Introduction

The purpose of this document is to give an understanding over the data that is to be provided to Eudamed and
communicated through Data Exchange process for the UDI/Device module.

The document presents the different attributes related to UDI/Device that may be communicated through XML
the fields from EUDAMED User Interface, the description of each field apart and the Rules applying at the level
specific field apart.

Each attribute is defined by the Entity were it resides and the attribute name.

Document sections (sheets)

Data Dictionary Fields

Entities

DD Basic UDI

DD NB related

DD UDI-DI

DD Legacy devices

DD Basic UDI_SPPP

DD UDI-DI_SPPP

DD Container Pack

DD AR related

DD Common Entities
ent is to give an understanding over the data that is to be provided to Eudamed and that can be
ta Exchange process for the UDI/Device module.

e different attributes related to UDI/Device that may be communicated through XML, their correspondence to
User Interface, the description of each field apart and the Rules applying at the level of the Entity of for each

y the Entity were it resides and the attribute name.

Section contains a description of the fields used in the data dictionary

Section contains the list of Entities in MDR EUDAMED system involved in the Data Exchange
process for the module described, a description of the Entity and the Business Rules applicable at
the level of each Entity apart
Section contains all the fields related to the Basic UDI main Entity and other Entities associated to
the Basic UDI for device(s) that are managed/affected by a manufacturer.

Section contains all the fields related to the entities associated to the Basic UDI-DI that can be
affected only by the Notified Bodies. Decision for confirmation are managed automatically from
certificate registration, SS(C)P automatically from certificate registration or directly in UDI/device.

Section contains all the fields related to the UDI main Entity and other Entities associated to the
UDI for a device that are managed/affected by a manufacturer.

Section contains all the fields related to the EUDAMED DI , EUDAMED ID and related entities for
the Legacy Devices.

Section contains all the fields related to the Basic UDI main Entity and other Entities associated to
the Basic UDI for a System or Procedure Pack that are managed/affected by a System or Procedure
Pack Producer.

Section contains all the fields related to the UDI main Entity and other Entities associated to the
UDI for a System or Procedure Pack that are managed/affected by a System or Procedure Pack
Producer.

Section contains the fields related to the Container Package. Container Package details can be
registered for Regulation Devices or System or Procedure Packs
Section contains all the fields related to the entities associated to the Basic UDI-DI that can be
affected only by the Authorised Representatives (Optional, not implemented yet).

Section contains all the fields and entities that are common for all types of Devices and Container
Package
 Field ID
Entity Name

Field Label

Field Description/Notes

ENUM Reference Code

Field Type

Field Size

Multilingual Flag
Occurrence
Searchable
 GDPR Flag

Public Access Flag

Updateable

MDR (MDD/AIMDD)

IVDR (IVDD)

DTX Entity Name

DTX XSD Element Name
Unique ID for the label (technical field. assigned by the BA)
Entity model class name. (technnical field. Use naming convention as per class name in
entity model)
Field label in EN language as it appears at the GUI. NOTE: each field label needs to be
recordet in the label log

Field description in EN language. Field related notes which will be transposed to EA and will
be visible in the data model related documentation generated from EA
Reference code to the enum list used by the field

Description of the type of the field . The field type can be a technical field type or can be of a
reference to another Entity.

Type of technical fields used : String (list of characters) , Date , Boolean (True or False),
Enum (enumeration - list of values. The code of the exact enumeration where the values are
available is described in the 'ENUM Reference Code' field), Integer (Integer numeric field),
Decimal (Numeric field with comma separated values), etc.;

When the field type is a reference to another Entity it means that in fact the current field is
expressing a relationship of the current Entity to the referenced Entity. We also say that the
current field is of Type of the referenced Entity (having in fact all the attributes of this
refered entity).
Expressing the link between the different entities is important in order to express the
multiplicity (how many entities of a type can relate to another one)

Example of a reference to another entity:

In the examples presented on the right, the Entity Person contains a field
personContactDetails which would have the Field Type : ContactDetails. This means that
the Person(entity) is related to the ContactDetails (entity) .

The number of Contact Details a Person can have (a person can have 0 or many Contact
Details) is expressed in the field 'Occurence'.

Field Sizes

XS : 120 characters;
S : 255 characters;
M : 500 characters;
L : 2000 characters;
XL : clob;
SRN : 15 characters;
Number (10);
Decimal : Numeric- comma separated values;
Table short names: VARCHAR 2 (3 CHAR);
Audit fields : VARCHAR2 (30 CHAR)

Can the user provide multiple translations for this field (if blank means No)
How many times does this field exists?
if the field will be used in the search (if blank means No)
if the information stored in this field is considered personal data in compliance with PDPR (if
blank means No)
if the information from this field will be available into the MDR Eudamed public site (if blank
means No)
mentions if the field is updateble when creating a normal update of the entity (standard
version) (if blank means No)
referance to the legal bases for the field when 'required in legislation' flag is 'Yes' (if blank
means No)
referance to the legal bases for the field when 'required in legislation' flag is 'Yes' (if blank
means No)
Data Exchange Entity name
Data Exchange XSD Element / Entity Attribute
class Generic_Link betw een Entities class Generic_Link betw een Entities

Person Person

- personName: String(Text) - personContactDetails: ContactDetails [0..*]

- personSurname: String(Text) - personName: String(Text)
- personAge: int(Numeric) - personSurname: String(Text)
- personAge: int(Numeric)

+personContactDetails 0..*

ContactDetails

- email: String(Text)
- phone: String(Text)
Entity
DIIdentifier

BasicUDIData

EUDIData

UDIData

UDIDeviceData

ARComment

Clink

DeviceCertificateInfor
mation

ContainedItem

DeviceStatus
ClinicalSize
SubstanceList

InstructionForUseDeta
ils

ProductDesignerLink

Organisation

GeographicAddress

PublicContactDetails

MarketInfo

SSCP

SSCP Document

VersionData
Manufacturer
NotfiedBody
AuthorisedRepresentati
ve
SystemOrProcedurePack
Provider
Description
Unique (Primary) Identifier for a Device, Device Model, Package Structure element or
Unit of Use;

Device identifier consists of the DI Code and Issuing Entity.

Basic UDI is the Device Model (grouping of Devices having similar properties) for a
Device. BasicUDIData manages the properties and relationships for a Device, from the
Device Model level;

EUDAMED DI is the Device Model (grouping of Devices having similar properties) for a
Legacy Device. EUDIData manages the properties and relationships for a Device, from
the Device Model level;

UDI-DI is the unique identificator of a Device (the device itself). UDIData entity manages
all the properties and relationships for a Device, from the Device level;

UDI-DI/ EUDAMED ID is the unique identificator of a Legacy Device (the device itself).
UDIDeviceData entity manages all the properties and relationships for a Legacy Device,
from the Device level;

Comments entered by Authorised Representatives for a Basic UDI-DI to which it is linked

When registering the Device - where applicable, the single identification number of the
clinical investigation or investigations conducted in relation to the device or a link to the
clinical investigation must be provided.

Entity stores a reference or the details to the Clinical Investigations linked to the Basic
UDI-DI

When registering the Device, for Devices covered by Product certificates, user will have
to provide identification details of the Product Certificate covering the Device.

Entity stores a reference to the Certificates Scopes linked to the Basic UDI-DI

Entity stores the main details of the Device (UDI-DI) and of Packaging Structure element.

Entity stores the status of the Device or Package element

When registering the 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, Precizion,
Value (either Range, single value or Text) and Measuring Unit

Device Clinical Size properties

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.

Entity stores the details of these Substances

Storage and handling Conditions and 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.

Entity stores the details for Critical Warnings and Storage and Handling Conditions

Details of the Natural or Legal Person who designed or Manufactured the Device

In case the Natural or Legal Person who designed or Manufactured the Device is not
registered in EUDAMED as a Manufacturer, the Organisation details of that entity.

In case the Natural or Legal Person who designed or Manufactured the Device is not
registered in EUDAMED as a Manufacturer, the Address details of that entity.

In case the Natural or Legal Person who designed or Manufactured the Device is not
registered in EUDAMED as a Manufacturer, the contact details of that entity.

