European

Commission

Unique Device
Identification (UDI) System
under the EU Medical Device Regulations
2017/745 and 2017/746

MEDICAL DEVICES CHANGE OF LEGISLATION

Introduction to the new

What you need to know!
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 25 May 2020 for medical devices
and 25 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).

The UDI system will facilitate easier traceability of medical The new system will be applied to all medical devices except
devices, significantly enhance the effectiveness of the post-mar- custom-made and performance study/investigational devices and
ket safety-related activities for devices and allow for better is substantially based on internationally recognised principles,
monitoring by competent authorities. It will also help to reduce notably by using definitions that are compatible with those used
medical errors and to fight against falsified devices. The use of by major trade partners.1,2
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 http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-131209-udi-guidance-140901.pdf

2 IMDRF/UDI WG/N48 FINAL: 2019 Unique Device Identification system (UDI system) Application Guide - DOCX (12.5Mb)

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Internal market,
Industry,
Entrepreneurship
and SMEs
Article 27 of Regulation (EU) 2017/745 (‘MDR’) and Article 24 of
Regulation (EU) 2017/746 (‘IVDR’) lay down that the UDI system
Frequently Asked
shall consist of: Questions and Answers
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 1. What is the UDI?
(‘UDI-PI’) that identifies the unit of device production and
if applicable the packaged devices, as specified in Part C The UDI is a series of numeric or alphanumeric characters that
of Annex VI; is created through a globally accepted device identification and
coding standard. It allows the unambiguous identification of a
b. the placing of the UDI carrier on the label of the device or specific medical device on the market. The UDI is comprised of the
on its packaging or in case of reusable devices on the device UDI-DI and UDI-PI. The unique identifier may include information
itself (direct marking); on the lot or serial number and be able to be applied anywhere
in the world.
c. the storage of the UDI by economic operators, health insti-
tutions and healthcare professionals, in accordance with the The production of a UDI comprises the following:
conditions laid down in paragraphs 8 and 9, respectively, of
the Articles; • A UDI device identifier (‘UDI-DI’) specific to a device, providing
access to the information laid down in Part B of Annex VI.
d. the establishment of an electronic database for Unique
Device Identification (the ‘UDI database’), which is part of • A UDI production identifier (‘UDI-PI’) that identifies the unit
the Eudamed database, in accordance with Article 28 of MDR of device production and if applicable the packaged devices,
and Article 25 of IVDR. as specified in Part C of Annex VI.

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 2. What is the Basic UDI-DI?
medical devices and performance study/investigational devices. The Basic UDI-DI is the main access key for device-related
The UDI carrier shall be placed on the label of the device and on all information in the Eudamed database and it is referenced in
higher levels of packaging and in case of reusable devices on the relevant documentation [e.g. certificates (including certificate of
device itself (direct marking). The manufacturer shall also ensure free sale), EU declaration of conformity, technical documentation
that the information – related to the device in question - referred and summary of safety and (clinical) performance)].
to in Part B and Part A, Section 2, of Annex VI of the relevant
Regulation, is correctly submitted to the European Database on It is intended to identify and connect devices with the same
Medical Devices (Eudamed) as required by Article 27(3) of MDR intended purpose, risk class and essential design and manufac-
and Article 24(3) of IVDR. The manufacturer shall also maintain turing characteristics.
unique UDIs for its devices.
It is independent/separate from the packaging/labelling of the
NOTE: Timelines related to those obligations are indicated under device and it does not appear on any trade item.
question 6 of this document.
Any Basic UDI-DI shall identify the devices (group) covered by
Within the EU, the manufacturer shall assign to their devices, that Basic UDI-DI in a unique manner.
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 Additional information on Basic UDI-DI is available at
and relevant documentation (e.g. certificates, declaration of https://ec.europa.eu/docsroom/documents/35382.
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.
3. Which products are subject to the UDI system?
UDI issuing entities designated by the European Commission The UDI system should apply to all devices, except custom-made
operate a system for the assignment of UDI in the EU.3 and performance study/investigational devices.

3 Issuing entities have been designated on 6 June 2019 via the Commission Implementing Decision (EU) 2019/939. 2
4. Who is responsible for placing the UDI carrier 6. What is the mandatory deadline for a device
on the device itself, on the label and on the to comply with the UDI requirements?
package of a device? The obligation for UDI assignment applies as from the date
The manufacturer is responsible for complying with all UDI related of application of the two new Regulations, i.e. 26 May 2020 for
requirements. This includes the assignment of the UDI (and Basic medical devices and 26 May 2022 for In Vitro diagnostic medical
UDI-DI), the UDI (and Basic UDI-DI) registration in the Eudamed devices.
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 obligation for submission of UDI data in the Eudamed
the device itself (direct marking). database applies mandatorily as from 26 November 2021 for
medical devices and 26 November 2023 for In Vitro diagnostic
4.1 What happens in the case of Article 16 of the MDR and medical devices (provided that registration of devices in Eudamed
IVDR? Which obligations do economic operators have is fully functional before the date of application, otherwise 24
regarding UDI when assuming obligation incumbent months after the availability of Eudamed functionality). However,
on manufacturers per Article 16 of the MDR and IVDR? manufacturers will be in a position to voluntarily comply with
registration obligations as from 26 May 2020 for medical devices
Any distributor, importer or other natural or legal person that and 26 May 2022 for In Vitro diagnostic medical devices.
assumes the obligations incumbent on manufacturers in accord-
ance with Article 16(1), assumes all the relevant responsibilities It shall be noted that, provided that Eudamed is fully functional,
related to UDI, including UDI labelling. at any time after 26 May 2020 for medical devices and 26 May
2022 for In Vitro diagnostic medical devices, the full registration
The distributor or importer carrying out the operations described of devices (Article 29 of MDR and Article 26 of IVDR) remains a
in Article 16(2) (providing translation or repackaging of devices) pre-condition for the possible registration of their relevant serious
shall ensure that: incident in Eudamed.

