Medical Industry White Paper Unique Device Identification (UDI) (EN), Überblick



Beschreibung

Unique Device Identification (UDI)
Requirements, deadlines, secure labeling
The implementation of the UDI Directive is mandated for medical device manufacturers.
This is not only true for companies that sell their products on the American market, since
UDI is also being implemented in the EU and other countries. Medical products must be
clearly identified to ensure safe traceability and patient safety. In addition to the marking
of packaging and labels, this also applies to the direct marking of high risk products such as
implants and instruments. Manufacturers must maintain deadlines and requirements to
implement marking systems to apply marking in accordance with UDI requirements and
medical standards. In order to implement the demanding labeling, serialization and
marking requirements, appropriate technologies are required that allow the codes to be
applied and checked with high resolution, permanence with exceptional quality and, if
necessary, even in the smallest of spaces.


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Medical Industry White Paper

Unique Device Identification (UDI)

Requirements, deadlines, secure labeling

The implementation of the UDI Directive is mandated for medical device manufacturers.

This is not only true for companies that sell their products on the American market, since

UDI is also being implemented in the EU and other countries. Medical products must be

clearly identified to ensure safe traceability and patient safety. In addition to the marking

of packaging and labels, this also applies to the direct marking of high risk products such as

implants and instruments. Manufacturers must maintain deadlines and requirements to

implement marking systems to apply marking in accordance with UDI requirements and

medical standards. In order to implement the demanding labeling, serialization and

marking requirements, appropriate technologies are required that allow the codes to be

applied and checked with high resolution, permanence with exceptional quality and, if

necessary, even in the smallest of spaces.

Laser marked UDI-Codes

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U.S. Food and Drug Administration

Logo Sheet 1298.01

The UDI program:

Consistent labeling of medical devices for an increase in
patient safety and transparency in the supply chain

The UDI system will go into effect in stages, over a period of seven years, based on product risk level, starting
with the products with the highest risk class. The directive applies initially to the American market – that is
to say for medical products and devices that are produced or imported and are distributed in the USA – but is
also being introduced in other countries. Plans are underway to anchor the labeling requirement in the new
European Medical Device Regulation as well.

The declared goal of the UDI system is to increase patient safety and optimize patient care. The UDI system
addresses all of the following aspects:

More efficient product recalls

Improved counterfeiting protection

Simplification of data entry and accessibility with different systems

Security throughout the entire supply chain

Field Safety Corrective Actions – FSCA

Better identification, documentation and prevention of incidents

Reducing the chances of medical errors occurring (by quick and concise product identification, and the ability
to easily obtain important product information > Reducing number of misapplications)

Additionally, the labeling system allows for the simplification of logistics, ordering and delivery processes.

In 2013, the FDA (Food and Drug Administration) released the UDI Directive for the

uniform labeling of medical devices with the marking specification in its "final rule".

Standardized labeling is meant to enable the complete identification and tracking of

medical devices throughout the entire product life cycle. The European Union and

other countries are planning similar regulations.

UDI -Kennzeichnung von Medizinprodukten

In the near future:

UDI in the EU – Medical Device Regulation (MDR)
and "system of a unique product number"

In Europe, the implementation and introduction of a UDI
regulation is the responsibility of the European Commission.
For a long time, uniform guidelines for the traceability of
medical devices did not exist; the various member countries
developed different regulatory mechanisms, or did not
regulate traceability at all. (See Official Journal of the
European Union > 2013/172/EU, L 99/17)

1

In its proposal for a regulation on medical devices

2

, the

European Commission created Chapter III of the "Identifi-
cation and Traceability of Products". Article 24 deals with the
"system of the unique product number", which is intended
to enable the identification of medical products and facilitate
their traceability. This is not intended to regulate all aspects
of the UDI system, but concerns itself more with the
compatibility of the traceability mechanisms at the national
and/or regional level and the introduction of an obligatory,
internationally compatible UDI system (see Amtsblatt der
Europäischen Union > 2013/172/EU, L 99/18)

1

.

1

Official Journal of the EU (2013/172/EU):

http://eur-lex.europa.eu/LexUriServ/LexUriServ.
do?uri=OJ:L:2013:099:0017:0024:DE:PDF

In the EU, the UDI directive will be introduced as a "Unique Device Identification"* system

within the framework of the new European Medical Device Regulation (Medical Device

Regulation - MDR). First steps have already been taken in this direction; the regulation is

increasingly taking form.*

Currently: CE marking

Currently, medical products – in order to be marketed or put
into service on the European market – must bear a CE marking.
This can only be applied if a conformity assessment procedure
demonstrates that the product complies with the basic safety
and performance requirements laid down in the relevant Euro-
pean directives. Previously, it is required to pass a risk manage-
ment process, a clinical evaluation and a risk-benefit analysis.