Entity stores the details about the market distribution of the Device (Countries were the
device is placed on the market)
Entity stores the details about the Summary of Safety and Clinical Performance

Entity stores details about the details of the SSCP Attachement (document associated to
an SSCP)
Entity stores the details about the versions of the different entities
Entity stores the details about the Manufacturer Actor registered in EUDAMED
Entity stores the details about the Notified Body Actor registered in EUDAMED
Entity stores the details about the Authorised Representative Actor registered in
EUDAMED
Entity stores the details about the System or Procecure Pack Producer Actor registered in
EUDAMED
MDR Eudamed - Data Dictionary
EA
Field ID Field Label Entity Name

FLD-UDID-01 Issuing Entity Basic UDI-DI BasicUDIData

FLD-UDID-14 Basic UDI- DI BasicUDIData

FLD-UDID-10 Legal Manufacturer SRN BasicUDIData

FLD-UDID-11 Applicable Legislation BasicUDIData

FLD-UDID-12 Is it a System which is a BasicUDIData
Device in itself, Procedure
pack which is a Device in
itself or Kit

FLD-UDID-13 Special Device Type BasicUDIData

FLD-UDID-15 Authorised Representative BasicUDIData

FLD-UDID-16 Risk Class BasicUDIData

FLD-UDID-18 Tissues and cells - Presence BasicUDIData

of animal tissues or Cells, or
their derivates
FLD-UDID-20 Device Model BasicUDIData

FLD-UDID-22 Device Name BasicUDIData

FLD-UDID-23 Tissues and cells - presence BasicUDIData

of human tissues or cells, or
their derivates

FLD-UDID-28 Active Device BasicUDIData

FLD-UDID-29 Device Intended to BasicUDIData

administer and/or Remove
medicinal product
FLD-UDID-30 Implantable BasicUDIData

FLD-UDID-31 Measuring Function BasicUDIData

FLD-UDID-32 Reusable Surgical BasicUDIData

Instruments
FLD-UDID-33 Companion Diagnostic BasicUDIData

FLD-UDID-34 Tissues and cells - BasicUDIData

Presence of cells or
substances of microbial
origin
FLD-UDID-35 Near Patient Testing BasicUDIData

FLD-UDID-36 Patient Self Testing BasicUDIData

FLD-UDID-37 AR Comments BasicUDIData

FLD-UDID-155 Presence of a substance BasicUDIData

which , if used separately,
may be considered to be a
medicinal product derived
from human blood or
plasma

FLD-UDID-158 Presence of substance BasicUDIData

which, if used separately,
may be considered to be a
medicinal product

FLD-UDID-262 Reagent BasicUDIData

FLD-UDID-263 Professional Testing BasicUDIData

FLD-UDID-264 Instrument BasicUDIData

FLD-UDID-265 Is it Device a suture, BasicUDIData

staple, dental filling, dental
brace (...)?

FLD-UDID-50 Clinical Investigations BasicUDIData

associated to the Basic
UDI
FLD-UDID-39 Device Certificate BasicUDIData
Information associated to
the Device

FLD-UDID-40 Version BasicUDIData

FLD-UDID-51 Clinical Clink

Investigation/Performance
study reference Number

FLD-UDID-300 Countries outside EU were Clink

Clinical Investigation is
performed

FLD-UDID-54 version Clink

FLD-UDID-60 Certificate Type (Technical DeviceCertificateInf
Documentation, Type ormation
Examination, etc)

FLD-UDID-61 Certificate Number DeviceCertificateInf

ormation

FLD-UDID-62 Revision Number DeviceCertificateInf

ormation

FLD-UDID-63 Notified Body DeviceCertificateInf

ormation

FLD-UDID-66 N/A DeviceCertificateInf

ormation
FLD-UDID-67 N/A DeviceCertificateInf
ormation
EA EA
Field Description / Notes ENUM Reference Code Field Type

Assigned Issuing Entities that will ENUM_MDR_IssuingEntity Enum

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).

The Commission shall designate

one or several entities to operate
a system for assignment of UDIs
('issuing entity')

Device Identifier code/value (DI String

Code). Together with the Issuing
Entity creates the uniqness of the
element to which they are
assigned (Basic UDI-DI , UDI-DI,
etc.)

The Basic UDI-DI is the primary

identifier of a device model.It is
the main key for records in the
UDI database and is referenced
in relevant certificates and EU
declarations of conformity

SRN of the Manufacturer that Manufacturer

registers the Device.

Applicable Legislation of the ENUM_MDR_LEG Enum

Device.

The device can have only one

Applicable Legislation. Either a
Regulation value can be
selected/provided (MDR or IVDR)
or a Directive Regulation value
(MDD, AIMDD or IVDD) - in the
case of Directive Devices.
Property defines if the Basic UDI- ENUM_UDID_MultiComponentDevicEnum
DI is refering 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.

Property is a applicable for

Standard Devices (not Systems
or Procedure Packs)

Option Kit is only applicable in

case of IVDR Devices and
System which is a Device in
itself, Procedure pack which is a
Device in itself are applicable
only in case of MDR Devices

Property defines if the Device is ENUM_UDID_SpecialDevice Enum

a Special Device Type anf if so ,
the type of Special device Type.

In case the Device is a Standard

Device having the option System
or Procedure Pack (which is a
Device in itself) or a System or
Procedure Pack - field is not
supplied.

The SRN of the Authorised Authorised Representative

Representative associated with
the Basic UDI-DI.

For Manufacturers which are not

established in the Union (NonEU
Manufacturers) providing the
Authorised Representative for the
Basic UDI-DI is required.

Risk Class of the Device ENUM_UDID_RiskClass Enum

associated with the Basic UDI-DI.

Device Risk Class is dependent

directly on the Applicable
Legislation of the Device.

Property defines if the Device has Boolean

presence of animal tissues or
cells or their derivates
I nformation allowing the String
identification of the device -
Device Model.

At least one of the Device

identification details (Device
Model or the Device Name) have
to be provided for a Basic UDI-DI.

I nformation allowing the String

identification of the device -
Device Name.

At least one of the Device

identification details (Device
Model or the Device Name) have
to be provided for a Basic UDI-DI.

Property defines if the Device has Boolean

presence of human tissues or
cells or their derivates

Property defines if the Basic UDI- Boolean

DI corresponds to an Active
device or not.

'Active device' means 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.
Software shall also be deemed to
be an active device.

Property defines if the Device is Boolean

intended to administer or remove
medicinal product
Property defines if the Basic UDI- Boolean
DI corresponds to a device that is
Implantable or not.

Any device intended to be

partially introduced into the
human body by clinical
intervention and intended to
remain in place after the
procedure for at least 30 days
shall also be deemed to be an
implantable device

Property defines if the Device has Boolean

a Measuring Function or not

Property defines if the Device is Boolean

a Reusable Surgical Instrument
or not.

'Reusable surgical instrument'

means an instrument intended for
surgical use in cutting, drilling,
sawing, scratching, scraping,
clamping, retracting, clipping or
similar procedures, without a
connection to an active device
and which is intended by the
Manufacturer to be reused after
appropriate procedures such as
cleaning, disinfection and
sterilisation have been carried
out.
Property defines if the Device Boolean
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.

Property defines if the Device Boolean

contains presence of substances
of microbial origin

Property defines if the Device Boolean

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;

Property defines if the Device is Boolean

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;
References the comments made ARComment
by the Authorised Representative
in regards to a Device to which
they are assigned.

Defines if the Device containes Boolean

substances which may be
considered medicinal product
derived from human blood or
plasma

Defines if the Device containes Boolean

substances which may be
considered medicinal product

Property defines if the Device is a boolean

reagent or not.
Property defines if the Device is boolean
designed to be used for
Professional Testing or not.
Property defines if the Device is boolean
an Instrument or not.
Property defines if the registered boolean
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

References the Clinical Clink

Investigation Link, storing the
details of Clinical Investigations
associated to the Basic UDI-DI
References the Device Certificate DeviceCertificateInformatio
Informations related to the Basic n
UDI-DI.

When registering the Device ,

Device Certificate information is
required when the Regulation
Device is covered by a Product
Certificate (required to provide
the Notified Body and optional
Certificate Number and
Certificate Date)

Reference to the version of the VersionData

Basic UDI DI

When registering the Device - String

where applicable, the single
identification number of the
clinical investigation or
investigations conducted in
relation to the device or a link to
the clinical investigation must be
provided.

Field stores the Clinical

Investigation Number provided by
the user when the Clinical
Investigation is not registered in
EUDAMED

List of Countries were the Clinical ENUM_MDR_COUNTRY Enum

Investigation has been
performed.

Field is optional and can be

provided only for Clinical
Investigations performed Outside
EU (Non EU Countries only).

If provided, the Clinical

Investigation is considered to be
NonEU Clinical Investigation

Reference to the version of the VersionData

Link
When registering the Device, for ENUM_CRF_CertificateType Enum
Devices covered by Product
certificates, user will have to
provide identification details of
the Product Certificate covering
the Device.

Property defines the type of

Product Certificate associate with
the Device.

When registering the Device, for String

Devices covered by Product
certificates, user will have to
provide identification details of
the Product Certificate covering
the Device.

Property stores the Certificate

Number of the Product Certificate

When registering the Device, for String

Devices covered by Product
certificates, user will have to
provide identification details of
the Product Certificate covering
the Device.

Property stores the Certificate

Revision Number of the Product
Certificate

When registering the Device, for NotifiedBody

Devices covered by Product
certificates, user will have to
provide identification details of
the Product Certificate covering
the Device.

