Guide to Using

EUDAMED
UDI Device Management for Manufacturers

Last Update: 16/07/2019

 Contents

Introduction 1

Managing UDI Devices 2

Basic Concepts .............................................................................................................. 3

Registering Devices ....................................................................................................... 4
STEP 1 Entering Basic UDI-DI Identification Information ............................................ 4
STEP 2 Entering UDI-DI Identification Information ...................................................... 9
STEP 3 Entering Container Package Information ...................................................... 15

Index 17

EUDAMED User's Guide – UDI Device Management Contents  i

Introduction
EUDAMED is the IT system developed by the European Commission to implement
Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on
in vitro diagnosis medical devices (IVDR).

EUDAMED is structured around 6 interconnected modules and has a public site. The 6
modules include:
 Actors registration
 UDI database and registration of devices
 Certificates and Notified Bodies
 Clinical Investigation and performance studies
 Vigilance and post-market surveillance
 Market Surveillance

This manual covers the second module i.e. UDI database and registration of devices. It is
intended for Manufacturers who are supposed to have validly registered in EUDAMED (i.e.
obtained an 'SRN' (Single Registration Number)).

Further guidance
Please be aware that this manual does not provide guidance, clarifications or recommendations
for complying with the legislation. For more specific information regarding the correct
interpretation of the medical device legislation, please refer to the following websites:
 The web section about Medical Devices on the European Commission's Directorate-
General for Internal Market, Industry, Entrepreneurship and SMEs website:
http://ec.europa.eu/growth/sectors/medical-devices_en
 The Medical Devices Coordination Group (MDCG) MDCG Guidance web section on the
European Commission's Directorate-General for Internal Market, Industry,
Entrepreneurship and SMEs website:
http://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en
 The online documents available on the CAMD (Competent Authorities for Medical Devices
CAMD) website:
https://www.camd-europe.eu/regulatory/medical-devices-regulation-vitro-diagnostics-
regulation-mdr-ivdr-roadmap/

EUDAMED User's Guide – UDI Device Management Introduction  1

Managing UDI Devices
IN THIS SECTION
Basic Concepts 3
Registering Devices 4

The new MDR 2017/745 and IVDR 2017/746 EU regulations require that manufacturers
of medical devices submit the UDI/Device information of all devices/products that they
place on the market.

The Device module of EUDAMED is used for this purpose.

A step-by-step wizard will guide you through the device registration process. Please
make sure that you understand all concepts and have all information at hand before
starting to register a new UDI/device.

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 EUDAMED User's Guide – UDI Device Management

Basic Concepts

The UDI (Unique Device Identification) system is one of the main novelties brought by the
MDR 2017/745 and IVDR 2017/746 EU regulations. It is intended to improve the
traceability of medical devices throughout the supply chain by connecting all the
information about every single medical device.
Upon production of a medical device, manufacturers will have to register their devices in
EUDAMED. Every UDI device will be uniquely identified and characterised by 2 main
device identifiers i.e. a Basic UDI-Di and a UDI-DI.

In addition to these, for devices with a higher level of packaging, a Package UDI-DI will
be used if applicable, to identify a package in a unique way.

 BASIC UDI-DI
In EUDAMED, the Basic UDI Device Identifier, or 'Basic UDI-DI', is the primary
identifier of a device model/family/group (e.g. insulin syringes, hip prosthesis, etc.) in
a manufacturer's portfolio, regardless of any specific any variations in minor
characteristics or packaging levels. All devices with the same Basic UDI-DI shall
share the same core characteristics, like intended purpose, risk class, essential
design and manufacturing characteristics. The Basic UDI-DI information to be
provided for a device in EUDAMED includes this core information, plus a unique
Basic UDI-DI code issued by an officially designated issuing entity. It is not
referenced on labels, only in some documents like Certificates, Declarations of
Conformity and Technical documentation

 UDI-DI
The UDI is the main identifier of a medical device used on its label. It identifies the
specific device within a given product family. The UDI-DI (Device Identifier is a
unique code created through/received from an officially designated issuing entity.

(PACKAGE UDI-DI)
If applicable, each device may have an additional, higher-level UDI-DI assigned to its
higher package. Package UDI-DIs are used to identify each package configuration,
with its quantities of items at each package level.

