User Manual

User Manual
These Excel templates make extensive use of macros, they manage the versions and the dynamic mandatory field
displays. Microsoft has a lot of security around macros and to activate the macros there are a few small things you must
do on your system.
Please make sure that you use these in a trusted location, trusted locations are set in Excel. Click on File, go to Options,
Trust Center, Trust Center Settings (Button), Menu Trusted Locations, and add a new location. This means that you trust
the spreadsheets in this location and the macros will run. Excel disables macros if the spreadsheet is not in a trusted
location. Macros are heavily used throughout the spreadsheets and they must be enabled.
Additional Microsoft instructions to enable macros: https://support.office.com/en-us/article/enable-or-disable-macros-

in-office-files-12b036fd-d140-4e74-b45e-16fed1a7e5c6
Note 1: This spreadsheet uses Basic UDI and UDI DI's to join the various tabbed data. If you do not have a DI for your
product then a fake one must be generated. If you are a subscriber to our Converter package and would like us to
generate these fake DI’s for you we can manage this, otherwise, you will need to create a fake Basic UDI and UDI DI
yourself. If you wish to leave the creation to us then for now you will need to manage a very basic numbering.
In the fields Basic UDI and UDI DI you will need to create a basic number. For a Fake basic UDI please use 'Fake-B-' and a
number, e.g. 'Fake-B-1'. For the UDI DI please use 'Fake-D-' and the same number selection e.g. 'Fake-D-1'. These have
to be used in every template you create records in. Later when you upload your spreadsheet to our system we will use
these to join the data tabs and create a Fake DI for you.
Note 2: For the substances tabs, each individual substance can have a description entered in multiple languages. To
manage this the field 'Substance Group ID' must be populated with a number, the first being considered as your default
language. If you enter a substance with multiple languages then this field is set to 1 and used for each associated
translated entry, this is used to information. If you have more than one substance type then you must group these
entries by using their ID field, 1, 2, 3 etc.
MDR Eudamed Training | Support | Consultancy | Data preparation - EC submissions | M2M Access Points
Eudamed.eu | Brussels, Belgium | Sofia, Bulgaria © 2019 Eudamed Ltd.
Dashboard (Navigation)
There are a lot of tabs within these spreadsheets, with the MDR being the biggest. Navigation of these tabs was always
going to be difficult so we have added some to help you. The dashboard has two graphs to show you the row and latest
version counts on each tab, clicking on the tab name will bring you directly to the selected tab.
Click here to navigate to a tab Company who owns the template licence.
Notes: Companies who wish to use the template throughout their subsidiaries who are companies in their own right will
require a licence for each subsidiary.
To return to the dashboard from any tab click the Home button on the top of the tab
To add a new row with the required fields highlighted, click new.
Info & Config
This tab contains some overall rules that the EC is enforcing with their data uploads. Also on this tab, there are a few
functional options that will help with the overall user experience.
The legend shows the colour scheme used throughout the system.
These colours are to guide you with the mandatory and applicable fields and tabs. If a tab is required then you must
include at least one entry per BasicUDI or UDIDI. The optional tabs are just that optional however on each of these tabs
there are mandatory fields if you enter data.
Mandatory fields must be populated before uploading to the EC or you will fail with your EC uploads. As soon as you
enter data the mandatory field removes the mandatory colour, this is to help you identify missed fields. Some fields are
not mandatory however depending on what you select they affect others that then become mandatory.
For example, with medicinal substances, as soon as you add a new row the mandatory fields are highlighted.
However, if you enter an INN code the mandatory fields change.
On the Info Tab, there are also some items to make things easier on you.
For example, for Non-EU manufactures selecting the checkbox ensures that the Authorised Representative SRN is
always mandatory in the subsequent tabs. The other options relate to how the data is displayed and filtered for you.
Eudamed Uploads/Bulk Upload Conversion
These templates help you prepare your data for Eudamed submissions. Eudamed.eu provides services to take these
populated templates and upload the data to the EC on your behalf. All the information on this tab relates to our services
being used for the data submissions.
There is a column on each of the four tabs where a new version can be created called Eudamed upload. This is a flag
that will be used in the future by Eudamed.eu if you choose our services to upload your data to the European
Commissions Eudamed. On the ‘Eudamed upload’ tab there are additional functions to switch on or off multiples of
these flags. When using the Eudamed.eu services only Basic UDI’s, UDI DI’s, Market Info, and Packaging will be uploaded
if these flags a set to true. Rows with the False setting will not be uploaded.
The Validator