Property stores the reference to

the Notified Body that issued the
Product Certificate

Reference to a Decision of the Decision

Notified Body regarding the
linking of a Device to a Certificate
(Validation of the link)
Reference to the version of the VersionData
Link
Field Size Multilingual Occurrence Searchable GDPR Public Access
Flag Flag Flag

1 Y Y

XS

1 Y Y

SRN

1 Y Y

1 Y Y
 0..1 Y

0..1 Y Y

SRN

0..1 (Applicable
only for nonEU Y Y
MF)

1 Y Y

1 Y Y
XS

0..1 (Either
Device Model or
Y Y
Device Name is
required)

XS

0..1 (Either
Device Model or
Y Y
Device Name is
required)

1 Y Y

1 Y Y

1 Y Y
1 Y Y

1 Y Y

1 Y Y
1 Y Y

1 Y Y

1 Y Y

1 Y Y
 0..n

1 Y Y

1 Y Y

1 Y Y

1 Y Y

1 Y Y

0..1 (Property is
applicable only
for Devices
having Risk Class
Y Y
II b and having
the property
'Implantable'
marked)

0..n Y
0..n

1 Y

1 Y

0..n Y

1
 1 Y

XS

0..1 Y

XS

0..1 Y

1 Y

0..1
1 Y
Updateable Field Applicable Field DTX Entity
for MDR Applicable
for IVDR

Y Y DIIdentififierType

Y Y DIIdentififierType

DeviceBasicUDIType

Y Y

Y Y Either MDRBasicUDIType
or
IVDRBasicUDIType
submitted in order to
define the Applicable
Legislation
 MDRBasicUDIType

IVDRBasicUDIType

Y Y

MDRBasicUDIType

IVDRBasicUDIType

Y Y

DeviceBasicUDIType

Y Y Y

BasicUDIType

Y Y

DeviceBasicUDIType

Y Y
 ModelNameGroup

Y Y Y

ModelNameGroup

Y Y Y

DeviceBasicUDIType

Y Y

MDRApplicableProperti
esGroup

MDRApplicableProperti
esGroup
Y
 MDRApplicableProperti
esGroup

MDRApplicableProperti
Y esGroup

MDRApplicableProperti
esGroup

Y
 IVDRApplicableProperti
esGroup

IVDRBasicUDIType
Y

IVDRApplicableProperti
esGroup

IVDRApplicableProperti
esGroup

Y
 Y Y

MDRBasicUDIType

MDRBasicUDIType

IVDRApplicableProperti
Y esGroup
IVDRApplicableProperti
Y esGroup

IVDRApplicableProperti
Y esGroup
MDRBasicUDIType

Y Y Y
Y Y

Y Y

ClinialInvestigationLinkT
ype

Y Y

ClinicalInvestigationLink
Type

Y Y

Y Y
 CertificateLinkType

Y Y

CertificateLinkType.Cert
ificate
(CertificateIdentifierLink
Type)

Y Y

CertificateLinkType.Cert
ificate
(CertificateIdentifierLink
Type)

Y Y

Y Y

Y Y
Y Y
XSD Element Name

issuingEntityCode

DICode

MFActorCode
type
IVDApplicablePropertie
sGroup (for KIT)

specialDevice

ARActorCode

riskClass

animalTissuesCells
model

name

humanTissuesCells

active

administeringMedicine
implantable

measuringFunction

reusable
companionDiagnostics

microbialSubstances

nearPatientTesting

selfTesting
humanProductCheck

medicinalProductCheck

reagent

professionalTesting

instrument

IIb_implantable_excepti
ons
clinicalInvestigationRefe
rence

nonEUApplicableCountr
ies
certificateType

certificateNumber

certificateRevisionNum
ber
MDR Eudamed - Data Dictionary
EA EA
Field ID Field Label Entity Name Field Description /
Notes

FLD-UDID-80 N/A 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.

Field stores the Date

when the decision to
validate the link of
Certificate with Device
has been taken

FLD-UDID-82 N/A 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.

Field stores the type of

Decision taken .

Value that can be taken

is 'Approved'
FLD-UDID-84 N/A 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.

Field stores the

reference to the Notified
Body who took the
Decision to validate the
link off Certificate with
the Device.

FLD-UDID-112 Basic UDI-DI for which SSCP SSCP(Summary of safety

the SSCP is uploaded and clinical performance)
can be registered in
EUDAMED by the Notified
Body and can be
periodically updated

Field stores the reference

to the Basic UDI - DI for
which the SSCP is
uploaded

FLD-UDID-113 Notified Body SSCP SSCP(Summary of safety

and clinical performance)
can be registered in
EUDAMED by the Notified
Body and can be
periodically updated

Field stores the reference

to the Notified Body who
uploaded the SSCP
FLD-UDID-115 Attachement SSCP SSCP(Summary of safety
and clinical performance)
can be registered in
EUDAMED by the Notified
Body and can be
periodically updated

Field stores a reference to

a Document uploaded in
EUDAMED

FLD-UDID-307 Notified Body SSCP SSCP Reference of the SSCP

Reference provided by the NB
FLD-UDID-288 Version SSCP Version of the SSCP
FLD-UDID-270 Master Document SSCPDocument SSCP(Summary of
safety and clinical
performance) can be
registered in EUDAMED
by the Notified Body and
can be periodically
updated

Field marks the fact that

the current document is
the SSCP master
attachement (validated
by the NB)

FLD-UDID-289 Validated SSCPDocument Field marks the fact that

the document has been
validated by the NB

FLD-UDID-308 SSCP Type SSCPDocument Type of the SSCP

document (Patient/Lay
Person or Healthcare
Professional)
FLD-UDID-301 SSCP Document SSCPDocument Document associated to
the SSCP.

The document is in a
specific language.

FLD-UDID-290 Version SSCPDocument Version of the SSCP

Document
 EA
ENUM Reference Code Field Type Field Multilingual Occurrence
Size Flag

date

ENUM_UDID_DecisionTaken enum
( only Approved value
accepted)

1
NotifiedBody

Basic UDI data

NotifiedBody Code

1
 SSCPDocument

1..n

String
S 1

VersionData
Boolean

Boolean
1

ENUM_UDID_SSCPType Enum
1

StoredDocument

VersionData
1
Searchable GDPR Flag Public Updateable DTX Entity
Access Flag

NBCertificateLinkDecisionType

NBCertificateLinkDecisionType

Y
 NBCertificateLinkDecisionType

SSCPType

Y Y Y

SSCPType

Y Y Y
 SSCPType

Y Y

SSCPType
Y

Y
SSCPDocumentType

SSCPDocumentType
Y

SSCPDocumentType
Y

Y
XSD Element Name

date

reason
ownerActorCode

basicUDI

NBActorCode
documents

NBInternalReferenceCo
de

masterDocument

status

type
MDR Eudamed - Data Dictionary
EA
Field ID Field Label Entity Name

FLD-UDID-137 Member State of the placing UDIData

on the EU market of the
device

FLD-UDID-130 Device Status UDIData

FLD-UDID-324 Status Date UDIData

FLD-UDID-256 Device Substatus UDIData

FLD-UDID-131 Device SubStatus DeviceSubstatus

FLD-UDID-252 Member State were the MarketInfo

device is or is to be made
available
EA EA
Field Description / Notes ENUM Reference Field Type Field
Code Size

Defines the Country were the ENUM_MDR_COUNTR Enum

device has been placed on the Y
Market (Member State in which
the device is to or has been
placed on the market in the
Union)

Status of the Device (On the ENUM_UDID_Devic Enum

market, No longer placed on the eStatus
market).
Date from which the current Date
Status applies.

When performing updates on

the Device from the UI, value of
the field will be set up
automatically.

Stores a references to the DeviceSubstatus

Substatus of the Device
SubStatus of the Device ENUM_UDID_Devic Enum
(Recalled, Field safety eSubStatus
corrective action initiated)
Details regarding the Countries Enum
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

ENUM_MDR_COUNTR
Y
Multilingual Occurrence Searchable GDPR Public Updateable
Flag Flag Access
Flag

0..1 (0 only if
Device Status is
Y Y
‘not intended for
EU market’”; )

1 Y Y

0..1 Y

0..1 Y Y

1 Y Y Y

1 Y Y
Field Field DTX Entity XSD Element Name
Applicable for Applicable for
MDR IVDR

country (having property

Y Y MarketInfoType originalPlacedOnTheMark
et True)

Y Y UDIDIStatusType code

Y Y UDIDIStatusType date

Y Y

Y Y UDIDISubstatusType code

Y Y MarketInfoType country
MDR Eudamed - Data Dictionary
EA
Field ID Field Label Entity Name

FLD-UDID-295 Issuing Entity for EUDIData

EUDAMED DI

FLD-UDID-42 EUDAMED DI EUDIData

FLD-UDID-10 Legal Manufacturer SRN EUDIData

FLD-UDID-11 Applicable Legislation EUDIData

FLD-UDID-12 Is it a System which is a EUDIData
Device in itself, Procedure
pack which is a Device in
itself or Kit

FLD-UDID-13 Special Device Type EUDIData

FLD-UDID-15 Authorised Representative EUDIData

FLD-UDID-16 Risk Class EUDIData

FLD-UDID-18 Tissues and cells - Presence EUDIData

of animal tissues or Cells, or
their derivates
FLD-UDID-20 Device Model EUDIData

FLD-UDID-22 Device Name EUDIData

FLD-UDID-23 Tissues and cells - presence EUDIData

of human tissues or cells, or
their derivates

FLD-UDID-28 Active Device EUDIData

FLD-UDID-29 Device Intended to EUDIData

administer and/or Remove
medicinal product
FLD-UDID-30 Implantable EUDIData

FLD-UDID-31 Measuring Function EUDIData

FLD-UDID-32 Reusable Surgical EUDIData

Instruments
FLD-UDID-33 Companion Diagnostic EUDIData

FLD-UDID-34 Tissues and cells - EUDIData

Presence of cells or
substances of microbial
origin
FLD-UDID-35 Near Patient Testing EUDIData