The conformity assessment procedure must be carried out in
accordance with the risk class of the medical device, with the
participation of a privately operating, independent testing and
certification body (known entity) which is subject to a state

designation and reports to the appropriate authority. Only at
the lowest risk class I can the manufacturer carry out the
procedure under their own responsibility

CE marking and conformity declarations document

compliance with essential safety and performance
requirements and are a prerequisite for medical devices to
have access to the EU market

Background

The UDI system has emerged from an initiative set by the legis-
lators of the countries that form the

IMDRF

(International Med-

ical Device Regulatory Forum). As the first membership country
in the IMDRF to do so, the US implemented the UDI system, with
the start date of 24 September 2014, into law.

The implementation is the responsibility of the FDA (Food and
Drug Administration) and currently concerns medical products
sold in and imported into the American market.

FDA informationen under: http://www.fda.gov/MedicalDevic-
es/DeviceRegulationandGuidance/UniqueDeviceIdentification/

The UDI regulation will be introduced with the new
European Medical Devices Regulation and will apply to all
medical products and will require that they be re-certified
(MDR certificate). For manufacturers this means (among
other things):

technical documentation has to be revised

each product must be assigned a unique product
identification number ("unique device ID")

manufacturers must register themselves and EU-marketed
products in the EU database EUDAMED

medical products may have to be re-labeled and marked
(per the new legislation, after the respective transition
period, products will be required to carry a certificate when
they are first brought to market in the EU).

The new MDR is expected to be enforced in March 2017.
Depending on the risk class, UDI codes that have to be applied
directly on the device have to be implemented between 3 to 7
years after date of application (2020) – from  2023 to 2027.

2

Proposal for a Regulation on medical devices:

http://eur-lex.europa.eu/legal-content/EN/TXT/
PDF/?uri=CONSIL:ST_10617_2016_INIT

* Source

→ http://www.consilium.europa.eu/de/policies/new-

rules-medical-in-vitro-diagnostic-devices/

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Compliance Dates:

All deadlines at a glance

The UDI system is phased in in stages based on product classification risk level,

starting with the products with the highest risk class. Find below the labeling

deadlines for products manufactured in or imported into the United States.

UDI marking of medical devices

UDI codes on packaging or as direct marking:

What has to be marked where?

Where and when a UDI code has to be applied to a product depends on its

nature (risk class) and intended use. The UDI system differentiates between the

marking of the packaging or labels and direct marking on the product.

09.2014

09.2015

09.2016

09.2018

09.2020

Class III

labels,
packages

direct marking¹

Implantable, life-saving,
life-sustaining

labels, packages

direct marking¹

Class II

labels,
packages

direct marking¹

Class I and
non-classified

labels,
packages

direct
marking¹

The last deadline for the marking of packaging and labels
will be reached in 2018. At that point, the packaging and
labels of all class I-III products must carry a UDI code in plain
text and machine-readable form, using automatic identifi-
cation and data collection (AIDC) technology ab.

Compliance deadlines per risk classification

Acc. to 21 CFR 801.45 (b)

https://www.gpo.gov/fdsys/pkg/CFR-2014-title21-vol8/pdf/CFR-2014-title21-

vol8-sec801-45.pdf

the directly marked UDI code can be either identical with the one on the packaging,

or can be a different one in order to distinguish the packed device from the unpacked product.

Deadline

Labeling obligations apply to ...

September 24,
2014

→ Labels and packages of class III medical devices (acc. to 21 CFR 801.20)
→ Devices licensed under the Public Health Service Act (PHS Act), i.e. in-vitro diagnostics for donor scree-

nings (21 CFR 801.20)

→ Class III stand-alone software (21 CFR 801.50(b))

September 24,
2015

→ Labels and packages of implantable, life-supporting, and life-sustaining devices (21 CFR 801.20)
→ Life-supporting or life-sustaining devices that are required to be labeled with a UDI must bear a

UDI

as a permanent marking on the device itself

if the device is intended to be used more than once and

intended to be reprocessed before each use (21 CFR 801.45) → Compliance date extension for single use
implants that are intended to be sterilized or cleaned and sterilized before use) to September 2016¹

→ Life-supporting or life-sustaining stand-alone software (see 21 CFR 801.50(b))

September 24,
2016

Direct/permanent marking

of class III devices if the device is intended to be used more than once and

intended to be reprocessed before each use (i.e. cardiovascular or neurological catheter)

→ Class III medical devices (single use implants that are intended to be sterilized or cleaned and sterilized

before use) → Compliance date extension from 2015 to 2016!