Eudamed.eu can help validate your data using our ‘Validator service’. This service allows you to upload your
spreadsheet and our system imported the data, validates it against business rules and the XSD fields. For the Basic UDI
and UDI DI PDF files are created which highlight fields that are incomplete and warns on failed business rules or missing
data sections.
The Convertor
The Convertor package includes Validator services. Following the Validator process if the user is subscribed to the
Convertor package then the uploaded data, if it is error-free, is converted to the specific XML required by the European
Commission and EUDAMED. The resulting XML files are made available to the user for upload to EUDAMED via the
transmission form. This is a very cost-effective way of submitting the data to EUDAMED, for example, if you have 15000
devices then under the EUDAMED rules this is only 50 files to upload and saves companies thousands against the
machine to machine options on the market.
Contact sales@eudamed.eu for more information
Overview
Eudamed is a complicated system with many business rules. We have included some of those rules in these templates
and by creating one template per regulation or directive we have been able to manage most of the mandatory fields
and as many rules as possible.
There are one main rules in Eudamed, every UDI DI must have a Basic UDI as a parent. These means that for each Basic
UDI there can be many UDI DI’s. Certain fields or elements in the Basic UDI and the UDI DI structures allow for multiple
rows/records to be associated with them. To allow for this in our template for each section that allows for multiple
entries we have created a new tab. Each tab is joined to its parent with a key, the Basic UDI joins all tabs prefixed with
BasicUDI and the UDIDIs tab. Each UDI DI has the key UDI DI and this is used to join all tabs prefixed with UDIDI.
Eudamed and the spreadsheet allow for versioning of BasicUDI, UDI DI, Market Info and Packaging. Each can be
versioned independently and this means that if for example, you update the UDI DI version this does not affect the Basic
UDI version. The same with Packaging, updating the version of Packaging does nor affect the UDI DI version.
When you version a BasicUDI or UDI DI, their associated tabs take a copy of the latest version records and duplicates
them to maintain the correct information per version. This is exactly how Eudamed works and we have to maintain the
correct versions for later uploading. If you think of a UDI DI as one line in a spreadsheet, and you wish to create a new
version then you would copy that one line and update the specific fields in the new line. This is what we do with our
spreadsheet, the only difference is that your one line can be spread across many tabs.
Packaging and Market Info have slight differences with versioning. When you version a UDI DI both Packaging and
Market Info have their records duplicated and the UDI DI version increased as every other tab, however, there is one
difference. Packaging and Market Info also maintain their own versions. You can version Packaging and Market Info on
their own, increasing the Packaging and Market Info version number by one but not changing the Packaging and Market
Info version number. The opposite happens with the UDI DI versioning then the Packaging and Market Info version
number is not changed only the UDI DI version number and the latest version flag is updated.
Packaging version UDI DI version
Latest version flagged is maintained
Note: Every Tab requires a key so they can be joined to the correct records later for upload to Eudamed, the Basic UDI
and the UDI DI are the system keys combined with the latest version and must be maintained.
Versions
There are four places where records may be versioned, Basic UDI, UDI DI, UDIDI MarketInfo, and UDIDI Packages.
To create a new version of a record, Basic UDI or UDI DI, select the full row of the latest version of the record you wish
to create a new version of and then click on the ‘new version’ button. The system will then go over every associated tab,
select the records with the matching BasicUDI or UDI DI, with the latest version flag set, and duplicate the rows updating
the version flag and the newly increased Version number.
Basic UDI
Highlight Row Click “New Version”
Set to Y and full row selected to version
Basic UDI Tab
The latest version is Basic UDI version 2.
UDIDIs Tab
To version a UDI DI both Latest Versions must be set to Y and full row selected to version
After versioning a BasicUDI the latest version of the UDI DI remains at 1 and the latest version of the Basic UDI version 2.
NOTE: To increase the version of a Basic UDI or a UDI DI you select one full row.
When versioning Market Info and Packaging as with the UDI DI you must select the full row and latest version. For
Market Info and Packaging there are two latest version columns, both must be set to Y for a row to version.
To increase the version of Market Info or of Packaging, you must select only one row with the both ‘Latest version’
fields set to ‘Y’. All matching or associated rows with the latest version and the specific UDI DI, and Market or Packaging
version will be versioned too.
UDIDI Market Info
Both set to Y and full row selected to version
UDIDI Packaging
Both set to Y and full row selected to version
Tab and Field explanations
BASIC UDI TAB