FLD-UDID-36 Patient Self Testing EUDIData

FLD-UDID-262 Reagent EUDIData

FLD-UDID-263 Professional Testing EUDIData

FLD-UDID-264 Instrument EUDIData

FLD-UDID-50 Clinical Investigations EUDIData

associated to the
EUDAMED DI

FLD-UDID-39 Device Certificate EUDIData

Information associated to
the Device

FLD-UDID-37 N/A EUDIData

FLD-UDID-51 Clinical Clink

Investigation/Performance
study reference Number

FLD-UDID-54 Version Clink

FLD-UDID-300 Countries outside EU were Clink
Clinical Investigation is
performed

FLD-UDID-60 Certificate Type DeviceCertificateInf

ormation

FLD-UDID-61 Certificate Number DeviceCertificateInf

ormation
FLD-UDID-62 Revision Number DeviceCertificateInf
ormation

FLD-UDID-63 Notified Body DeviceCertificateInf

ormation

FLD-UDID-64 Expiry Date DeviceCertificateInf

ormation
FLD-UDID-291 Issuing Entity UDI-DI / UDIDeviceData
EUDAMED ID

FLD-UDID-178 UDI-DI / EUDAMED ID UDIDeviceData

FLD-UDID-137 Member State of the UDIDeviceData

placing on the EU market
of the device

FLD-UDID-139 Natural or Legal person UDIDeviceData

who manufactured and
desinged the Device
FLD-UDID-311 List of Medicinal product UDIDeviceData
substances associated to
the Device

FLD-UDID-141 Countries were the devices is UDIDeviceData

made available

FLD-UDID-144 List of Critical Warnings or UDIDeviceData

Contraindications or
Storage and handling
Conditions

FLD-UDID-312 List of Storage and UDIDeviceData

handling Conditions

FLD-UDID-145 EUDAMED DI Identifier UDIDeviceData

FLD-UDID-146 Clinical Sizes UDIDeviceData

FLD-UDID-149 Nomenclature code UDIDeviceData

FLD-UDID-156 Containing latex UDIDeviceData

FLD-UDID-157 Maximum number of UDIDeviceData
reuses

FLD-UDID-163 Reference / Catalogue UDIDeviceData

Number

FLD-UDID-164 Reprocessesed single use UDIDeviceData

device

FLD-UDID-167 Labelled as single use UDIDeviceData

FLD-UDID-169 Device labelled sterile UDIDeviceData

FLD-UDID-170 Need for sterilisation UDIDeviceData

before use
FLD-UDID-174 URL for additional UDIDeviceData
information

FLD-UDID-175 Additional product UDIDeviceData

Description

FLD-UDID-176 Name/ Trade name UDIDeviceData

FLD-UDID-130 Device Status UDIDeviceData

FLD-UDID-324 Status Date UDIDeviceData

FLD-UDID-256 Device Substatus UDIDeviceData

FLD-UDID-180 Related UDI-DI UDIDeviceData

FLD-UDID-181 Relationship Type UDIDeviceData

FLD-UDID-177 Version UDIDeviceData

FLD-UDID-131 Device SubStatus DeviceSubStatus

FLD-UDID-122 Recall Precision DeviceSubStatus

FLD-UDID-123 Scope of Recall DeviceSubStatus

FLD-UDID-126 Start date DeviceSubStatus

FLD-UDID-127 End date DeviceSubStatus

FLD-UDID-190 /Clinical Size Type ClinicalSize

FLD-UDID-191 /Precizion ClinicalSize

FLD-UDID-192 /Maximum ClinicalSize

FLD-UDID-193 /Value(Minimum) ClinicalSize

FLD-UDID-194 /Value(Text) ClinicalSize

FLD-UDID-195 /Measure Unit ClinicalSize

FLD-UDID-316 Type of Substance (Presence MedicinalProductS

of a substance which, if used ubstance
separately, may be (SubstanceList)
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)
FLD-UDID-317 Name of Substance MedicinalProductS
ubstance
(SubstanceList)

FLD-UDID-318 INN MedicinalProductS

ubstance
(SubstanceList)
FLD-UDID-211 Storage/handling conditions Storage and
type Handling
(ConditionForUse)

FLD-UDID-213 Storage/Handling conditions Storage and

Description Handling
(ConditionForUse)

FLD-UDID-212 Critical Warnings type Critical Warnings

(ConditionForUse)
FLD-UDID-221 Enter the SRN (Is the Device ProductDesignerLi
designed or Manufactured nk
by another legal or natural
person)

FLD-UDID-222 ProductDesignerLi
nk

FLD-UDID-223 version ProductDesignerLi

nk
FLD-UDID-225 Name Organisation

FLD-UDID-226 N/A Organisation

FLD-UDID-227 N/A Organisation

FLD-UDID-230 Street GeographicAddres

s

FLD-UDID-231 Street number GeographicAddres

s
FLD-UDID-232 Address complement GeographicAddres
s

FLD-UDID-233 PO box GeographicAddres

s

FLD-UDID-234 City name GeographicAddres

s

FLD-UDID-235 Postal code GeographicAddres

s
FLD-UDID-236 Country GeographicAddres
s

FLD-UDID-240 Telephone PublicContactDetai

ls

FLD-UDID-241 Email PublicContactDetai

ls

FLD-UDID-250 Start date MarketInfo

FLD-UDID-251 End date MarketInfo

FLD-UDID-252 Member State were the MarketInfo

device is or is to be made
available

FLD-UDID-246 Version MarketInfo

EA EA
Field Description / Notes ENUM Reference Code Field Type

Assigned Issuing Entities that will ENUM_MDR_IssuingEntity. Enum

generate the DI Codes allocated In case of EUDAMED DI- Issuing
for all DI`s inside Eudamed Entity is by default EUDAMED

String
The EUDAMED DI is the primary
identifier of a device model for a
Legacy Device.

EUDAMED DI can be provided

by the Manufacturer based on
previously defined algorithm or
can be automatically generated
based on the UDI-DI if this is
provided for the current Legacy
Device.

SRN of the Manufacturer that Manufacturer

registers the Device.

Applicable Legislation of the ENUM_MDR_LEG Enum

Device.

The device can have only one

Applicable Legislation. Either a
Regulation value can be
selected/provided (MDR or IVDR)
or a Directive Regulation value
(MDD, AIMDD or IVDD) - in the
case of Directive Devices.
Property defines if the Basic UDI- ENUM_UDID_MultiComponentDevicEnum
DI is refering 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.

Property is a applicable for

Standard Devices (not Systems
or Procedure Packs)

Property defines if the Device is ENUM_UDID_SpecialDevice Enum

a Special Device Type anf if so ,
the type of Special device Type.

In case the Device is a Standard

Device having the option System
or Procedure Pack (which is a
Device in itself) or a System or
Procedure Pack - field is not
supplied.

The SRN of the Authorised Authorised Representative

Representative associated with
the Basic UDI-DI.

For Manufacturers which are not

established in the Union (NonEU
Manufacturers) providing the
Authorised Representative for the
Basic UDI-DI is required.

Risk Class of the Device ENUM_UDID_RiskClass Enum

associated with the Basic UDI-DI.

Device Risk Class is dependent

directly on the Applicable
Legislation of the Device.

Property defines if the Device has Boolean

presence of animal tissues or
cells or their derivates
I nformation allowing the String
identification of the device -
Device Model.

At least one of the Device

identification details (Device
Model or the Device Name) have
to be provided for a EUDAMED
DI.

Information allowing the String

identification of the device -
Device Name.

At least one of the Device

identification details (Device
Model or the Device Name) have
to be provided for a EUDAMED
DI.

Property defines if the Device has Boolean

presence of human tissues or
cells or their derivates

Property defines if the Boolean

EUDAMED DI corresponds to an
Active device or not.

'Active device' means 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.
Software shall also be deemed to
be an active device.

Property defines if the Device is Boolean

intended to administer or remove
medicinal product
Property defines if the Boolean
EUDAMED DI corresponds to a
device that is Implantable or not.

Any device intended to be

partially introduced into the
human body by clinical
intervention and intended to
remain in place after the
procedure for at least 30 days
shall also be deemed to be an
implantable device

Property defines if the Device has Boolean

a Measuring Function or not

Property defines if the Device is Boolean

a Reusable Surgical Instrument
or not.

'Reusable surgical instrument'

means an instrument intended for
surgical use in cutting, drilling,
sawing, scratching, scraping,
clamping, retracting, clipping or
similar procedures, without a
connection to an active device
and which is intended by the
Manufacturer to be reused after
appropriate procedures such as
cleaning, disinfection and
sterilisation have been carried
out.
Property defines if the Device Boolean
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.

Property defines if the Device Boolean

contains presence of substances
of microbial origin

Property defines if the Device Boolean

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;

Property defines if the Device is Boolean

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;
Property defines if the Device is a boolean
reagent or not.
Property defines if the Device is boolean
designed to be used for
Professional Testing or not.
Property defines if the Device is boolean
an Instrument or not.
References the Clinical Clink
Investigation Link, storing the
details of Clinical Investigations
associated to the EUDAMED DI

References the Device Certificate DeviceCertificateInformatio

Informations related to the Basic n
UDI-DI

References the comments made ARComment

by the Authorised Representative
in regards to a Device to which
they are assigned.

