device information 48

 EUDAMED user guide

5.2.1 Delete a draft UDI-DI/EUDAMED ID

Follow the steps in Manage your device UDI-DI/EUDAMED ID details [46] 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.

5.2.2 View details of a registered UDI-DI/EUDAMED ID

1. On the dashboard, click on Manage your device details:

Manage your own device information 49

 EUDAMED user guide

2. Select the option Registered in the State field and click on Apply filters:

3. A list of devices will be displayed. Click on View data under the three dots of the
desired entry:

Manage your own device information 50

 EUDAMED user guide

4. You will see a summary of your device details, divided into the following subsections:
• UDI-DI details:

Manage your own device information 51

 EUDAMED user guide

NOTE
Master UDI-DI Details section for a registered Master UDI-DI:

Manage your own device information 52

 EUDAMED user guide

The UDI-DI/Device sub-status subsection will become visible under the UDI-DI/
Device status subsection once a final Field Safety Notice (FSN – Vigilance module)
has been registered for the selected UDI-DI/EUDAMED ID referenced in the
corresponding Field Safety Corrective Action (FSCA – Vigilance module).

Manage your own device information 53

 EUDAMED user guide

NOTE
The sub-status of the device will be set to Field safety corrective action initiated
if any of the following manufacturer actions are selected in the corresponding
FSCA:

• IFU or labeling change

• Software Upgrade

• On-site modification/inspection by

• Customer information only

• Other

The sub-status of the device will be set to Recalled if any of the following
manufacturer actions are selected in the corresponding FSCA:

• Product Removal - Partial Recall (Lot/Batch/Model)

• Product Removal - Full Recall

Manage your own device information 54

 EUDAMED user guide

NOTE
When the FSCA status transitions to Action completed, the system will remove
the corresponding device sub-status:

If the FSCA status referencing the device transitions to In progress, the sub-
status will be displayed again.

Manage your own device information 55

 EUDAMED user guide

• Product original manufacturer:

• Market Information:

• Container Package Information:

Manage your own device information 56

 EUDAMED user guide

NOTE
Container Package Information section for a registered Master UDI-DI:

5.2.3 Update (create a new version) for UDI-DI/

EUDAMED ID
VIDEO: UDI assignment and updates

Follow the steps in section Manage your device UDI-DI/EUDAMED ID details [46] 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:

Manage your own device information 57

 EUDAMED user guide

Manage your own device information 58

 EUDAMED user guide

Manage your own device information 59

 EUDAMED user guide

NOTE
The available options for the UDI-DI status depend on the initial status of the
device.

• If the initial UDI-DI status of the device is either On the EU market or No longer
placed on the EU market, when updating the UDI-DI status of the device, you
can select either the On the EU market or the No longer placed on the EU
market status.

• If the initial UDI-DI status of the device is Not intended for the EU market, when
updating the UDI-DI status of the device you can only select the On the EU
market status.

NOTE
In the UDI-DI status field, if you select the No longer placed on the EU market
status, the Market information will no longer be displayed and all container
packages linked to this device will automatically be updated to the same status
as the device.

Otherwise, if you select the On the EU market status, you must select a Member
State in the drop-down list where the device is or has been first placed on the EU
market and the Member State(s) where the device is or is to be made available.
You must also manually update all container packages linked to this device.

Manage your own device information 60

 EUDAMED user guide

TIP
Master UDI-DI update variation

When creating a new version of a Master UDI-DI, the Quantity of device field is
editable, whereas for the UDI-DI, it is not.

2. To finish the action you have two options:

• Save to save the updated details without submitting the new version.

• Submit new version, if you wish to finalise the update.

Once you have submitted the new version, click on Confirm in the pop-up window to
finalise the update:

Manage your own device information 61

 EUDAMED user guide

5.2.4 Update (create new version) for Product original

manufacturer
The Product original manufacturer information can be updated independently of other data
in a device UDI-DI record.