While a UDI-DI can have only one Basic UDI-DI, multiple UDI-DIs can be referencing
the same Basic UDI-DI to reflect the different devices that a manufacturer has under
the same intended purpose and essential design and manufacturing characteristics.

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 EUDAMED User's Guide – UDI Device Management

Registering Devices

Before you start entering details of a device in EUDAMED, please make sure that you
have all requested information at hand, including the Basic UDI-DI and UDI-DI codes that
you have assigned from the list of codes that were allocated by the selected UDI issuing
entity/entities.

STEP 1 Entering Basic UDI-DI Identification Information

 To enter Basic UDI-DI
1. Log in to EUDAMED with your Manufacturer account.
2. Select the Register a new Basic UDI-DI hyperlink in the UDI-DIs/Device section on the
homepage.

Figure 1 – 'Register a new Basic UDI-DI' hyperlink on the homepage

Result: The device registration start page prompts you to enter some basic identifying
information about the device family, including the applicable regulation and the
assigned Basic UDI-DI code received from the issuing entity:

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 EUDAMED User's Guide – UDI Device Management

Figure 2 – UDI-DI registration: start page

3. On the device registration start page, select/enter the following information:

i) the Applicable regulation,
ii) the name of the official Issuing entity that provided the Basic UDI-DI code,
and
iii) the actual Basic UDI-DI code.
Result: An additional question appears at the bottom of the page depending on the
regulation that you have selected i.e.

REGULATION ADDITIONAL QUESTION

MDR Is it a System or Procedure Pack which is a
Device itself?
+ additional sub-questions about the device type,
depending on whether you answer '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

For the rest of the procedure, we will assume in this quick user guide that you have
selected Regulation (EU) 2017/745 (i.e. MDR).

4. Answer all questions on the page, and then click Save & Next.

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 EUDAMED User's Guide – UDI Device Management

Result: Page  of the Basic UDI-DI registration wizard appears. The content of this page
will be different depending on the underlying regulation.

Figure 3 – UDI-DI registration wizard: page 1, 'Basic UDI-DI information' (MDR)

5. Complete the page with all mandatory information:
Select the This field appears only if you are a non-EU manufacturer. It is used
authorised to select the European Authorised Representative that you have
representative mandated for the device in question. The Authorised Representative
must have been validly registered in EUDAMED first (i.e. obtained
an SRN), and the manufacturer's mandate must have been
validated, and it must be active at the time of registration of the
device (otherwise the Authorised Representative will not be
available for selection in the list).

Risk class Select the risk class assigned to the medical device, resulting from
the classification rules applicable to the selected Directive/Regulation.
For MDR, the following classes are available.
Class I (Low) Class IIb (Medium-High)
Class IIa (Medium-Low) Class III (High)
The content of the page will change based on the risk class that you
have selected.

Implantable [Available only in connection with risk class

IIa/IIb/III devices]
Select the appropriate option button to indicate whether the device
is an implantable device in the meaning of the regulation i.e.,
'Any device which is intended:
- to be totally introduced into the human body or,
- to replace an epithelial surface or the surface of the eye,
by surgical intervention which is intended to remain in place after
the procedure.

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 EUDAMED User's Guide – UDI Device Management

Any device intended to be partially introduced into the human

body through surgical intervention and intended to remain in
place after the procedure for at least 30 days is also considered
an implantable device.'

Is the device a [Available only in connection with risk class IIb

suture, staple, implantable devices]
dental filing, dental Select the appropriate option button to indicate whether the device
brace (…)? is a suture, staple, dental filling, dental brace, tooth crown, screw,
wedge plate, wire, pin, clip or connector.

Measuring function Specify whether the device has a primary analytical measuring
function.

Reusable surgical [Available only in connection with non-implantable

instruments device models]
Select the appropriate option button to indicate whether the device
is a reusable surgical instrument in the meaning of the regulation
i.e.,
'Instrument intended for surgical use by cutting, drilling, sawing,
scratching, scraping, clamping, retracting, clipping or similar
procedures, without connection to any active medical device and
which can be reused after appropriate procedures have been
carried out).'