When registering the Device - String

where applicable, the single
identification number of the
clinical investigation or
investigations conducted in
relation to the device or a link to
the clinical investigation must be
provided.

Field stores the Clinical

Investigation Number provided by
the user when the Clinical
Investigation is not registered in
EUDAMED

Reference to the version of the VersionData

Link
List of Countries were the Clinical ENUM_MDR_COUNTRY Enum
Investigation has been
performed.

Field is optional and can be

provided only for Clinical
Investigations performed Outside
EU (Non EU Countries only).

If provided, the Clinical

Investigation is considered to be
NonEU Clinical Investigation

When registering the Device, for ENUM_CRF_CertificateType Enum

Devices covered by Product
certificates, user will have to
provide identification details of
the Product Certificate covering
the Device.

Property defines the type of

Product Certificate associate with
the Device.

In case of Legacy Devices,

identification information about
Directive Certificates covering the
Devices is required to be
provided

When registering the Device, for String

Devices covered by Product
certificates, user will have to
provide identification details of
the Product Certificate covering
the Device.

Property stores the Certificate

Number of the Product
Certificate.

In case of Legacy Devices,

identification information about
Directive Certificates covering the
Devices is required to be
provided
When registering the Device, for String
Devices covered by Product
certificates, user will have to
provide identification details of
the Product Certificate covering
the Device.

Property stores the Certificate

Revision Number of the Product
Certificate.

When registering the Device, for NotifiedBody

Devices covered by Product
certificates, user will have to
provide identification details of
the Product Certificate covering
the Device.

Property stores the reference to

the Notified Body that issued the
Product Certificate.

In case of Legacy Devices,

identification information about
Directive Certificates covering the
Devices is required to be
provided

When registering the Device, for Date

Devices covered by Product
certificates, user will have to
provide identification details of
the Product Certificate covering
the Device.

Property stores the Certificate

Expiry Date of the Product
Certificate.

In case of Legacy Devices,

identification information about
Directive Certificates covering the
Devices is required to be
provided
Assigned Issuing Entities that will ENUM_UDID_IssuingEntity Enum
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).

The Commission shall designate

one or several entities to operate
a system for assignment of UDIs
('issuing entity')

Issuing Entity for the EUDAMED

ID is by default EUDAMED

The UDI-DI is a unique numeric String

or alphanumeric code specific to
a device and that is also used as
the 'access key' to information
stored in a UDI database.

The EUDAMED ID is the primary

identifier of device for a Legacy
Device.

A Legacy Device can have as

identifier for the Device - either a
UDI-DI or (in case an UDI-DI is
not assigned) a EUDAMED ID.

The EUDAMED ID is generated

automatically based on the
EUDAMED DI (when UDI-DI is
not provided)

Defines the Country were the ENUM_MDR_COUNTRY Enum

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)

Reference to the natural or Legal ProductDesignerLink

person who Designed and
Manufactured the device (in case
the Device is designed and
manufactured by another legal or
natural person)
References to the Medicinal MedicinalProductSubstance
product Substances associated (SubstanceList)
to the device

Reference to the list of Countries MarketInfo

were the device has been made
available
References the Critical warnings Critical Warnings
or Storage and Handling (ConditionForUse)
Conditions associated to Device
( list of Critical warnings or
Storage and Handling Conditions
associated to the UDI-DI).

References the Storage and Storage and Handling

Handling Conditions associated (ConditionsForUse)
to the Device (UDI-DI)

Reference to the EUDAMED DI EUDIData

to which the Device is
associated.

References to the list of Clinical ClinicalSize

Sizes associated to the UDI-DI

The Device Nomenclature ENUM_UDID_MDN Enum

Code(s) associated with the UDI-
DI.
The corresponding CND
Nomenclature Code will be
stored in the field

Property defines if the Device Boolean

contains latex into it`s
composition
Property defines the Maximum Number
Number of reuses applicable for
the Device.

Field is optional and can be

completed if the Device is not
marked as single use device
( singleUse is false).

Property stores the Reference or String

Catalogue Number of the Device

Property defines if the Device is a Boolean

Reprocessesed single use device
or not
Property defines if the Device is a Boolean
Labelled as a Single use or not

Property defines if the UDI-DI is Boolean

labeled as Sterile or not
Property defines if the UDI-DI Boolean
needs to be sterilised before use
or not
Manufacturer`s website where String
additional information about the
device (UDI-DI) are available

Additional Product Description. LanguageSpecificContent

Additional Product Description is

required for System or Procedure
Packs or for Standard Devices
being marked as System or
Procedure Packs (as a Device in
themselvs)

Device Trade Name assigned to LanguageSpecificContent

the UDI-DI

Trade names can be provided if

applicable for the device. Several
Trade- Names can be provided
for the Device in the same
language or in different
languages.

Status of the Device (On the ENUM_UDID_DeviceStatus Enum

market, No longer placed on the
market).
Date from which the current Date
Status applies.

When performing updates on the

Device from the UI, value of the
field will be set up automatically.

Stores a references to the DeviceSubstatus

Substatus of the Device
UDI-DI related to the current UDI- UDIData
DI / EUDAMED ID.

The reference will be used in

order 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
Type of Relationship created ENUM ENUM_Device_Link_Relati
between Devices (UDI-DI`s). onship_Type (for the
moment the only
The relationships between the relationship accepted is
different Devices (UDI-DI`s) can 'Legacy-Regulation Device
be of several types (defining the Link')
business context that implied
creating the relationship between
these Devices)

Reference to the version of the VersionData

Device

SubStatus of the Device ENUM_UDID_DeviceSubStatus Enum

(Recalled, Field safety corrective
action initiated)
When the Status of a Device is LanguageSpecificContent
set to FSCA Initiated or Recall,
details about the Scope of the
Recall/ FSCA are required
(description of the serialnumber /
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)

When the Status of a Device is ENUM_UDID_DeviceScope Enum

set to FSCA Initiated or Recall,
details about the Scope of the
Recall/ FSCA are required
(description of the serialnumber /
lot number, etc.)

Field defines how the Scope of

the Recall is defined (by Lot
number, Serial Number , etc.)

Start Date when the Substatus Date

has been initialised
End Date when the Substatus Date
has been closed (Triggered by
Vigilance module)
Device Clinical Sizes can be ENUM_UDID_ClinicalSizeType Enum
provided if applicable. Several
Clinical Sizes can be added for
the Device. Clinical Size will be
defined by the Type, Precizion,
Value (either Range, single value
or Text) and Measuring Unit

The Type of Clinical Size

(example : length, width, etc.)

Device Clinical Sizes can be ENUM_UDID_ClinicalSizePrecisio Enum

provided if applicable. Several n
Clinical Sizes can be added for
the Device. Clinical Size will be
defined by the Type, Precizion,
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
Other is selected)

Device Clinical Sizes can be Decimal

provided if applicable. Several
Clinical Sizes can be added for
the Device. Clinical Size will be
defined by the Type, Precizion,
Value (either Range, single value
or Text) and Measuring Unit

Maximum Value that the Clinical

Size can get (when Range is
selected as precision)

Device Clinical Sizes can be Decimal

provided if applicable. Several
Clinical Sizes can be added for
the Device. Clinical Size will be
defined by the Type, Precizion,
Value (either Range, single value
or Text) and Measuring Unit

Value (Minimum) that the Clinical

Size can get (when Value or
Range is selected as precision)
Device Clinical Sizes can be String
provided if applicable. Several
Clinical Sizes can be added for
the Device. Clinical Size will be
defined by the Type, Precizion,
Value (either Range, single value
or Text) and Measuring Unit

Value that the Clinical Size can

get (when Other is selected as
precision)

Device Clinical Sizes can be ENUM_UDID_ClinicalSizeMeasure Enum

provided if applicable. Several Unit
Clinical Sizes can be added for
the Device. Clinical Size will be
defined by the Type, Precizion,
Value (either Range, single value
or Text) and Measuring Unit

Clinical Size Measure Unit

Field stores the details regarding ENUM_UDID_SubstType Enum

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)
When registering a new Device LanguageSpecificContent
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 is provided,
field is no longer required

Field stores the INN value for the String

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.
Storage and handling Conditions ENUM_UDID_StorageHandlingCo Enum
specified on the Label of the ndition
Device or in the Instruction of
Use have to be registered in
EUDAMED - if applicable.

Field stores the Type of Storage

and Handling Conditions. Field is
Applicable only when the type of
Conditions for Use have the Type
Storage / handling Conditions,
being required in this case.

Comments or description LanguageSpecificContent

associated to the values selected
form the Storage or handling
Conditions or Critical warnings

Storage and handling Conditions ENUM_UDID_CriticalWarnings Enum

and 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.
Details of the Product Designer String
(Original Manufacturer) who
Manufactured (produced) or
Designed the Device.

An original design manufacturer

(ODM) is a company that designs
and manufactures a product, as
specified, that is eventually
rebranded by another firm for
sale.

