Introduction to the new 
UDI system and the 
obligations of operators
The existing regulatory framework on medical 
devices dates back to the 1990s and consists of 
three Directives. Two new Regulations (Regulation 
(EU) 745/2017 on medical devices and Regulation 
(EU) 746/2017 on  In Vitro  diagnostic medical devices) 
were adopted in April 2017 and entered into force on 
25 May 2017. The general application dates of the 
two Regulations are 26 May 2021 for medical devices 
and 26 May 2022 for In Vitro  diagnostic medical 
devices, though different timelines apply for certain 
specific provisions. 
These Regulations introduce an EU identification sys -
tem for medical devices based on a Unique Device 
Identifier (UDI).
1The UDI system will facilitate easier traceability of medical 
devices, significantly enhance the effectiveness of the post-mar -
ket safety-related activities for devices and allow for better 
monitoring by competent authorities. It will also help to reduce 
medical errors and to fight against falsified devices. The use of 
the UDI system finally should also improve purchasing and waste 
disposal policies and stock-management by health institutions 
and other economic operators.
1  IMDRF/UDI WG/N7FINAL:2013  UDI Guidance Unique Device Identification (UDI) of Medical Device s
2  IMDRF/UDI WG/N48 FINAL: 2019 Unique Device Identification system (UDI system) Application Guide - DOCX (12.5Mb)The new system will be applied to all medical devices except 
custom-made and performance study/investigational devices and 
is substantially based on internationally recognised principles, 
notably by using definitions that are compatible with those used 
by major trade partners.1,2MEDICAL DEVICES  CHANGE OF LEGISLATION
What you need to know! 
Unique Device  
Identification (UDI) System  
under the EU medical devices Regulations 
2017/745 and 2017/746European 
Commission
Health and Food 
Safety 2Article 27 of Regulation (EU) 2017/745 (‘MDR’) and Article 24 of 
Regulation (EU) 2017/746 (‘IVDR’) lay down that the UDI system 
shall consist of:
a. the production of a UDI that comprises a UDI device identifier 
(‘UDI-DI’) specific to a manufacturer and a device, providing 
access to the information, and a UDI production identifier 
(‘UDI-PI’) that identifies the unit of device production and 
if applicable the packaged devices, as specified in Part C 
of Annex VI;
b. the placing of the UDI carrier on the label of the device or 
on its packaging or in case of reusable devices on the device 
itself (direct marking);
c. the storage of the UDI by economic operators, health insti -
tutions and healthcare professionals, in accordance with the 
conditions laid down in paragraphs 8 and 9, respectively, of 
the Articles;
d. the establishment of an electronic database for Unique 
Device Identification (the ‘UDI database’), which is part of 
the Eudamed database, in accordance with Article 28 of MDR 
and Article 25 of IVDR.
In accordance with the new rules, any manufacturer shall thus 
assign a unique UDI to a device and to all higher levels of packag -
ing before placing that device on the market except custom-made 
medical devices and performance study/investigational devices. 
The UDI carrier shall be placed on the label of the device and on all 
higher levels of packaging and in case of reusable devices on the 
device itself (direct marking). The manufacturer shall also ensure 
that the information – related to the device in question - referred 
to in Part B and Part A, Section 2, of Annex VI of the relevant 
Regulation, is correctly submitted to the European Database on 
Medical Devices (Eudamed) as required by Article 27(3) of MDR 
and Article 24(3) of IVDR. The manufacturer shall also maintain 
unique UDIs for its devices.
NOTE: Timelines related to those obligations are indicated under 
question 6 of this document.
Within the EU, the manufacturer shall assign to their devices, 
together with a UDI, also a Basic UDI-DI, which is not yet required 
by other jurisdictions. The Basic UDI-DI is the main key in Eudamed 
and relevant documentation (e.g. certificates, declaration of 
conformity, technical documentation and summary of safety 
and clinical performance) and will also be the access key for 
device-related information entered in the database.
UDI issuing entities designated by the European Commission 
operate a system for the assignment of UDI in the EU.3
3  Issuing entities have been designated on 6 June 2019 via the Commission Implementing Decision (EU) 2019/939 .Frequently Asked  
Questions and Answers
1. What is the UDI?
The UDI is a series of numeric or alphanumeric characters that 
is created through a globally accepted device identification and 
coding standard. It allows the unambiguous identification of a 
specific medical device on the market. The UDI is comprised of the 
UDI-DI and UDI-PI. The unique identifier may include information 
on the lot or serial number and be able to be applied anywhere 
in the world.