Active device Specify whether the device is an active device in the meaning of the
regulation i.e.,
'Any device, the operation of which depends on a source of
energy other than that generated by the human body for that
purpose, or by gravity, and which acts by changing the density of
or converting that energy. Devices intended to transmit energy,
substances or other elements between an active device and the
patient, without any significant change, shall not be deemed to be
active devices'.

Device intended to Select the appropriate option button to indicate whether the device
administer and/or is intended to administer and/or remove medicines, body liquids or
remove medicinal other substances to or from the body.
product

Device model Free-text box identifying the device model/family e.g. hip prosthesis.
applicable

Device name Free-text box used to enter the (generic) name of the device
model/family.
Please note that either the model or the name is mandatory.

6. Click Save & Next to move to the next page of the wizard.
Result: Page  of the UDI-DI registration wizard is enabled in certain cases only; and its
content differs based on different parameters, including selected directive/regulation,
risk class, etc.

For example:
If the device requires confirmation by a Notified Body, then the corresponding certificate must
have been issued before you may submit your device data. In some cases, you will then be
prompted to enter some extra information about the certificate in question. This is for example
the case for Class IIb implantable devices being Sutures or Staples. In such cases, page 2 of
the device registration wizard would look like this:

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 EUDAMED User's Guide – UDI Device Management

7. Enter the requested information about the certificate on the Certificate information page:
Type Examination If this field is available and you select 'Yes', then you will be
Certificate if prompted to provide the Certificate Number and Revision number
applicable (optional), and to identify the Notified body.

Certificate Type If this field is available, please enter here the type of certificate that
you have received for the device.

Certificate Number If this field is available, please enter here the unique certificate
number received for the device.

Revision Number If available and applicable, please enter here the revision number of
the certificate that you have received for the device.

Notified Body If this field is available, please enter here the code of the Notified
Body that issued the certificate.

8. Click Save & Next when finished, to move on to the next page of the wizard.
Result: Page  of the UDI-DI registration wizard appears (see next page). This is used to
enter the identification information relating to the specific variation/version of the
device.

Impact of changes to the saved information

Please be aware that if, at some point after saving the device registration form, you decide to
modify any information from the Step 1 pages of the wizard, EUDAMED will then recalculate the
type of Certificate Information to be collected. Previously completed information will be lost.
EUDAMED would then warn you before you decide to perform this operation:

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 EUDAMED User's Guide – UDI Device Management

STEP 2 Entering UDI-DI Identification Information

Pages 3-5 of the UDI-DI registration wizard are used for entering the UDI-DI identification
information relating to the specific variation/version of the medical device under the Basic
UDI-DI that you specified on the previous pages of the wizard.

Figure 4 – UDI-DI registration wizard: page 3, 'UDI-DI identification information'

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 EUDAMED User's Guide – UDI Device Management

 To enter UDI-DI identification information

1. Complete page  of the UDI-DI registration wizard as follows:
Issuing Entity Please select here the official agency that issued the UDI-DI code
for the specific device. By default, this will be the same entity as the
one that issued the Basic UDI-DI for the device family, but it can be
different.

UDI-DI code The actual unique UDI-DI code that you received from the issuing
entity for this specific device.

UDI-DI from If a second UDI-DI code was received from another issuing entity,
another entity please select 'Yes', select the issuing entity in question, and the
(secondary) secondary UDI-DI code in question.
applicable

Enter the Please look for and select the unique code associated with the
nomenclature code nomenclature term that describes the device. Can be searched by
code or by name.

Trade name The trade/brand/proprietary name of the medical device in the

applicable selected language(s), as it appears on the device label.

Reference/ The reference, catalogue or product number as found on the device

Catalogue number label or accompanying the packaging.

UDI-DI is the Direct Select the appropriate option button to indicate whether the device
marking is directly marked with a DI Code or not (is not labelled individually).

Quantity of device The number of devices within a package identified by the specified
UDI-DI.

Unit of Use DI This field appears only if you have select 'No' for 'UDI-DI is the
Direct marking' above, and a value greater than 1 to 'Quantity of
Device'. It is used to enter the actual unique DI code assigned to the
lowest unit of use that is used for the patient. Issuing entity for this
DI Code is the same as the UDI-DI.