Details of the Product Designer

can be given either by providing
the SRN (if the PD is already
registered in EUDAMED and has
an SRN) or by providing
Organisation details (Name and
Contact Details - in case the PD
is not registered in EUDAMED)

SRN of the natural or legal

person who designed and
manufactured the device.
Reference to a Manufacturer
present in EUDAMED

Details of the Product Designer Organisation

(Original Manufacturer) who
Manufactured (produced) or
Designed the Device.

Reference to an Organisation
details provided in case the
Manufacturer that designed and
manufactured the device is not
present in EUDAMED.

Reference to the version of the VersionData

Link
Details of the Product Designer
(Original Manufacturer) who
Manufactured (produced) or
Designed the Device.

Field stores the Name of the

Organisation (Manufacturer) that
designed and manufactured the
Device (UDI-DI).

Required in case the PD

Organisation link is provided
(ProductDesignerLink relates to
an Organisation)

Reference to a Georgrafic GeographicAddress

Address associated to the
Organisation

Reference to a set of Contact PublicContactDetails

Details stored for the organisation

Details of the Product Designer String

(Original Manufacturer) who
Manufactured (produced) or
Designed the Device.

Field stores the Street Name

Required in case the PD

Organisation link is provided
(ProductDesignerLink relates to
an Organisation)

Details of the Product Designer String

(Original Manufacturer) who
Manufactured (produced) or
Designed the Device.

Field stores the Street Number

Required in case the PD

Organisation link is provided
(ProductDesignerLink relates to
an Organisation)
Details of the Product Designer String
(Original Manufacturer) who
Manufactured (produced) or
Designed the Device.

Field stores the Complement of

the Address (Additional adress
details)

Required in case the PD

Organisation link is provided
(ProductDesignerLink relates to
an Organisation)

Details of the Product Designer String

(Original Manufacturer) who
Manufactured (produced) or
Designed the Device.

Field stores the POBox

Required in case the PD

Organisation link is provided
(ProductDesignerLink relates to
an Organisation)

Details of the Product Designer String

(Original Manufacturer) who
Manufactured (produced) or
Designed the Device.

Field stores the City name

Required in case the PD

Organisation link is provided
(ProductDesignerLink relates to
an Organisation)

Details of the Product Designer String

(Original Manufacturer) who
Manufactured (produced) or
Designed the Device.

Field stores the Postal code

Required in case the PD

Organisation link is provided
(ProductDesignerLink relates to
an Organisation)
Details of the Product Designer Enum
(Original Manufacturer) who
Manufactured (produced) or
Designed the Device.

Field stores the Country

Required in case the PD

Organisation link is provided
(ProductDesignerLink relates to
an Organisation)

ENUM_MDR_COUNTRY
Details of the Product Designer String
(Original Manufacturer) who
Manufactured (produced) or
Designed the Device.

Field stores the Phone Number of

the Company

Required in case the PD

Organisation link is provided
(ProductDesignerLink relates to
an Organisation)

Details of the Product Designer String

(Original Manufacturer) who
Manufactured (produced) or
Designed the Device.

Field stores the Email of the

Company

Required in case the PD

Organisation link is provided
(ProductDesignerLink relates to
an Organisation)

Details regarding the Countries Date

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
Details regarding the Countries Date
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

End Date when the Device is
made available on the marked

Details regarding the Countries Enum

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

ENUM_MDR_COUNTRY
Reference to the version of the VersionData
Market Info
Field Size Multilingual Occurrence Searchable GDPR Flag Public Access
Flag Flag

1 Y Y

XS

1 Y Y

SRN

1 Y Y

1 Y Y
 1 Y

0..1 Y Y

SRN

0..1 (Applicable
only for nonEU Y Y
MF)

1 Y Y

1 Y Y
XS

0..1 (Either
Device Model or
Y Y
Device Name is
required)

XS

0..1 (Either
Device Model or
Y Y
Device Name is
required)

1 Y Y

1 Y Y

1 Y Y
1 Y Y

1 Y Y

1 Y Y
1 Y Y

1 Y Y

1 Y Y

1 Y Y
 1 Y Y

1 Y Y

1 Y Y

0..n

0..n

0..n

1 Y
 0..n Y

1 Y

XS

1 Y
XS

0..1 Y

1 Y

1 Y
 1 (Either UDI-DI
or EUDAMED ID Y Y
is required))

XS

1 (Either UDI-DI
or EUDAMED ID Y Y
is required))

1 Y Y

0..1 Y
0..n Y

0..n Y

0..n Y

0..n Y

1 Y

0..n Y

1..n Y Y

1 Y Y
 0..1 (Field can be
completed only if
Y
singleUse is
false)

XS
1 Y Y

1 Y Y

1 Y Y

1 Y Y

1 Y Y
M
0..1 Y

0..1 (Required for

System or
Y Procedure Packs Y
that is a Device
in itself)

Y 0..n Y Y

1 Y

0..1 Y

0..1 Y

0..1 Y
 0..1 (Required
when Related
Y
Legacy Device is
provided )

1 Y

1 Y

Y 1 Y

1 Y

1 Y

0..1 Y
 1 Y

1 Y

0..1 Y

0..1 (Required
when Precision
Y
has value Range
or Value)
S

0..1 (Required
when Precision Y
has value Text)

0..1 (Required
when the
Precision value is Y
either Value or
Range)

1 Y
L

0..1 (Not required

Y in case the INN Y
is provided)

0..1 Y
 1 Y

L
0..n (Required for
specific items
from the list of
Y Enumerations- Y
were additional
details are
required)

1 Y
SRN

1 if SRN
Y
otherwise 0

0 if SRN
Y
otherwise 1

1 Y
 1 Y

0..1 Y

0..1 Y

1 Y

XS

0..1 Y
S

0..1 Y

XS

0..1 Y

XS

1 Y

XS

1 Y
 1 Y

XS

0..1 Y

XS

0..1 Y

1 Y
0..1 Y

1..n Y

1 Y
Updateable Field Applicable Field DTX Entity
for MDD/AIMDD Applicable
for IVDD

DIIdentififierType

Y Y

DIIdentififierType

Y Y

DeviceBasicUDIType

Y Y

MDRBasicUDIType
IVDRBasicUDIType

Y Y
 MDRApplicableProperti
esType

Y Y

MDRBasicUDIType

IVDRBasicUDIType

Y Y

DeviceBasicUDIType

Y Y Y

BasicUDIType

Y Y

DeviceBasicUDIType

Y Y
 ModelNameGroup

Y Y Y

ModelNameGroup

Y Y Y

DeviceBasicUDIType

Y Y

MDRApplicableProperti
esGroup

MDRApplicableProperti
esGroup
Y
 MDRApplicableProperti
esGroup

MDRApplicableProperti
Y esGroup

MDRApplicableProperti
esGroup

Y
 IVDRApplicableProperti
esGroup

IVDRBasicUDIType
Y

IVDRApplicableProperti
esGroup

IVDRApplicableProperti
esGroup

Y
 IVDRApplicableProperti
Y esGroup
IVDRApplicableProperti
Y esGroup

IVDRApplicableProperti
Y esGroup

Y Y

Y Y

Y Y

ClinicalInvestigationLink
Type

Y Y

Y Y
 ClinicalInvestigationLink
Type

Y Y

CertificateLinkType

Y Y

CertificateLinkType.Cert
ificate
(CertificateIdentifierLink
Type)

Y Y
 CertificateLinkType.Cert
ificate
(CertificateIdentifierLink
Type)

Y Y

CertificateLinkType.Cert
ificate
(CertificateIdentifierLink
Type)