NOTE
Product original manufacturer information can be updated if it was initially provided with
details of an Organisation that is not a registered Actor with an Actor ID/SRN.

It cannot be updated if it was initially marked as Not applicable, or if it was specified

with an Actor ID/SRN.

Follow the steps in section Manage your device UDI-DI/EUDAMED ID details [46] to view
a UDI-DI/EUDAMED ID.

1. Once inside the details of the selected UDI-DI, click on Product original
manufacturer from the list on the left (or scroll down to Product original
manufacturer):

2. Click on Update to access the Product original manufacturer page:

• You can either update the details on Product original manufacturer:

Manage your own device information 62

 EUDAMED user guide

Or

• You can update the Product original manufacturer to an actor that is already
registered in EUDAMED.
Check the box I know the Actor ID/SRN, enter the Actor ID/SRNor name of the
Product original manufacturer of the device and click on Check registry:

In the pop-up window, select the Product original manufacturer from the list:

Manage your own device information 63

 EUDAMED user guide

3. 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 original manufacturer
information.

NOTE
Once you update the Product original manufacturer to an actor that is already
registered in EUDAMED, you will not be able to perform any further update to the
Product original manufacturer via the UDI/Devices module.

5.2.5 Update (create new version) for Market

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

Follow the steps in section Manage your device UDI-DI/EUDAMED ID details [46] to view
a UDI-DI/EUDAMED ID.

1. Once inside the details of the selected UDI-DI, click on Market Information from the
list on the left (or scroll down to Market Information):

2. Click on Update countries:

Manage your own device information 64

 EUDAMED user guide

3. Update the relevant fields under Market Information:

4. Click Submit to finalise the update. You will be able to see the updated version of
Market Information:

5.2.6 Update (create new version) for Container

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

Follow the steps in section Manage your device UDI-DI/EUDAMED ID details [46] to view
a UDI-DI/EUDAMED ID.

Manage your own device information 65

 EUDAMED user guide

1. 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):

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

Manage your own device information 66

 EUDAMED user guide

Manage your own device information 67

 EUDAMED user guide

NOTE
Only if the status of the selected UDI-DI is On the EU market, will you be able to
update the status of the container package. Otherwise, the options will be greyed
out and you will not be able to update the status of the container package for the
selected UDI-DI.

3. Click on Submit to finalise the container package update:

Manage your own device information 68

 EUDAMED user guide

TIP
Master UDI-DI update variation

When creating a new version of a Master UDI-DI container package, the Maximum
quantity per package field is editable, whereas for the UDI-DI container package, it
is not:

Manage your own device information 69

 EUDAMED user guide

5.2.7 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.

Follow the steps in section Manage your device UDI-DI/EUDAMED ID details [46] to view
a registered UDI-DI/EUDAMED ID.

1. Once inside the details page of the selected UDI-DI, click on Discard at the top right
corner:

2. Confirm your intention to discard the registered UDI-DI:

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

Manage your own device information 70

 EUDAMED user guide

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

5.2.8 Link a registered Regulation Device to a registered

Legacy Device
Follow the steps in Manage your device UDI-DI/EUDAMED ID details [46] and select the
Registered option in the State field to manually link a registered regulation device to a
registered legacy device.

1. Once inside the relevant registered regulation device click on Link to legacy device:

2. The page next contains details on the selected registered regulation device and a list
with all possible compatible legacy devices to be linked to:

Manage your own device information 71

 EUDAMED user guide

3. You can either select the desired legacy device using the search box or you can
select it from the list. Select the device and click on Select this device:

4. Click on Confirm in the pop-up window:

Manage your own device information 72

 EUDAMED user guide

NOTE
If some characteristics don't match, then you will not be able to link the registered
regulation device to the selected legacy device:

5. The system will redirect you back to the regulation device's page:

6. You can view details on the linked legacy device by selecting the link to the legacy
device under the Related Device section:

Manage your own device information 73

 EUDAMED user guide

7. The legacy device's page will appear. You can view the linked regulation device under
the Related Device section:

NOTE
See the Legacy Devices - user guide for further details on Legacy Devices.