• the activities are performed by means and under conditions More information on this subject is available at https://ec.europa.
that in no way compromise the readability of the UDI carrier eu/docsroom/documents/34921.
and its information identifying the actual device.
The obligation for placing the UDI carrier applies according
• the specific procedures are part of the distributor’s or import- to the following timelines:
er’s quality management system.
Implantable Class IIa and
Device as per Class I
A dedicated guideline with additional information on this aspect is devices and Class IIb
Regulation (EU) 2017/745 (MDR) devices
Class III devices devices
available at https://ec.europa.eu/docsroom/documents/31927.
Placing UDI-carriers
26 May 26 May 26 May
on the labels of devices
MDR Article 123(3)(f), Article 27(4) 2021 2023 2025
5. What is the procedure for systems and procedure Direct marking of the
26 May 26 May 26 May
packs to undergo a UDI registration? reusable devices
2023 2025 2027
MDR Article 123(3)(g), Article 27(4)
Systems and procedure packs shall undergo a UDI registration,
as described in Article 29(2) of MDR.
Device as per Class D Class C and B Class A
Before placing on the market a system or procedure pack pursuant Regulation (EU) 2017/746 (IVDR) IVDs IVDs IVDs
to Article 22(1) and (3), that is not a custom-made device, the Placing UDI-carriers on the
26 May 26 May 26 May
system or procedure pack producer shall assign to the system or labels of devices
2023 2025 2027
procedure pack, in compliance with the rules of the issuing entity, IVDR Article 113(3)(e), Article 24(4)
a Basic UDI-DI and shall provide it to the Eudamed database
together with the other relevant core data elements listed in the
document https://ec.europa.eu/docsroom/documents/31925.
NOTE: Devices which are compliant with the Regulations may be placed on
the market ahead of the general application date of 26 May 2020 (MDR) and
Further information on rules applicable to systems and pro- 26 May 2022 (IVDR). For more information on this aspect, please consult
cedure packs is available at https://ec.europa.eu/docsroom/ the answers provided to questions 5 and 6 in the following documents
documents/31924. https://www.camd-europe.eu/wp-content/uploads/2018/05/FAQ_MDR_ 180117_
V1.0-1.pdf and https://www.camd-europe.eu/wp-content/uploads/2018/05/
FAQ_IVDR_180117_V1.0-1.pdf.

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7. Are devices, which are compliant with the 9. How should a UDI appear on the label or
Medical Device Directives (MDD and AIMDD) package of a device?
and placed on the market after the applica- The UDI Carrier [Automated Identification for Data Capture (AIDC)
tion date of the Regulations (legacy devices), and human readable interpretation (HRI) representation of the
continue to be subject to UDI requirements? UDI] shall be on the label or on the device itself and on all higher
levels of device packaging.
In order to facilitate the transition to the new system, the new
Regulations give manufacturers the possibility to place products In the event of significant space constraints on the unit of use
on the market after the general application dates of the new packaging, the UDI carrier may be placed on the next higher
Regulations (and until 26 May 2024 at the latest) by virtue of packaging level.
valid Directive certificates.4
Higher levels of packaging shall have their own unique UDI.
These legacy devices are not subject to UDI obligations but they Please note that shipping containers shall be exempted from
should be registered in the Eudamed database. Timelines for the requirement.
registration as described under question 6 also apply to these
products. More information on the operational aspects of the The UDI must appear in a plain-text version/human readable
registration of legacy devices is available at https://ec.europa. information (HRI) and in a form that uses AIDC technology. AIDC
eu/docsroom/documents/34922. 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
8. What is the role of the UDI issuing entities?
can easily be read by people.
Who designates them?
The issuing entities operate a system for the assignment of UDIs. If there are significant constraints limiting the use of both AIDC
and HRI on the label, only the AIDC format shall be required to
Following a call for applications launched at the end of 2018, the appear on the label.
Commission has designated the following entities:
For devices intended to be used outside healthcare facilities, such
a. GS1 AISBL 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.
b. Health Industry Business Communications Council (HIBCC)
For other specific requirements related to the UDI carrier, please
c. International Council for Commonality in Blood Banking consult Section 4 of Annex VI Part C of the two Regulations.
Automation (ICCBBA)
For single-use devices of classes I and IIa medical devices and
d. Informationsstelle für Arzneispezialitäten (IFA) GmbH class A and class B IVD medical devices packaged and labelled
individually, the UDI carrier shall not be required to appear on
For more information, please refer to the relevant implement- the packaging but it shall appear on a higher level of packaging,
ing act designating the entities: Commission Implementing e.g. a carton containing several (individually packaged) devices.
Decision (EU) 2019/939 of 6 June 2019 designating issuing However, when the healthcare provider is not expected to have
entities designated to operate a system for the assignment access, in cases such as in home healthcare settings, to the
of Unique Device Identifiers (UDIs) in the field of medi- higher level of device packaging, the UDI shall be placed on the
cal devices. This is available at https://eur-lex.europa.eu/ packaging (of the individual device).
legal-content/EN/TXT/?uri=uriserv:OJ.L_.2019.149.01.0073.01.
ENG&toc=OJ:L:2019:149:TOC. 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.