The production of a UDI comprises the following:
• A UDI device identifier (‘UDI-DI’) specific to a device, providing 
access to the information laid down in Part B of Annex VI.
• A UDI production identifier (‘UDI-PI’) that identifies the unit 
of device production and if applicable the packaged devices, 
as specified in Part C of Annex VI.
2. What is the Basic UDI-DI?
The Basic UDI-DI is the main access key for device-related 
information in the Eudamed database and it is referenced in 
relevant documentation [e.g. certificates (including certificate of 
free sale), EU declaration of conformity, technical documentation 
and summary of safety and (clinical) performance)].
It is intended to identify and connect devices with the same 
intended purpose, risk class and essential design and manufac -
turing characteristics.
It is independent/separate from the packaging/labelling of the 
device and it does not appear on any trade item.
Any Basic UDI-DI shall identify the devices (group) covered by 
that Basic UDI-DI in a unique manner.
MDCG 2018-1 v3  guidance provides additional information on 
Basic UDI-DI.
3. Which products are subject to the UDI system?
The UDI system should apply to all devices, except custom-made 
and performance study/investigational devices.34.  Who is responsible for placing the UDI carrier 
on the device itself, on the label and on the 
package of a device?
The manufacturer is responsible for complying with all UDI related 
requirements. This includes the assignment of the UDI (and Basic 
UDI-DI), the UDI (and Basic UDI-DI) registration in the Eudamed 
database and the placement of the UDI carrier on the label of 
the device or on its packaging or, in case of reusable devices, on 
the device itself (direct marking).
4.1 What happens in the case of Article 16 of the MDR and 
IVDR? Which obligations do economic operators have 
regarding UDI when assuming obligation incumbent 
on manufacturers per Article 16 of the MDR and IVDR?
Any distributor, importer or other natural or legal person that 
assumes the obligations incumbent on manufacturers in accord -
ance with Article 16(1), assumes all the relevant responsibilities 
related to UDI, including UDI labelling. 
The distributor or importer carrying out the operations described 
in Article 16(2) (providing translation or repackaging of devices) 
shall ensure that: 
• the activities are performed by means and under conditions 
that in no way compromise the readability of the UDI carrier 
and its information identifying the actual device. 
• the specific procedures are part of the distributor’s or import -
er’s quality management system.
A dedicated guideline with additional information on this aspect 
is available at the MDCG 2018-6 guidance document .
5.  What is the procedure for systems and procedure 
packs to undergo a UDI registration?
Systems and procedure packs shall undergo a UDI registration, 
as described in Article 29(2) of MDR.
Before placing on the market a system or procedure pack pursuant 
to Article 22(1) and (3), that is not a custom-made device, the 
system or procedure pack producer shall assign to the system or 
procedure pack, in compliance with the rules of the issuing entity, 
a Basic UDI-DI and shall provide it to the Eudamed database 
together with the other relevant core data elements listed in the 
MDCG 2018-4 guidance document .6.  What is the mandatory deadline for a device 
to comply with the UDI requirements?
The obligation for UDI assignment applies as from the date 
of application of the two new Regulations, i.e. 26 May 2021 for 
medical devices and 26 May 2022 for In Vitro  diagnostic medical 
devices.
The obligation for submission of UDI data in the EUDAMED 
database  applies from 26 November 2022 for medical devices 
and 26 November 2023 for in vitro  diagnostic medical devices 
(provided that EUDAMED is fully functional before the date of 
application of the respective Regulation; otherwise, this obligation 
applies 24 months after EUDAMED has become fully functional)
However, manufacturers will be in a position to voluntarily comply 
with registration obligations as from 26 May 2021 for medical 
devices and 26 May 2022 for  In Vitro  diagnostic medical devices.
It shall be noted that, provided that Eudamed is fully functional, 
at any time after 26 May 2021 for medical devices and 26 May 
2022 for In Vitro  diagnostic medical devices, the full registration 
of devices (Article 29 of MDR and Article 26 of IVDR) remains a 
pre-condition for the possible registration of their relevant serious 
incident in Eudamed.
The MDCG 2019-4  guidance document provides more information 
on this subject.