You must ensure the correct version is maintained and if applicable the latest version flag is set to Y
Latest Version (Basic UDI)

This is a spreadsheet specific field, the only accepted entry is Y, this field in conjunction with the version number is used
to manage versioning throughout the system. The Basic UDI has 4 associated tabs where the Basic UDI version is used,
BasicUDI, BasicUDI AR Comments, BasicUDI CertificateLinks, BasicUDI ClinicalInvestigations, and UDIDIs. When the Basic
UDI version is updated by pressing the New Version button, all rows in each associated tab(s) with the same Basic UDI,
Version number, and Latest Version = Y are duplicated to allow you to make the necessary changes on a new version.
Basic UDI
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.
Applicable Legislation
You must select the appropriate legislation for the row entry. Each spreadsheet has different legislations listed.
Basic UDI Issuing Entity

Assigned Issuing Entities that will generate the DI Codes allocated for all DI`s inside Eudamed (Basic UDI DI, UDI-DI, Unit
of Use DI, Secondary Di, Package level DI).
Authorised Representative SRN

This field is required only if you are a non-EU manufacturer. It is used to select the European Authorised Representative
that you have mandated for the device in question. A valid Authorised Representative must be registered in EUDAMED
and have a valid SRN.
Legal Manufacturer SRN

SRN of the Manufacturer that registers the Device.
Risk class
Select the risk class assigned to the medical device, resulting from the classification rules applicable to the selected
Directive/Regulation.
Is it a System which is a Device in itself, Procedure pack which is a Device in itself or Kit
Property defines if the Basic UDI-DI is referring to a System which is a Device in itself, Procedure pack which is a Device
in itself (in accordance with the Art. 22(4) MDR) or Kit.
MDR Type
Select if it is a System, Procedure Pack or Device.
Special Device Type option (Boolean)

Property defines if the Device is a Special Device Type.
Special Device Type
If this is a special device type, the specific type category must be selected
IVDR Microbial Substances (Boolean)

Property defines if the device contains presence of substances of microbial origin
Device model (either the model or the name is mandatory.)

Free-text box identifying the device model/family e.g. hip prosthesis.
Device name
Free-text box used to enter the (generic) name of the device model/family.
Animal Tissues Cells (Boolean)

Defines if the Device has presence of animal tissues or cells or their derivates
Human Tissues Cells (Boolean)

Defines if the Device has presence of human tissues or cells or their derivates
Medicinal Product Check (Boolean)

Defines if the Device contains substances which may be considered medicinal product
Human Product Check (Boolean)

Defines if the Device contains substances which may be considered medicinal product derived from human blood or
plasma
MDR Active device (Boolean)

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'.
MDR Device intended to administer and/or remove medicinal product (Boolean)

Select the appropriate option button to indicate whether the device is intended to administer and/or remove medicines,
body liquids or other substances to or from the body.
MDR Implantable (Boolean) Required for risk class IIa/IIb/III devices

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.'
MDR IIb implantable exceptions (Boolean) Is the device a suture, staple, dental filing, dental brace (…)?
Only required for risk class IIb implantable devices.
Property defines if the registered Device is 'sutures', 'staples', 'dental fillings', 'dental braces', 'tooth crowns', 'screws',
'wedges', 'plates wires', 'pins', 'clips and connectors' (these defines are exempted from the regulation imposed to
implantable devices).
Property is applicable only for Devices having Risk Class II b and having the property 'Implantable' marked
MDR Reusable surgical instruments (Boolean) only for non-implantable device models
Select the appropriate option to indicate whether the device is a reusable surgical instrument as per the regulations
'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).'
MDR Measuring function (Boolean)

Specify whether the device has a primary analytical measuring function.
IVDR Companion Diagnostic (Boolean)

Property defines if the device corresponds to a device that has a role of Companion Diagnostic device or not.
'Companion diagnostic’ means a device which is essential for the safe and effective use of a corresponding medicinal
product to:
- identify, before and/or during treatment, patients who are most likely to benefit from the corresponding medicinal
product; or
- identify, before and/or during treatment, patients likely to be at increased risk of serious adverse reactions as a result
of treatment with the corresponding medicinal product.
IVDR Instrument (Boolean)

Property defines if the device is an Instrument or not.
IVDR Kit (Boolean)

Property defines if the Basic UDI-DI is referring to a System which is a Device in itself, Procedure pack which is a Device
in itself (in accordance with the Art. 22(4) MDR) or Kit.
IVDR Near Patient Testing (Boolean)