5.2.9 Delete the link between a Regulation Device and a

Legacy Device
Follow the steps in Manage your device UDI-DI/EUDAMED ID details [46] and select the
Registered option in the State field.

1. Once inside the relevant registered regulation device click on Remove the link to this
device under the Related Device section:

Manage your own device information 74

 EUDAMED user guide

2. Click on Confirm on the pop-up window:

NOTE
See the Legacy Devices - user guide for further details on Legacy Devices.

5.2.10 View historical versions of UDI-DI/EUDAMED ID

and associated entities
Follow the steps in section Manage your device UDI-DI/EUDAMED ID details [46] to view
a UDI-DI/EUDAMED ID.

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

Manage your own device information 75

 EUDAMED user guide

2. In the list of versions displayed, click on the version you wish to access:

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

Manage your own device information 76

 EUDAMED user guide

6 Manage your own System

or Procedure Pack (SPP)
information
6.1 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:

Manage your own System or Procedure Pack (SPP) information 77

 EUDAMED user guide

3. A details summary of your system or procedure pack is displayed:

6.1.1 Delete a draft Basic UDI-DI

Follow the steps in section Manage your SPP Basic UDI-DI details [77] to view a Draft
Basic UDI-DI:

1. Once inside the draft, click on Delete:

Manage your own System or Procedure Pack (SPP) information 78

 EUDAMED user guide

2. Confirm the deletion on the pop-up window:

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

Follow the steps in section Manage your SPP Basic UDI-DI details [77] to view a Basic
UDI-DI:

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

Manage your own System or Procedure Pack (SPP) information 79

 EUDAMED user guide

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:

• Click on Save to save the updated details without submitting the new version.

• Click on Submit new version if you wish to submit it.

Alternatively, 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:

Manage your own System or Procedure Pack (SPP) information 80

 EUDAMED user guide

6.1.3 View historical version for Basic UDI-DI

Follow the steps in section Manage your SPP Basic UDI-DI details [77] to view a Basic
UDI-DI.

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

To return, click Go back to the current version:

Manage your own System or Procedure Pack (SPP) information 81

 EUDAMED user guide

6.2 Manage your SPP UDI-DI details

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

2. To find the desired UDI-DI, click on the Filter button and choose the right parameters:

Manage your own System or Procedure Pack (SPP) information 82

 EUDAMED user guide

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. A summary of the details concerning your chosen SPP UDI-DI will be displayed:

6.2.1 Delete a draft UDI-DI

Follow the steps in section Manage your SPP UDI-DI details [82] to view a draft UDI-DI.

Manage your own System or Procedure Pack (SPP) information 83

 EUDAMED user guide

1. Once inside the draft, click on Delete:

2. Confirm the deletion in the pop-up window:

6.2.2 Update (create new version) for UDI-DI

Follow the steps in Manage your SPP UDI-DI details [82] to view a UDI-DI:

Manage your own System or Procedure Pack (SPP) information 84

 EUDAMED user guide

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

2. Update the necessary details.

Manage your own System or Procedure Pack (SPP) information 85

 EUDAMED user guide

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

3. To finish the action you have two options:

• Click on Save to save the updated details without submitting the new version.

• Click on Submit new version, if you wish to submit it.

Otherwise press Cancel to cancel the update.