Type of UDI-PI The options in this section describe the manner in which production
of the device is controlled i.e.
Lot or Batch The number assigned to the group of devices
Number with the same UDI-DI which have been
produced in the same process or series of
processes.
Serial Number The number that allows for the identification of
an individual device, indicating its position within
a series.
Expiry date The upper limit of the time interval during which
the performance characteristics of the device
conditions can be assured when stored under
specified conditions.
Manufacturing The date on which the device was
date manufactured.

Additional product Any additional information or details about specific features of the
description device in the selected language(s).

URL for additional A web address (URL) where additional official information on the
information (as device can be found on the Internet.
electronic
instructions for
use)

UDI-DI status Indication of the device status on the market.

2. Click Save & Next to move to the next page of the wizard.

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 EUDAMED User's Guide – UDI Device Management

Result: Page of the UDI-DI registration wizard appears:

Figure 5 – UDI-DI registration wizard: page 4, 'UDI-DI characteristics'

3. Complete page of the UDI-DI registration wizard as follows:

Clinical size Select the appropriate option button to indicate whether a numeric
applicable value for the clinically relevant size measurement of the medical
device is indicated on the label.

Labelled as single Select the appropriate option button to indicate whether the device is
use labelled as a 'single use device', i.e. a device intended for one use, or
on a single patient during a single procedure.

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Need for Select the appropriate option button to indicate whether the device
sterilisation before requires sterilization prior to use.
use

Device labelled Select the appropriate option button to indicate whether the device is
sterile labelled as 'sterile' (i.e. sterile and in a sterilised packaging).

Containing latex Select the appropriate option button to indicate whether the device or
its packaging is labelled as containing natural rubber that comes in
contact with humans.

CMR/Endocrine Select the appropriate option buttons to indicate whether the device is
disruptor labelled with an indication of the presence of substances
 which are carcinogenic, mutagenic or toxic to reproduction ('CMR'),
of either category 1A or 1B. If you select 'Yes', please identify the
substance(s) in question by their name and possibly CAS and/or
EC number from the ECHA database.
and/or
 having endocrine-disrupting properties, for which there is scientific
evidence of probable serious effects to human health. If you select
'Yes', please identify the substance(s) in question by their name in
the selected language(s) and possibly CAS and/or EC number from
the ECHA database.

Storage/handling Select the appropriate option button to indicate whether storage

conditions, if and/or handling requirements are required for the device in
Please note that if the
desired storage/
applicable accordance with Annex I, 23.2 (k) of the MDR. If you select 'Yes',
handling condition, or please specify the type(s) of storage/handling conditions in question,
the desired critical and describe those conditions.
warning or contra-
indication is not Critical warnings or Select the appropriate option button to indicate whether warnings,
available in the list, you contra-indications, contra-indications, precautions need to be brought to the immediate
can select 'Other' and if applicable attention of the user of the device, and/or to any other person. If you
enter a detailed custom select 'Yes', please specify the critical warning type(s) in question,
description in different
and describe these briefly.
languages.

4. Click Save & Next to move on to the next page of the wizard.

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Result: Page of the UDI-DI registration wizard appears:

Figure 6 – UDI-DI registration wizard: page 5, 'UDI-DI device information'

5. Complete page of the UDI-DI registration wizard as follows:

Reprocessed Select the appropriate option button to indicate whether the device is
single use device a reprocessed single-use device in the meaning given in the
legislation.

Intended purpose If the device is listed in Annex XVI of the Medical Device Regulation,
other than medical select the appropriate option button to indicate whether the intended
(Annex XVI) purpose of the device is other than a medical purpose. If you select
'Yes', please select the check box(es) corresponding to the
purpose(s) in question.

Is the device Select the appropriate option button to indicate whether the device is
designed and designed and manufactured by another legal or natural person as
manufactured by referred in Article 10(15) of the MDR. If you select 'Yes', look for and
another legal or select the SRN of the legal or natural person in question if it is already
natural person? registered in EUDAMED, or select 'I don't have an SRN and provide
the name, address and contact details of the legal or natural person in
question.