Property defines if the device is Near Patient testing or not.
'Device for near-patient testing’ means any device that is not intended for self-testing but is intended to perform testing
outside a laboratory environment, generally near to, or at the side of, the patient by a health professional;
IVDR Professional Testing (Boolean)

Property defines if the device is designed to be used for Professional Testing or not.
IVDR Reagent (Boolean)

Property defines if the device is a reagent or not.
IVDR Self Testing (Boolean)

Property defines if the device is Self-Patient testing device or not.
'Device for self-testing’ means any device intended by the manufacturer to be used by lay persons, including devices
used for testing services offered to lay persons by means of information society services;
BASIC UDI CERTIFICATE TAB
You must make sure the correct Basic UDI is provided and if applicable the latest version flag is set to Y
Certificate Type
Select the type of certificate that you have received for the device.
Certificate Number
Enter the unique certificate number received for the device.
Revision Number
Enter the revision number of the certificate that you have received for the device.
Notified Body
Enter the code of the Notified Body that issued the certificate.
Certificate Expiry Date

The date the certificate expires
Decision
Decision is related to the Confirmation decision taken by the Notified Body regarding the validation/ confirmation
of the details entered by the Manufacturer in the Device Data.
Comment
Any comments from the AR relating to the certificate
Decision Date
The date the decision was given
BASIC UDI CLINICAL INVESTIGATIONS TAB

You must make sure the correct Basic UDI is provided and if applicable the latest version flag is set to Y
Clinical Investigation Reference

Enter the clinical investigation reference number
Non-EU Applicable Countries

If the clinical investigation was undertaken outside the EU then you must select each country where the
investigation was performed, repeat the investigation reference for each country.
UDI DI TAB
Latest Version (Basic UDI)
This is a spreadsheet specific field, the only accepted entry is Y, this field in conjunction with the version number is
used to manage versioning throughout the system. When the UDI DI version is updated by selecting the UDI DI latest
version row and pressing the New Version button, all rows in each associated tab(s) with the same Basic UDI, Version
number, and Latest Version = Y are duplicated to allow you to make the necessary changes on a new version.
UDI DI Version
The version of the UDI DI row.
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.
Issuing Entity
The issuing agency that issued the UDI-DI code for the specific device.
UDI-DI code
The actual unique UDI-DI code that you received from the issuing entity for this specific device.
Basic UDI
The Basic UDI associated with the UDI DI record being entered
Latest Basic UDI Version

If this is the latest version of the Basic UDI, Y must be selected
Basic UDI Version

The version number of the Basic UDI this UDI DI is associated with,
Secondary UDI DI
If a second UDI-DI code was received from another issuing entity, please select 'Yes', select the issuing entity in
question, and the secondary UDI-DI code in question.
Secondary Issuing Entity

The issuing agency that issued the secondary UDI-DI code for the specific device.
UDI DI direct marking (Boolean)

Direct Marking UDI-DI - is the DI with which the Device (UDI-DI) is marked directly
The field is mandatory when the Device is directly marked (Direct Marking = True). The value of the field is a DI -
either the current UDI-DI (of the current device) or a different UDI-DI.
Quantity of Device
The base quantity in which the Device is provided. The field should be a default value 1.
Direct Marking UDI DI

Direct Marking UDI-DI - is the DI with which the Device (UDI-DI) is marked directly
The field is mandatory when the Device is directly marked (Direct Marking = True). The value of the field is a DI -
either the current UDI-DI (of the current device) or a different UDI-DI.
Direct Marking Issuing Entity
Assigned Issuing Entities that will generate the DI Codes allocated for all DI`s inside Eudamed (Basic UDI DI, UDI-DI,
Unit of Use DI, Secondary Di, Package level DI).
Unit of Use DI
Unit of Use DI - reference to the Unit of Use DI applicable for the current UDI-DI (Device Identifier). A virtual
identifier assigned to an individual medical device when a Unique Device Identifier (UDI) is not labelled on the
individual device at the level of its unit of use. Its purpose is to associate the use of a device to/on a patient when a
base package contains more than one device.
The field is mandatory when the value of the field Direct marking is false and Quantity of Device is more than 1.
Unit of Use DI Issuing Entity

Assigned Issuing Entities that will generate the DI Codes allocated for all DI`s inside Eudamed (Basic UDI DI, UDI-DI,
Unit of Use DI, Secondary DI, Package level DI).
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.
Related UDI DI (Related Legacy Device)