The obligation for placing the UDI carrier applies according 
to the following timelines:
Device as per
Regulation (EU) 2017/745  (MDR)Implantable  
devices and 
Class III devicesClass IIa and
Class IIb 
devicesClass I  
devices
Placing UDI-carriers  
on the labels of devices
MDR Article 123(3)(f), Article 27(4)26 May  
202126 May  
202326 May  
2025
Direct marking of the  
reusable devices
MDR Article 123(3)(g), Article 27(4)26 May  
202326 May  
202526 May  
2027
Device as per
Regulation (EU) 2017/746 (IVDR)Class D 
IVDsClass C and B 
IVDsClass A 
IVDs
Placing UDI-carriers on the  
labels of devices
IVDR Article 113(3)(e), Article 24(4)26 May 
202326 May  
202526 May 
2027
NOTE: Devices which are compliant with the Regulations may be placed on 
the market ahead of the general application date of 26 May 2021 (MDR) and 
26 May 2022 (IVDR). For more information on this aspect, please consult  
FAQ - MDR Transitional Provisions  and FAQ - IVDR Transitional Provisions .47.  Are devices, which are compliant with the 
Medical Device Directives (MDD and AIMDD) 
and placed on the market after the applica -
tion date of the Regulations (legacy devices), 
continue to be subject to UDI requirements?
In order to facilitate the transition to the new system, the new 
Regulations give manufacturers the possibility to place products 
on the market after the general application dates of the new 
Regulations (and until 26 May 2024 at the latest) by virtue of 
valid Directive certificates.4
These legacy devices are not subject to UDI obligations but they 
should be registered in the Eudamed database. Timelines for 
registration as described under question 6 also apply to these 
products. More information on the operational aspects of the 
registration of legacy devices is available at the MDCG 2019-5 
guidance document .
8.  What is the role of the UDI issuing entities? 
Who designates them?
The issuing entities operate a system for the assignment of UDIs.
Following a call for applications launched at the end of 2018, the 
Commission has designated the following entities:
a. GS1 AISBL
b. Health Industry Business Communications Council (HIBCC)
c. International Council for Commonality in Blood Banking 
Automation (ICCBBA)
d. Informationsstelle für Arzneispezialitäten (IFA) GmbH
For more information, please refer to the relevant implementing 
act designating the entities: Commission Implementing Decision 
(EU) 2019/939  of 6 June 2019 designating issuing entities 
designated to operate a system for the assignment of Unique 
Device Identifiers (UDIs) in the field of medical devices. 
4 For additional information on the general conditions for legacy devices to be placed on the market after the general application dates of the new  
 Regulations, see the MDR and IVDR transitional FAQs  published by the CAMD Transitional Task-force  9.  How should a UDI appear on the label or  
package of a device?
The UDI Carrier [Automated Identification for Data Capture (AIDC) 
and human readable interpretation (HRI) representation of the 
UDI] shall be on the label or on the device itself and on all higher 
levels of device packaging.
In the event of significant space constraints on the unit of use 
packaging, the UDI carrier may be placed on the next higher 
packaging level.
Higher levels of packaging shall have their own unique UDI. 
Please note that shipping containers shall be exempted from 
the requirement.
The UDI must appear in a plain-text version/human readable 
information (HRI) and in a form that uses AIDC technology. AIDC 
means any technology that conveys the unique device identifier 
or the device identifier of a device in a form that can be entered 
into an electronic patient record or another computer system via 
an automated process. The HRI consists of legible characters that 
can easily be read by people.
If there are significant constraints limiting the use of both AIDC 
and HRI on the label, only the AIDC format shall be required to 
appear on the label.
For devices intended to be used outside healthcare facilities, such 
as devices for home care, the HRI shall, however, appear on the 
label even if this results in there being no space for the AIDC.
For other specific requirements related to the UDI carrier, please 
consult Section 4 of Annex VI Part C of the two Regulations.
For single-use devices of classes I and IIa medical devices and 
class A and class B IVD medical devices packaged and labelled 
individually, the UDI carrier shall not be required to appear on 
the packaging but it shall appear on a higher level of packaging, 
e.g. a carton containing several (individually packaged) devices. 
However, when the healthcare provider is not expected to have 
access, in cases such as in home healthcare settings, to the 
higher level of device packaging, the UDI shall be placed on the 
packaging (of the individual device).
For devices exclusively intended for retail point of sale, the UDI-
PIs in AIDC shall not be required to appear on the point of sale 
packaging. 