6.2.3 Update (create new version) for Container

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

Follow the steps in section Manage your SPP UDI-DI details [82] to view a specific
UDI-DI:

Manage your own System or Procedure Pack (SPP) information 86

 EUDAMED user guide

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

2. Click on Create new version in the Container Package section:

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

Manage your own System or Procedure Pack (SPP) information 87

 EUDAMED user guide

4. Insert the package details in the pop-up window and click on Save:

6.2.4 Discard SPP registered UDI-DIs

Follow the steps in section Manage your SPP UDI-DI details [82] to view a chosen
Registered UDI-DI:

Manage your own System or Procedure Pack (SPP) information 88

 EUDAMED user guide

1. Once inside the details page of the chosen UDI-DI, click on Discard at the top right
corner:

2. Confirm your intention to discard the record in the pop-up window:

Manage your own System or Procedure Pack (SPP) information 89

 EUDAMED user guide

6.2.5 View SPP historical versions for UDI-DI and

associated entities
Follow the steps in section Manage your SPP UDI-DI details [82] to view a UDI-DI for the
SPP.

1. Once inside the details of the chosen UDI-DI, click on See version history at the top
of the table to view a list of all past versions:

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

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

Manage your own System or Procedure Pack (SPP) information 90

 EUDAMED user guide

7 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 on the dashboard called Search & View:

2. You can use the filters to search for Devices, Systems and/or Procedure Packs
(SPP) registered in EUDAMED, or, in the case of Competent Authorities and Notified
Bodies, those submitted or discarded:

Search & View Devices, Systems and/or Procedure Packs 91

 EUDAMED user guide

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 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:

Search & View Devices, Systems and/or Procedure Packs 92

 EUDAMED user guide

7.1 Search & View sub-statuses of

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:

Search & View Devices, Systems and/or Procedure Packs 93

 EUDAMED user guide

2. Select the sub-status in the dropdown list and click Search:

3. A list of Devices (UDI-DIs/EUDAMED IDs) and/or Systems or Procedure Packs will

appear if any are found:

Search & View Devices, Systems and/or Procedure Packs 94

 EUDAMED user guide

4. Click on the UDI-DI/EUDAMED ID row of your choice to see the details. Scroll down
to the Status of the UDI-DI/Device subsection.
Read the View details of a registered UDI-DI/EUDAMED ID [49] section for more
details on the sub-status of a device.

7.2 Search & View historical versions of

Devices, Systems and Procedure Packs
Follow the steps in Search & View Devices, Systems and/or Procedure Packs [91] to
search and view a device or system or procedure pack.

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

Search & View Devices, Systems and/or Procedure Packs 95

 EUDAMED user guide

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

Search & View Devices, Systems and/or Procedure Packs 96

 EUDAMED user guide

7.3 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.

Follow the steps in Search & View Devices, Systems and/or Procedure Packs [91] to
search and view a device or a system or procedure pack.

1. On the search page, activate the top filter (Only enable search filters available for
bulk XML download) and enter your search criteria.
Enter the search criteria of your choice, and click on Search:

2. Click on Generate XML file:

Search & View Devices, Systems and/or Procedure Packs 97

 EUDAMED user guide

NOTE
Only what is shown on the result list will be included in the generated file and not
all the results of your search. If the search yields multiple pages of results, you will
need to download an XML file for each page to capture all the data.

3. Confirm your action in the pop-up window:

4. The system will display a success message. Click on Go to Download Management

under the question What do you want to do now?:

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

Search & View Devices, Systems and/or Procedure Packs 98

 EUDAMED user guide

7.4 View historical versions for Basic UDI-

DI/EUDAMED DI, UDI-DI/EUDAMED ID and
associated entities
Follow the steps in Search & View historical versions of Devices, System and/or
Procedure Packs [95] to view the details of a Device or System or Procedure Pack.

1. 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 original manufacturer or Container Package) and click on See
version history:

Search & View Devices, Systems and/or Procedure Packs 99

 EUDAMED user guide

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

Search & View Devices, Systems and/or Procedure Packs 100

 EUDAMED user guide

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

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

Search & View Devices, Systems and/or Procedure Packs 101

 EUDAMED user guide

Search & View Devices, Systems and/or Procedure Packs 102

 EUDAMED user guide

8 Annex – 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.

Annex – device certificate information 103