UDI-DI related to the current UDI-DI / EUDAMED ID.
The reference will be used to express the link between a Regulation Device and a Legacy Device (to show that is the
same Device). Relationship will be from the Regulation Device to the Legacy Device
Related UDI DI Issuing Entity

Select the issuing entity
Relationship Type
Type of Relationship created between Devices (UDI-DI`s).
The relationships between the different Devices (UDI-DI`s) can be of several types (defining the business context that
implied creating the relationship between these Devices)
Member State of the placing on the EU market of the device

Defines the first Country were the device has been placed on the Market (Member State in which the device is to or
has been placed on the market in the Union). The Tab UDIDI Market Info is where all the countries are entered.
Device Status
Status of the Device (On the market, No longer placed on the market, Not For EU Market). Indication of the device
status on the market.
Status Date
Date from which the current Device Status applies.
MDR Reprocessed single-use device (Boolean)

Indicate whether the device is a reprocessed single-use device in the meaning given in the legislation.
Labelled as single-use (Boolean)

Property defines if the Device is a Labelled as a Single-use or not
Max Number of Reuses
Property defines the Maximum Number of reuses applicable for the Device.
The field is optional and can be completed if the Device is not marked as a single-use device (Single Use = false).
URL for additional information

A web address (URL) where additional official information on the device can be found on the Internet.
Reference Catalogue Number

The reference, catalogue or product number as found on the device label or accompanying the packaging.
Device Labelled Sterile (Boolean)

Select the appropriate option button to indicate whether the device is labelled as 'sterile' (i.e. sterile and in a
sterilised packaging).
Need for sterilisation before use (Boolean)

Select the appropriate option button to indicate whether the device requires sterilization before use.
MDR Containing latex (Boolean)

Indicate whether the device or its packaging is labelled as containing natural rubber that comes in contact with
humans.
IVDR New Device

Defines if the Device can be considered a 'New' Device or not.
A device shall be considered to be ‘new’ if:

(a) there has been no such device continuously available on the Union market during the previous three 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 years.
UDIDI PRODUCTION IDENTIFIER TAB
Basic UDI
The Basic UDI associated with the UDI DI
UDI DI
The UDI DI this row(s) is associated with, multiple rows per UDI DI are allowed.
UDI DI Version
The UDI DI version this row(s) is associated with.
Latest Version
This flag refers to the latest version of the UDI DI
Type of UDI-PI
The options in this section describe how the production of the device is controlled i.e.
Lot or Batch Number

The number assigned to the group of devices 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 date
The date on which the device was manufactured.
UDI DI TRADE NAMES TAB

Basic UDI
UDI DI
UDI DI Version
Latest Version
Trade name language

The language the trade name is entered in.
Trade Name:
The trade/brand/proprietary name of the medical device in the selected language(s), as it appears on the device
label.
UDI DI MDN CODE TAB (Nomenclature)
Basic UDI
UDI DI
UDI DI Version
Latest Version
MDN Code (Nomenclature)
This code is the CND code or soon to be named EMDN. GMDN codes are not acceptable, only CND codes. Multiple
rows can be entered.
UDIDI ADDITIONAL DESCRIPTION TAB

Basic UDI
UDI DI
UDI DI Version
Latest Version
Additional Description Language

The language the trade name is entered in.
Additional Description:
Any additional information or details about specific features of the device in the selected language(s).
UDIDI DEVICE SUB STATUS TAB
Basic UDI
UDI DI
UDI DI Version
Latest Version
Device Sub status

Sub Status of the Device (Recalled, Field safety corrective action initiated)
Scope of Recall
When the Status of a Device is set to FSCA Initiated or Recall, details about the Scope of the Recall/ FSCA are
required (description of the serial number/lot number, etc.)
The field defines how the Scope of the Recall is defined (by Lot Number, Serial Number, etc.)
Recall Precision Lang

The language of the recall precision text entry
Recall Precision text

When the Status of a Device is set to FSCA Initiated or Recall, details about the Scope of the Recall/ FSCA are
required (description of the serial number/lot number, etc.)
Field stores the details of the recalled elements (batch numbers, lots numbers, etc.) of the Device - when the Scope
of Recalled is entered manually by the user (not by referencing an FSN)
Sub status StartDate