If the UDI carrier is readily readable or, in the case of AIDC, 
scannable, through the device’s packaging, the placing of the UDI 
carrier on the packaging shall not be required.510.  Are there any requirements for the PI  
(Production Identifier) information?
If a lot number, serial number, software identification or expiry 
date appears on the label, it shall be part of the UDI-PI. If there 
is also a manufacturing date on the label, it does not need to be 
included in the UDI-PI. If there is only a manufacturing date on 
the label, this shall be used as the UDI-PI.
The different types of UDI-PIs include serial number, lot number, 
software identification and manufacturing date and/or expiry date. 
The UDI-PI characteristics such as the lot or serial number shall 
be defined by the manufacturer. However:
• For active implantable devices, the UDI-PI shall include at 
least the serial number; for other implantable devices, the 
serial number or lot number. 
• A configurable device UDI-PI shall be assigned to each indi -
vidual configurable device.
It is important to note that no UDI-PI information can be included 
in the UDI database.
11.  What changes in the medical device would 
require a new UDI-DI?
A new UDI-DI shall be required whenever there is a change that 
could lead to misidentification of the device and/or ambiguity 
in its traceability. In particular, a new UDI-DI shall be required in 
the case of any change of the following elements: name or trade 
name, device version or model, labelled as single use, packaged 
sterile, need for sterilisation before use, quantity of devices 
provided in a package, critical warnings or contra-indications and 
CMR/Endocrine disruptors.
A UDI-DI shall be associated with one and only one Basic UDI-DI.
Additional information on this aspect is available at  MDCG 
2018-1 v3 guidance document .12.  What are the obligations of economic operators 
and health institutions in relation to UDI?
According to the two medical devices Regulations, manufacturers 
shall be responsible for the UDI assignment and placement of the 
UDI carrier, the initial submission and updates of the identifying 
information and other device data elements in the Eudamed 
database. Manufacturers shall update the relevant database 
record within 30 days of a change being made to an element, 
which does not require a new UDI-DI.
Distributors and importers shall verify that, where applicable, a 
UDI has been assigned by the manufacturer.
All economic operators and health institutions shall store and 
keep preferably by electronic means the UDI of the devices, which 
they have supplied or with which they have been supplied if 
those devices belong to class III implantable devices. Please note 
that the Commission may decide to adopt implementing acts to 
expand the scope of devices for which economic operators shall 
store and keep the UDI.
13.  Is the software subject to UDI rules?
The UDI shall be assigned at the system level of the software.
Only software that is commercially available on its own and 
software that constitutes a device in itself shall be subject to 
that requirement.
The software identification shall be considered the manufacturing 
control mechanism and shall be displayed in the UDI-PI.
UDI requirements for software are laid down in Annex VI Part C 
of the two medical device Regulations.
A dedicated guideline with additional information on this aspect 
is available at MDCG 2018-5 guidance document .614.  Direct marking of reusable devices. Are there 
exemptions?
Devices that are reusable shall bear a UDI carrier on the device 
itself.
The UDI carrier for reusable devices that require disinfection, ster -
ilisation or refurbishing between patient uses shall be permanent 
and readable after each process performed to make the device 
ready for the subsequent use throughout the intended lifetime 
of the device.
The UDI carrier shall be readable during normal use and throughout 
the intended lifetime of the (reusable) device.
The requirements shall not apply to the device in case of the 
following circumstances:
• any type of direct marking would interfere with the safety 
or performance of the device;
• the device cannot be directly marked because it is not tech -
nologically feasible.
15.  Is there an adjudication process for ad-hoc 
exemptions foreseen for medical devices?
An adjudication process to allow for ad-hoc exemptions is not 
envisaged in the EU. All devices are therefore subject in principle 
to UDI requirements, with the only exceptions explicitly stated in 
the Regulation.However, the UDI Expert Group will analyse requests for adap -
tation of UDI requirements to certain specific device types and 
recommend the Medical Device Coordination Group (MDCG) to 
issue dedicated guidelines, where necessary.
16.  What are the UDI and device data sets to be 
provided in Eudamed?
Dedicated guidelines containing information on this aspect 
are available at https://ec.europa.eu/health/md_sector/
new_regulations/guidance .
Guidance
Further information on EUDAMED is available at  https://ec.europa.
eu/health/md_eudamed/overview_en .
NOTE: The Commission intends to expand this document on a regular 
basis based on the assessment of most frequently asked questions and/
or of other specific needs.
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