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 FAQs papers published by the CAMD Transitional Task-force
(https://www.camd-europe.eu/regulatory/available-now-mdr-ivdr-transitional-faqs).

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10. Are there any requirements for the PI 12. What are the obligations of economic operators
(Production Identifier) information? and health institutions in relation to UDI?
If a lot number, serial number, software identification or expiry According to the two medical devices Regulations, manufacturers
date appears on the label, it shall be part of the UDI-PI. If there shall be responsible for the UDI assignment and placement of the
is also a manufacturing date on the label, it does not need to be UDI carrier, the initial submission and updates of the identifying
included in the UDI-PI. If there is only a manufacturing date on information and other device data elements in the Eudamed
the label, this shall be used as the UDI-PI. database. Manufacturers shall update the relevant database
record within 30 days of a change being made to an element,
The different types of UDI-PIs include serial number, lot number, which does not require a new UDI-DI.
software identification and manufacturing date and/or expiry date.
The UDI-PI characteristics such as the lot or serial number shall Distributors and importers shall verify that, where applicable, a
be defined by the manufacturer. However: UDI has been assigned by the manufacturer.

• For active implantable devices, the UDI-PI shall include at All economic operators and health institutions shall store and
least the serial number; for other implantable devices, the keep preferably by electronic means the UDI of the devices, which
serial number or lot number. they have supplied or with which they have been supplied if
those devices belong to class III implantable devices. Please note
• A configurable device UDI-PI shall be assigned to each indi- that the Commission may decide to adopt implementing acts to
vidual configurable device. expand the scope of devices for which economic operators shall
store and keep the UDI.
It is important to note that no UDI-PI information can be included
in the UDI database.
13. Is the software subject to UDI rules?
The UDI shall be assigned at the system level of the software.
11. What changes in the medical device would
require a new UDI-DI? Only software that is commercially available on its own and
A new UDI-DI shall be required whenever there is a change that software that constitutes a device in itself shall be subject to
could lead to misidentification of the device and/or ambiguity that requirement.
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 The software identification shall be considered the manufacturing
name, device version or model, labelled as single use, packaged control mechanism and shall be displayed in the UDI-PI.
sterile, need for sterilisation before use, quantity of devices
provided in a package, critical warnings or contra-indications and UDI requirements for software are laid down in Annex VI Part C
CMR/Endocrine disruptors. of the two medical device Regulations.

A UDI-DI shall be associated with one and only one Basic UDI-DI. A dedicated guideline with additional information on this aspect is
available at https://ec.europa.eu/docsroom/documents/31926.
Additional information on this aspect is available at
https://ec.europa.eu/docsroom/documents/35382?locale=en.

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 ET-02-18-963-EN-N
14. Direct marking of reusable devices. Are there However, the UDI Expert Group will analyse requests for adap-
exemptions? tation of UDI requirements to certain specific device types and
recommend the Medical Device Coordination Group (MDCG) to
Devices that are reusable shall bear a UDI carrier on the device issue dedicated guidelines, where necessary.
itself.

The UDI carrier for reusable devices that require disinfection, ster-
ilisation or refurbishing between patient uses shall be permanent 16. What are the UDI and device data sets to be
and readable after each process performed to make the device provided in Eudamed?
ready for the subsequent use throughout the intended lifetime
Two dedicated guidelines containing information on this aspect,
of the device.
concerning the MDR and IVDR, are available at https://ec.europa.eu/
The UDI carrier shall be readable during normal use and throughout growth/sectors/medical-devices/new-regulations/guidance_en.
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; Guidance
• the device cannot be directly marked because it is not tech-
nologically feasible.
Further Guidance on UDI is available at https://ec.europa.eu/
growth/sectors/medical-devices/guidance_en.
15. Is there an adjudication process for ad-hoc
NOTE: The Commission intends to expand this document on a regular
exemptions foreseen for medical devices? basis based on the assessment of most frequently asked questions and/
or of other specific needs.
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.

01/08/2019

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