Start Date when the Sub status has been initialised
Sub status end date

End date when the Sub status has been closed, In Eudamed this will be triggered by Vigilance module.
UDIDI ANNEX XVI TAB (MDR)
Basic UDI
UDI DI
UDI DI Version
Latest Version
Intended purpose other than medical (Annex XVI)

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

Is the device designed and manufactured by another legal or natural person?
Indicate whether the device is designed and manufactured by another legal or natural person as referred in Article
10(15) of the MDR. Enter the SRN of the legal or natural person in question, if they are already registered in
EUDAMED, otherwise enter the name, address and contact details of the legal or natural person in question.
UDIDI STORAGE HANDLING CONDITIONS TAB
Basic UDI
UDI DI
UDI DI Version
Latest Version
Storage handling conditions

Storage and handling conditions specified on the Label of the Device or in the Instruction of Use have to be
registered in EUDAMED - if applicable.
The field stores the Type of Storage and Handling Conditions. The field is Applicable only when the type of Conditions
for Use have the Type Storage/handling Conditions, required in this case.
Storage Handling Comment lang

The language of the Storage Handling Comment to being provided
Storage Handling Comment

Comments or description associated with the values selected from the Storage or handling Conditions or Critical
warnings
UDIDI CRITICAL WARNINGS TAB

Critical warnings or contra-indications, if applicable
These indicate whether warnings, contra-indications, precautions need to be brought to the immediate attention of
the user of the device, and/or to any other person.
Basic UDI
UDI DI
UDI DI Version
Latest Version
UDIDI Critical Warnings

Critical Warnings or Contra-Indications specified on the Label of the Device or in the Instruction of Use have to be
registered in EUDAMED - if applicable.
Field stores the Type of Critical Warnings or Contra-Indications, being required in this case.
Critical Warnings Comment lang
The field stores the language of the critical warnings comment
Critical Warnings Comment

Comments or description associated with the values selected for the Critical warnings
UDIDI MARKET INFO TAB

Note: There can be multiple market entries per individual market version.
Member States of the placing on the EU market of the device. Select the EU Member States (i.e. at least 2) in which
the device is placed on the market.
Latest Version
This flag refers to the latest version of this Market Info entries.
Mkt Version
This is version relating to the marketing country row(s) is associated with.
Basic UDI
UDI DI
UDI DI Version
The UDI DI version these marketing entry row(s) is associated with.
Latest UDI DI Version

Country
Details regarding the Countries were the Device (UDI-DI) is made available on the market. There can be a Start Date
(optional) and an End Date (also optional) of making available on a specific market the product.
Field stores details about the Country were the Device is made available on the market
Market Start Date

Details regarding the Countries were the Device (UDI-DI) is made available on the market. There can be a Start Date
(optional) and an End Date (also optional) of making available on a specific market the product.
Field stores details about the Start Date when the Device is made available on the marked
Market End Date

Field stores details about the End Date when the Device is made available on the marked
If you change marketing structures, add or leave a market then you must create a new version of the entire
marketing structure.
UDIDI PACKAGING TAB
Container Packaging Structure is a hierarchical structure defining how the Device is packaged together for shipping
and selling reasons. The definition of the structure starts from the highest element in the Container Package
structure (the element) When defining the package structure, it starts from the highest element in the structure
(highest package in the structure) which contains no more parents and continues till the UDI-DI. For all structures
defined, the last element (lowest element in the structure) defined must be the UDI-DI.
In simple terms when you are entering your packaging, consider you are starting with a complete container ready for
unpacking, the first internal container you take out is your first entry, and last entry the outer container is the
package associated with the overall UDI DI.
You are allowed to enter multiple packaging structures; the packaging structure is connected to the UDI DI by
entering this value in the very last Child DI field. You must maintain the correct parent and child structures. The last
entry connects the container to the associated UDI DI. The last Child DI of the structure being entered is the
connection to UDI DI. The Parent DI of the last box is the next box inside the structure.
If you change structures or take a box off the market for example you must create a new version of the entire
structure.
E.g. UDI DI M991CVS12130NES2 (version 1) uses a container that has 3 boxes including the main container which is
connected to the UDI DI.
Container 1: 2 boxes inside with the DI of M991CVS12130NES5.
Inside each M991CVS12130NES5 there are 4 boxes (M991CVS12130NES4)
Inside each M991CVS12130NES4 there are 3 boxes M991CVS12130NES3.
Container 1:
Entry 3: Parent DI = M991CVS12130NES3
Child DI = M991CVS12130NES4
Qty = 3
Pkg Version = 1
Latest Version = Y
Package_Order = 3
Child DI = M991CVS12130NES5
Qty = 4
Pkg Version = 1
Latest Version = Y
Package_Order = 2
Child DI = M991CVS12130NES2 (UDI DI)
Qty = 2
Pkg Version = 1
Latest Version = Y
Package_Order = 1
To add another complete container, ensure a similar bottom-up structure is maintained, this is a Eudamed
requirement.
 If you created a new version of the UDI DI the two containers would be duplicated and the ned UDI DI
version updated, this would not affect the Packaging version.
 If you version this version 1 of the packaging, this would be necessary if you added/changed the packaging,
then the UDI DI version number is unaffected by this versioning.
Note: There can be multiple market entries per individual packaging version.
Latest Version
This flag refers to the latest version of these Packaging entries.
Packaging Version
This is version relating to the Packaging row(s) is associated with.
Basic UDI
UDI DI
UDI DI Version
The UDI DI version these marketing entry row(s) is associated with.
Latest UDI DI Version