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 EUDAMED User's Guide – UDI Device Management

Clinical Select the appropriate option button to indicate whether a clinical

investigation, if investigation was performed on the medical device. If you answer
applicable 'Yes' to the subsequent question about the clinical investigation being
conducted inside the EU, click the Check registry button and select
its reference from the EUDAMED registry.

Tissues and cells Select the appropriate option buttons to indicate whether the device
is manufactured utilizing tissues or cells of human or animal origin, or
their derivatives.

Information on Select the appropriate option buttons to indicate whether the device
substances incorporates, as an integral part, any substances which, if used
separately, may be considered to be medicinal products and/or
medicinal products derived from human blood or human plasma. If
you select 'Yes' to any question, you will have to enter the name of
these substances in the selected language, and possibly their INN
(International Non-proprietary Name of an ingredient as
recommended by the World Health Organisation).

Member States of Use the selection box to select the EU Member States (i.e. at least 2)
the placing on the in which the device is placed on the market. You will then be
EU market of the prompted to specify the From and To dates of availability on the
device market (if applicable).

6. Click Save & Next to proceed to the last page of the wizard.

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 EUDAMED User's Guide – UDI Device Management

STEP 3 Entering Container Package Information

Page of the UDI-DI registration wizard is optional to complete. It is used to enter the
unique UDI-DIs assigned to each package level of the device in order to distinguish
between package quantities at each package level:

Figure 7 – UDI-DI registration wizard: page 6, 'Container package(s)'

 To enter Package UI-DI information

1. If you wish to complete page of the UDI-DI registration wizard, proceed as
follows: select the Add a container package UI-DI for this UDI-DI hyperlink for
each package level of the device, and provide the following corresponding
information:
Issuing Entity The name of the official Issuing agency that provided the Package
UDI-DI for the package level that you are describing.

Package UDI-DI The unique Package UDI-DI code corresponding to the package
value level that you are describing.

Quantity per The number of items in the package level that you are describing.
package

The calculated total number of devices for all specified containers is displayed on the
right hand-side.
2. Before submitting the UDI device registration form, first click Preview at the bottom
of the page and check every information that you have completed. If necessary, you
can still click the Back to form button to make changes to the form before submitting
it for goo.
3. When you have check the information and you are ready, click Submit .

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 EUDAMED User's Guide – UDI Device Management

Result: EUDAMED prompts you to confirm you submission:

4. Read the message and then click Submit my request.

Result: You are informed that the device has been successfully submitted and that a unique
application ID has been assigned to it. We suggest that you write down this ID for
future reference purposes:

The newly submitted device simultaneously appears on the UDI-DI Management page (homepage
> UDI-DIs/Device > Manage your UDI-DIs) with a state of 'Registered'. You can view (and edit) the
submitted information from there if necessary:

EUDAMED User's Guide – UDI Device Management Managing UDI Devices  16

Index

A L
Active devices .................................... 7 Latex ................................................. 12
Authorised representative .................. 6 Lot 10

B M
Basic UDI-DI .................................. 3, 4 Market ............................................... 14
Batch ................................................ 10 MDR................................................ 1, 2
Measuring function ............................. 7
C
Certificates
N
revision number ................................... 8 Nomenclature ..................................... 7
Clinical size ...................................... 11 Notified Bodies ................................... 8
CMR ................................................. 12
Container package ........................... 15 P
D Package UDI-DI .................................. 3
Packaging ......................................... 15
Devices
active ................................................... 7 R
container package.............................. 15
implantable........................................... 6 Regulation .......................................... 5
issuing entities ................................... 10 Reusable surgical instruments ........... 7
medical purpose................................. 13 Revision number ................................. 8
registering ............................................ 4 Risk class ........................................... 6
single use ........................................... 11
submit ................................................ 15 S
trade name ......................................... 10
Direct marking .................................. 10 Serial number ................................... 10
Directives............................................ 1 Single-use devices ........................... 11
Sterilisation ....................................... 12
E Storage/handling conditions ............. 12
Expiry date ....................................... 10 T
I Trade name ...................................... 10
Implantable devices ........................... 6 U
Intended purpose ............................. 13
Issuing entities ................................. 10 UDI...................................................... 3
UDI-DI ................................................. 3
UDI-DI code ...................................... 10

EUDAMED User's Guide – UDI Device Management Index  17