Y Y

CertificateLinkType

Y Y
Y Y DIIdentififierType

Y Y UDIDIType

Y Y MarketInfoType

Y Y
 Y

Y Y

Y Y

Y Y UDIDIDataType

Y Y Y UDIDIDataType

Y MDRUDIDIDataType
Y Y DeviceUDIDIDataType

Y Y UDIDIDataType

Y MDRUDIDIDataType

Y Y DeviceUDIDIDataType

Y Y UDIDIDataType

Y Y UDIDIDataType
Y Y Y UDIDIDataType

Y Y Y UDIDIDataType

Y Y Y UDIDIDataType

Y Y Y UDIDIStatusType

Y Y UDIDIStatusType

Y Y Y

Y Y Y DeviceRelatedLinkType
 Y Y DeviceRelatedLinkType

Y Y

Y Y UDIDISubstatusType

Y Y UDIDISubstatusType

Y Y UDIDISubstatusType

Y Y Y UDIDISubstatusType

Y Y Y UDIDISubstatusType
Y ClinicalSizeType

RangeClinicalSizeType
Y
ValueClinicalSizeType

Y ClinicalSizeType

Y TextClinicalSizeType
 RangeClinicalSizeType
Y
ValueClinicalSizeType

Y RangeClinicalSizeType

Y Y MedicalHumanProductS
ubstanceType
Y Y SubstanceType

MedicalHumanProductS
Y Y
ubstanceType
 StorageHandlingConditi
Y Y Y
onType

CriticalWarningType
Y Y Y StorageHandlingConditi
onType

Y Y Y CriticalWarningType
 productDesignerTypeCh
Y Y Y
oice

productDesignerTypeCh
Y Y Y
oice

Y Y
Y Y Y OrganisationType

Y Y

Y Y

GeographicAddressTyp
Y Y Y
e

GeographicAddressTyp
Y Y Y
e
 GeographicAddressTyp
Y Y Y
e

GeographicAddressTyp
Y Y Y
e

GeographicAddressTyp
Y Y Y
e

GeographicAddressTyp
Y Y Y
e
 GeographicAddressTyp
Y Y Y
e

Y Y Y ElectronicContactType

Y Y Y ElectronicContactType

Y Y Y MarketInfoType
Y Y Y MarketInfoType

Y Y Y MarketInfoType

Y Y
XSD Element Name

issuingEntityCode

DICode

MFActorCode

applicableLegislation
systemDevice
procedurePackDevice

specialDevice

ARActorCode

riskClass

animalTissuesCells
model

name

humanTissuesCells

active

administeringMedicine
implantable

measuringFunction

reusable
companionDiagnostics

microbialSubstances

nearPatientTesting

selfTesting
reagent

professionalTesting

instrument

nonEUApplicableCountr
ies
nonEUApplicableCountr
ies

certificateType

certificateNumber
certificateRevisionNum
ber

NBActorCode

expiryDate
 issuingEntityCode

identifier

country (having
property
originalPlacedOnTheMa
rket True)
basicUDIIdentifier

MDNCode

latex
 numberOfReuses

If value provided is '-1',

device is considered as
non Single Use Device
and the device does not
have a maximum
number of reuses
(infinite number of
reuses)

If value provided is '0',

devices is considered
as Single use Device

If value provided is >1,

devices is considered
as non Single use
Device having a limited
number of reuses (the
value provided)

referenceNumber

reprocessed

provided through
numberOfReuses

If value provided is 0 for

numberOfReuses,
Device is considered as
Single use Device

If value provided is <>0

numberOfReuses (-1
or any value > 0),
Device is considered as
not being Single use
Device

sterile

sterilization
 website

additionalDescription

tradeNames

code

date

diIdentifier
 type

code

recalledPrecisions

recallScope

startDate

endDate
clinicalSizeType

minimum
value

precision

text
valueUnit

maximum

type
name

INN
storageHandlingConditi
onValue

comments

warningValue
productDesignerActorC
ode

productDesignerOrgani
sation
 names

street

streetNum
AddressComplement

PObox

city

postCode
country

phone

email

startDate
endDate

country
MDR Eudamed - Data Dictionary
EA
Field ID Field Label Entity Name

FLD-UDID-01 Issuing Entity Basic UDI-DI BasicUDIData

FLD-UDID-14 Basic UDI- DI BasicUDIData

FLD-UDID-44 System or Procedure Pack BasicUDIData

Producer SRN

FLD-UDID-16 Risk Class BasicUDIData

FLD-UDID-20 System or Procedure Pack BasicUDIData
Model

FLD-UDID-22 System/Procedure pack BasicUDIData

Name

FLD-UDID-40 Version BasicUDIData

FLD-UDID-260 Medical Purpose of the BasicUDIData

System or Procedure Pack

FLD-UDID-261 System or Procedure Pack BasicUDIData

EA EA
Field Description / Notes ENUM Reference Code Field Type

Assigned Issuing Entities that will ENUM_MDR_IssuingEntity Enum

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).

The Commission shall designate

one or several entities to operate
a system for assignment of UDIs
('issuing entity')

Device Identifier code/value (DI String

Code). Together with the Issuing
Entity creates the uniqness of the
element to which they are
assigned (Basic UDI-DI , UDI-DI,
etc.)

The Basic UDI-DI is the primary

identifier of a device model.It is
the main key for records in the
UDI database and is referenced
in relevant certificates and EU
declarations of conformity

SRN of the System or Procedure System or

Pack Procedure Pack
Provider

Highest Risk Class of the ENUM_UDID_RiskClass Enum

Devices in the System/Procedure
pack.
I nformation allowing the String
identification of the
System/Procedure pack Model.

At least one of the

System/Procedure pack
identification details
System/Procedure pack Model or
the System/Procedure pack
Name) have to be provided for a
Basic UDI-DI.

I nformation allowing the String

identification of the
System/Procedure pack Model.

At least one of the

System/Procedure pack
identification details
System/Procedure pack Model or
the System/Procedure pack
Name) have to be provided for a
Basic UDI-DI.

Reference to the version of the VersionData

Basic UDI Di

Description of the Medical LanguageSpecific

Purpose of the System or Content
Procedure Pack.

Field is applicable for System and

Procedure Packs and refers to
the Indication of the specific
medical purpose of the System or
Procedure Pack Producer

Determine if a System or a ENUM_UDID_SystemProcedurePa Enum

Procedure Pack ckType
Field Size Multilingual Occurrence Searchable GDPR Public Access
Flag Flag Flag

1 Y Y

XS

1 Y Y

SRN

1 Y Y

1 Y Y
XS

0..1 (Either SPP

Model or SPP Y Y
Name is required)

XS

0..1 (Either SPP

Model or SPP Y Y
Name is required)

1 Y

XL

Y 1 Y

1 Y Y
Updateable Field Applicable DTX Entity XSD Element Name
for MDR

Y DIIdentififierType issuingEntityCode

Y DIIdentififierType DICode

PRBasicUDIType PRActorCode

BasicUDIType riskClass

Y
 ModelNameGroup model

Y Y

ModelNameGroup name

Y Y

PRBasicUDIType medicinalPurpose

Y(only in case of
Y Systems and
procedure packs)

PRBasicUDIType type
Y(only in case of
Systems and
procedure packs)
MDR Eudamed - Data Dictionary
EA
Field ID Field Label Entity Name

FLD-UDID-291 Issuing Entity UDI-DI UDIData

FLD-UDID-178 UDI-DI UDIData

FLD-UDID-293 Issuing Entity Secondary DI UDIData

FLD-UDID-136 Secondary UDI - DI code UDIData

FLD-UDID-144 List of Critical Warnings or UDIData
Contraindications or Storage
and handling Conditions

FLD-UDID-312 List of Storage and handling UDIData

Conditions

FLD-UDID-145 Basic UDI-DI Identifier UDIData

FLD-UDID-148 Type of UDI-PI UDIData

FLD-UDID-149 Nomenclature code UDIData

FLD-UDID-163 Reference / Catalogue UDIData

Number

FLD-UDID-169 Device labelled sterile UDIData

FLD-UDID-170 Need for sterilisation before UDIData

use

FLD-UDID-174 URL for additional UDIData

information
FLD-UDID-175 Additional product UDIData
Description

FLD-UDID-176 Name/ Trade name UDIData

FLD-UDID-309 Container Packages related UDIData

to UDI-DI

FLD-UDID-130 System or Procedure Pack UDIData

Status

FLD-UDID-324 Status Date UDIData

FLD-UDID-256 Device Substatus UDIData

FLD-UDID-177 Version UDIData

FLD-UDID-131 System/Procedure pack DeviceSubStatus

SubStatus
FLD-UDID-122 Recall Precision DeviceSubStatus

FLD-UDID-123 Scope of Recall DeviceSubStatus

FLD-UDID-126 Start date DeviceSubStatus

FLD-UDID-127 End date DeviceSubStatus

FLD-UDID-211 Storage/handling conditions Storage and Handling

type (ConditionForUse)
FLD-UDID-213 Storage/Handling conditions Storage and Handling
Description (ConditionForUse)

FLD-UDID-212 Critical Warnings type Critical Warnings

(ConditionForUse)

FLD-UDID-319 Critical warnings or contra- Critical Warnings

indications Description (ConditionForUse)
EA EA
Field Description / Notes ENUM Reference Field Type Field
Code Size

Assigned Issuing Entities that ENUM_UDID_Issuin Enum

will generate the DI Codes gEntity
allocated for all DI`s inside
Eudamed (Basic UDI DI, UDI-
DI, Unit of Use DI, Secondary Di
, Package level DI).

The Commission shall designate

one or several entities to
operate a system for
assignment of UDIs ('issuing
entity')

The UDI-DI is a unique numeric String XS

or alphanumeric code specific to
a device and that is also used
as the 'access key' to
information stored in a UDI
database.

Assigned Issuing Entities that ENUM_UDID_Issuin Enum

will generate the DI Codes gEntity
allocated for all DI`s inside
Eudamed (Basic UDI DI, UDI-
DI, Unit of Use DI, Secondary Di
, Package level DI).

The Commission shall designate

one or several entities to
operate a system for
assignment of UDIs ('issuing
entity')

String XS
Secondary UDI DI Code -
reference to the Secondary UDI-
DI registered for the current
UDI-DI .

Additional DI associated to this

UDI-DI.
Only one Secondary UDI-DI
(Additional UDI-DI) can be
associated to a UDI-DI
References the Critical warnings Critical Warnings
or Storage and Handling (ConditionForUse)
Conditions associated to the
SPP ( list of Critical warnings or
Storage and Handling
Conditions associated to the
UDI-DI).

References the Storage and Storage and

Handling Conditions associated Handling
to the SPP (UDI-DI) (ConditionsForUse)

Reference to the Basic UDI-DI Basic UDI-DI

to which the System/Procedure
pack is associated.