Parent DI
Unique identifier of the Package UDI-DI.
Parent Issuing Entity

The issuing entity of the Parent DI
Child Package DI
Container Packaging Structure is a hierarchical structure defining how the Device is packaged together for shipping
and selling reasons. The definition of the structure starts from the highest element in the Container Package
structure (the element) When defining the package structure, it starts from the highest element in the structure
(highest package in the structure) which contains no more parents and continues till the UDI-DI. For all structures
defined, the last element (lowest element in the structure) defined must be the UDI-DI.
The field stores a link to the child element in the structure. The field will not be provided for the lowest element - the
UDI-DI
Child Package Issuing Entity

The issuing entity of the child DI
Container Pack Status

Status of the Container Package element (On the market, No longer placed on the market)
Package status date

Date from which the current Status applies.
Quantity per package
Number of Items in the Package Structure.
Used when describing the Container Packaging Structure of a Device.
Package Order
The Package_Order field is used to manage the order sequence of the packages, this is crucial creating the XML. The
main container connected to the UDI DI must be Package_Order = 1. Then like Russian Dolls 1 package inside another
increasing the Package_Order field each time, this is used to manage the sequence when creating the XML, the main
container connected to the UDI DI must be Package_Order as you create another package.
UDIDI CMR SUBSTANCES TAB (MDR)
Basic UDI
UDI DI
UDI DI Version
Latest Version
Substance group id
For the substances tabs, each individual substance can have a description entered in multiple languages. To manage
this the field 'Substance Group ID' must be populated with a number, the first being considered as your default
substance group id Fake Substance Language
1 Test English
1 Prueba Spanish
1 Tester French
2 Results English
2 Résultats Spanish
2 Résultats French
CMR Substance Type

The field stores the Type of CMR Substance. It is only applicable when the Substance registered is a CMR Substance
CASCode
Field stores the CAS Code (CAS#) associated with the CMR substance.
CAS# can be provided only for CMR or Endocrine-disrupting substances
ECCode
Field Stores the EC Code (EC#) associated with the CMR or Endocrine-disrupting substance.
EC# can be provided only for CMR or Endocrine-disrupting substances
CMR Substance Lang

The field stores the language of the substances
CMR Substance
The field stores the Name of Substance
The field is not required in case the #EC or # CAS code is provided
UDIDI CMR ENDOCRINE TAB (MDR)
Basic UDI
UDI DI
UDI DI Version
Latest Version
Substance group id
1 Test English
1 Prueba Spanish
1 Tester French
2 Results English
2 Résultats French
CASCode
Field stores the CAS Code (CAS#) associated with the CMR substance.
CAS# can be provided only for CMR or Endocrine-disrupting substances
ECCode
Field Stores the EC Code (EC#) associated with the CMR or Endocrine-disrupting substance.
EC# can be provided only for CMR or Endocrine-disrupting substances
Endocrine Substance Lang

The field stores the language of the substances
Endocrine Substance
The field stores the Name of Substance
The field is not required in case the #EC or # CAS code is provided
UDIDI MEDICAL HUMAN SUBSTANCES (MDR)
Basic UDI
UDI DI
UDI DI Version
Latest Version
Substance group id
1 Test English
1 Prueba Spanish
1 Tester French
2 Results English
2 Résultats French
Medical Human Product Substance Type

Type of Substance (Presence of a substance which, if used separately, may be considered to be a medicinal product/
Presence of a substance which, if used separately, may be considered to be a medicinal product derived from human
blood or human plasma)
The field stores the details regarding the type of medicinal substance registered (Substance which can be considered
a Medicinal Product or Substance which may be considered a medicinal product derived from human blood or
plasma)
INN
INN (International Non-proprietary Name of an ingredient as recommended by the World Health Organisation)
Field stores the INN value for the substance provided.
INN can be provided only for substances which, if used separately, may be considered to be a medicinal product or
substances which, if used separately, may be considered to be a medicinal product derived from human blood or
human plasma.
Name of Substance Lang
Language of the Name of Substance entry
Name of Substance
When registering a new Device containing in its composition substances (substances being CMR of category 1A or
1B / substances having endocrine-disrupting properties/ substances which, if used separately, may be considered to
be a medicinal product/ substances which, if used separately, may be considered to be a medicinal product derived
from human blood or human plasma), Manufacturer will have to submit the details of those substances
Field stores the Name of Substance (applicable for all types of substances - CMR, Endocrine, Medicinal product,
Medicinal product derived from human blood or human).
In case of CMR Substances or Medicinal product and Medicinal product derived from human blood or human plasma,
if the #CAS or #EC or INN (International Non-proprietary Name of an ingredient as recommended by the World
Health Organisation) is provided, the field is no longer required.
UDIDI CLINICAL SIZE TAB (MDR)
Basic UDI
UDI DI
UDI DI Version
Latest Version
Clinical Size Precision

Device Clinical Sizes can be provided if applicable. Several Clinical Sizes can be added for the Device. Clinical Size will
be defined by the Type, Precision, Value (either Range, single value or Text) and Measuring Unit
Clinical Size Precision - mentions how the recording of Data will be performed (as Value, Range or Text is selected)
Clinical Size Type

The Type of Clinical Size (example: length, width, etc.)
Measure unit
Clinical Size Measure Unit
Value text
The value that the Clinical Size can get (when Text is selected as Precision)
Value Maximum
Maximum Value that the Clinical Size can get (when Range is selected as precision)
Value Minimum
Value (Minimum) that the Clinical Size can get (when Value or Range is selected as precision)

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Additional Microsoft instructions to enable macros: https://support.office.com/en-us/article/enable-or-disable-macros-

However, if you enter an INN code the mandatory fields change.

Contact sales@eudamed.eu for more information

Packaging version UDI DI version

Latest version flagged is maintained

Highlight Row Click “New Version”

Set to Y and full row selected to version

Basic UDI Tab

The latest version is Basic UDI version 2.

UDIDI Market Info

Both set to Y and full row selected to version

Both set to Y and full row selected to version

BASIC UDI TAB

Latest Version (Basic UDI)

Basic UDI Issuing Entity

Authorised Representative SRN

Legal Manufacturer SRN

Special Device Type option (Boolean)

IVDR Microbial Substances (Boolean)

Device model (either the model or the name is mandatory.)

Animal Tissues Cells (Boolean)

Human Tissues Cells (Boolean)

Medicinal Product Check (Boolean)

Human Product Check (Boolean)

MDR Active device (Boolean)

MDR Device intended to administer and/or remove medicinal product (Boolean)

MDR Implantable (Boolean) Required for risk class IIa/IIb/III devices

MDR Measuring function (Boolean)

IVDR Companion Diagnostic (Boolean)

IVDR Instrument (Boolean)

IVDR Kit (Boolean)

IVDR Near Patient Testing (Boolean)

IVDR Professional Testing (Boolean)

IVDR Reagent (Boolean)

IVDR Self Testing (Boolean)

Certificate Expiry Date

BASIC UDI CLINICAL INVESTIGATIONS TAB

Clinical Investigation Reference

Non-EU Applicable Countries

Latest Basic UDI Version

Basic UDI Version

Secondary Issuing Entity

UDI DI direct marking (Boolean)

Direct Marking UDI DI

Unit of Use DI Issuing Entity

Related UDI DI (Related Legacy Device)

Related UDI DI Issuing Entity

Member State of the placing on the EU market of the device

MDR Reprocessed single-use device (Boolean)

Labelled as single-use (Boolean)

URL for additional information

Reference Catalogue Number

Device Labelled Sterile (Boolean)

Need for sterilisation before use (Boolean)

MDR Containing latex (Boolean)

IVDR New Device

A device shall be considered to be ‘new’ if:

Lot or Batch Number

UDI DI TRADE NAMES TAB