Reference to the Types of UDI- ENUM_UDID_Produ Enum

PI (production Identifiers) ctionIdentifier
applicable for the current
System/Procedure pack (UDI-
DI). Defines the way the
production is controled

The Nomenclature Code(s) ENUM_UDID_MDN Enum

associated with the UDI-DI.
The corresponding CND
Nomenclature Code will be
stored in the field

Property stores the Reference String XS

or Catalogue Number of the
System/Procedure pack

Property defines if the Boolean

System/Procedure pack is
labeled as Sterile or not
Property defines if the Boolean
System/Procedure packneeds to
be sterilised before use or not

Manufacturer`s website where String M

additional information about the
device (UDI-DI) are available
Additional Product Description. LanguageSpecificCon L
tent
Additional Product Description is
required for System or
Procedure Packs or for
Standard Devices being marked
as System or Procedure Packs
(as a Device in themselvs)

System/Procedure pack Trade LanguageSpecificCon S

Name assigned to the UDI-DI tent

Trade names can be provided if

applicable for the device.
Several Trade- Names can be
provided for the Device in the
same language or in different
languages.

Reference to the Container Containeditem

Package associated to the UDI-
DI
Status of the System/Procedure ENUM_UDID_Devic Enum
pack (On the market, No longer eStatus
placed on the market).

Date from which the current Date

Status applies.

When performing updates on

the Device from the UI, value of
the field will be set up
automatically.

Stores a references to the DeviceSubstatus

Substatus of the System or
procedure Pack
Reference to the version of the VersionData
Device
SubStatus of the ENUM_UDID_Devic Enum
System/Procedure pack eSubStatus
(Recalled, Field safety
corrective action initiated)
When the Status of a LanguageSpecificCon L
System/Procedure pack is set to tent
FSCA Initiated or Recall, details
about the Scope of the Recall/
FSCA are required (description
of the serialnumber / 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)

When the Status of a ENUM_UDID_Devic Enum

System/Procedure pack is set to eScope
FSCA Initiated or Recall, details
about the Scope of the Recall/
FSCA are required (description
of the serialnumber / lot number,
etc.)

Field defines how the Scope of

the Recall is defined (by Lot
number, Serial Number , etc.)

Start Date when the Substatus Date

has been initialised

End Date when the Substatus Date

has been closed (Triggered by
Vigilance module)

Storage and handling ENUM_UDID_Stora Enum

Conditions specified on the geHandlingCondition
Label of the Device or in the
Instruction of Use have to be
registered in EUDAMED - if
applicable.

Field stores the Type of Storage

and Handling Conditions. Field
is Applicable only when the type
of Conditions for Use have the
Type Storage / handling
Conditions, being required in
this case.
Comments or description LanguageSpecificCon L
associated to the values tent
selected form the Storage or
handling Conditions or Critical
warnings

Storage and handling ENUM_UDID_Critica Enum

Conditions and Critical lWarnings
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.

Comments or description LanguageSpecificCon L

associated to the values tent
selected for the Critical warnings
Multilingual Occurrence Searchable GDPR Public Updateable
Flag Flag Access
Flag

1 Y Y

1 Y Y

0..1 Y Y

0..1 Y Y
0..n Y

0..n Y

1 Y

1..n Y

1..n Y Y Y

1 Y Y

1 Y Y

1 Y Y

0..1 Y Y
Y 1 Y Y

Y 0..n Y Y Y

0..n Y

1 Y Y

0..1 Y

0..1 Y Y

1 Y

0..n Y Y Y
Y 1 Y

1 Y

1 Y Y

0..1 Y Y

1 Y Y
 0..n (Required
for specific items
from the list of
Y Enumerations- Y Y
were additional
details are
required)

1 Y Y

0..n (Required
for specific items
from the list of
Y Enumerations- Y Y
were additional
details are
required)
Field DTX Entity XSD Element
Applicable for Name
MDR

Y DIIdentififierType issuingEntityCode

Y UDIDIType identifier

Y DIIdentififierType issuingEntityCode

Y PRUDIDIDataType secondaryIdentifier
Y

Y PRUDIDIDataType basicUDIIdentifier

Y PRUDIDIDataType productionIdentifier

Y PRUDIDIDataType MDNCode

Y PRUDIDIDataType referenceNumber

Y PRUDIDIDataType sterile

Y PRUDIDIDataType sterilization

Y PRUDIDIDataType website
 additionalDescriptio
Y PRUDIDIDataType
n

Y PRUDIDIDataType tradeNames

Y UDIDIStatusType code

Y UDIDIStatusType date

Y UDIDISubstatusType code
Y UDIDISubstatusType recalledPrecisions

Y UDIDISubstatusType recallScope

Y UDIDISubstatusType startDate

Y UDIDISubstatusType endDate

StorageHandlingConditio storageHandlingCo
Y
nType nditionValue
 CriticalWarningType
Y StorageHandlingConditio comments
nType

Y CriticalWarningType warningValue

CriticalWarningType
Y StorageHandlingConditio comments
nType
MDR Eudamed - Data Dictionary
EA
Field ID Field Label Entity Name

FLD-UDID-297 Issuing Entity Package UDI- ContainedItem

DI

FLD-UDID-120 Package UDI-DI ContainedItem

FLD-UDID-121 Quantity of item(s) ContainedItem

FLD-UDID-124 Related Package (/ UDI-DI) ContainedItem

FLD-UDID-130 Container Pack Status ContainedItem

FLD-UDID-324 Status Date ContainedItem

FLD-UDID-298 Version ContainedItem

EA EA
Field Description / Notes ENUM Reference Field Type Field
Code Size

Assigned Issuing Entities that ENUM_UDID_Issuin Enum

will generate the DI Codes gEntity
allocated for all DI`s inside
Eudamed (Basic UDI DI, UDI-
DI, Unit of Use DI, Secondary Di
, Package level DI).

The Commission shall designate

one or several entities to
operate a system for
assignment of UDIs ('issuing
entity')

Unique identifier of the Package String XS

UDI-DI.
Number of Items in the Package Number
Structure.

Used when describing the

Container Packaging Structure
of a Device.
Container Packaging Structure Containeditem
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.
Field will not be provided for the
lowest element - the UDI-DI

Status of the Container Package ENUM_UDID_Contai Enum

element (On the market, No nedItemStatus
longer placed on the market)

Date from which the current Date

Status applies.

When performing updates on

the Device from the UI, value of
the field will be set up
automatically.

Reference to the version of the VersionData

Container Package
Multilingual Occurrence Searchable GDPR Public Updateable
Flag Flag Access
Flag

1 Y Y

1 Y Y

1 Y
 1 Y

1 Y

0..1 Y

1 Y
Field Field DTX Entity XSD Element Name
Applicable for Applicable for
MDR IVDR

Y Y DIIdentififierType issuingEntityCode

Y Y UDIDIType identifier

Y Y PackageUDIType numberOfItems
Y Y PackageUDIType child

Y Y UDIDIStatusType code

Y Y UDIDIStatusType date

Y Y
MDR Eudamed - Data Dictionary
EA EA
Field ID Field Label Entity Name Field Description / ENUM
Notes Reference
Code

FLD-UDID-41 Comment ARComment Comments made by the

Authorised
Representative related
to the Device
FLD-UDID-42 Date ARComment Date when the
Authorised
Representative
submitted the comment
for the Device

FLD-UDID-43 ARSRN ARComment Authorised

Representative that
issued the comment

FLD-UDID-306 Basic UDI-DI ARComment Basic UDI-DI for which

for which the comments of the AR
comment is are issued
sent
EA
Field Type Field Multilingual Occurrence Searchable GDPR Public
Size Flag Flag Access
Flag

String M
1

Date

AuthorisedRepr XS
esentative
1

BasicUDIData
1
Updateable Field Field DTX Entity XSD
Applicable Applicable Element
for MDR for IVDR Name

CommentType comment
Y Y Y

CommentType date

Y Y

CommentType ownerActor
Code
Y Y

Y Y
MDR Eudamed - Data Dictionary
EA
Field ID Field Label Entity Name

FLD-UDID-96 Created Date VersionData

FLD-UDID-304 Device Submission Date VersionData

FLD-UDID-302 Document version StoredDocument

FLD-UDID-320 (Related text content) LanguageSpecificContent

FLD-UDID-321 Language LanguageSpecificContent

EA EA
Field Description / Notes ENUM Reference Field Type Field
Code Size

Date when the version was Date

initially created

Set up automatically by
EUDAMED system
Date when the Device data was Date
last submitted by the
manufacturer. Set up
automatically by EUDAMED
system

Version of the Document VersionData

Thetext provided by the user in the string L
selected language.
The language of the information ENUM_MDR_LANGU Enum
contained in field 'content'. AGE
Multilingual Occurrence Searchable GDPR Public Updateable
Flag Flag Access
Flag

1 Y

0..1 Y

1 Y
1 Y/N Y/N

1 Y Y
Field Field DTX Entity XSD Element Name
Applicable for Applicable for
MDR IVDR
Entity versionDate

Y Y

Y Y

Y Y
Y Y

Y Y