→ Labels and packages of class II medical devices (21 CFR 801.20)
→ Class II stand-alone software (21 CFR 801.50(b))

September 24,
2018

→ Class II devices that are required to be labeled with a UDI must bear a

UDI as a permanent marking

, if

the devices are intended to be used more than once and intended to be reprocessed before each use
(21 CFR 801.45)

→ Labels and packages of class I products and devices that have not been classified into class I, II, or III
→ Class I stand-alone software (21 CFR 801.50(b))

September 24,
2020

→ Class I devices, and devices that have not been classified into class I, II, or III that are required to be la-

beled with a UDI, must bear

UDI as a permanent marking on the device itself

if the device is intended

to be used more than once and intended to be reprocessed before each use (21 CFR 801.45).

Source: Compliance Dates for UDI requirements (FDA)

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/

UniqueDeviceIdentification/CompliancedatesforUDIRequirements/default.htm

List of medical devices that FDA classifies as implantable, life-saving, and
life-sustaining devices

http://www.fda.gov/downloads/MedicalDevices/De-

viceRegulationandGuidance/UniqueDeviceIdentification/UCM382463.pdf

FDA's product classification database

http://www.accessdata.fda.gov/scripts/

cdrh/cfdocs/cfPCD/PCDSimpleSearch.cfm

¹

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuid-

ance/UniqueDeviceIdentification/UDIExceptionsAlternativesandTimeExten-
sions/UCM423853.pdf

Class I

Class II

Class III

low risk, general controls

moderate risk, general and special
controls

high risk, general controls and
premarket approval, life-saving and
life-sustaining

bandages

stethoscope

surgical scissors

dental floss

mechanical wheelchair

Infusion pumps

surgical sutures

bone screws

syringe

condoms

powered wheelchair

heart valves

knee prosthesis

pacemaker

automated external

defibrillators

Medical device classification differs in the USA and the EU. The EU distinguishes four classes (Class I, IIa and IIb and III) for low
to high risk. In the US, the FDA has defined three risk classes based on the degree of control needed to guarantee the safety and
efficacy of the products.

According to the FDA, direct marking is required for implants
and those devices intended to be reused over an extended pe-
riod of time (several months or years) and require reprocess-
ing (i.e. sterilization) before each use, as these will necessarily
be separated from the original packaging.

FDA risk categories

¹) if reused and reprocessed

Implants and Class III products do not necessarily have to bear a directly marked UDI code. No directly marked
UDI is required for sterile packaged implants that are unpacked directly at the implant site. A directly marked UDI
code is only required if the corresponding products are processed (for example, cleaned, sterilized or passivated)
before their use. Instruments that are repeatedly used and reprocessed must – depending on risk class – carry a
permanent UDI code by 2020 at the latest.

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Reliable and unique:

Code format, coding system and issuing agencies

According to 21 CFR 81.40, medical devices have to carry a UDI that is represented in two forms:

Easily readable plain-text (HRI/Human Readable Interpretation), alpha-numeric characters

AIDC technology (Automatic Identification and Data Capture), which means a machine readable code (bar
code/2D code).

In case the UDI code is applied as a permanent direct mark, it must be in either or both (1) easily readable
plain-text and (2) AIDC form or alternative technology (see 21 CFR 801.45).

Clear regulations apply for UDI codes, since only a uniform code

format and reliably readable marks and labels ensure reliable

traceability.

UDI marking of medical devices

Code format: UDI = DI + PI

UDI code examples

The UDI code in the AIDC form (linear bar code or Data
Matrix Code) is not a new code format, but uses existing
standards. However, some preconditions have to be fulfilled:

A UDI must be issued by a FDA-accredited issuing agency

The Unique Device Identifier must conform to international
ISO standards (ISO/IEC 15459–2, ISO/IEC 15459–4, ISO/IEC
15459–6) and may only use characters and numbers from
the invariant character set of ISO/IEC 646 standard (see 21
CFR 830.20).

The FDA has accredited three organizations as UDI Issuing
Agencies:

GS1

HIBCC (Health Industry Business Communications Council)

ICCBBA (International Council for Commonality in Blood
Banking Automation).

Both, the Health Industry Barcode (HIBC) and the GS1 code are
equally suitable for the UDI compliant marking of medical
products and devices. With the ISBT 128, the ICCBBA offers a
special system for products of human origin (blood, trans-
plants).

Coding system und issuing agency

GS1-128 linear bar code

GS1 DataMatrix code

Primary code
DI (Device Identifier)

Secondary code
PI (Production Identifier)

(01)47964367965424(11)173434(17)226565(10)A379B3(21)1237

machine readable

human

readable

(01)47964367965424

(11)173434

(17)226565

(10)A379B3(21)1237

machine readable

human readable

HIBC linear bar code

HIBC DataMatrix code

Primary code
DI (Device Identifier)

Secondary code
PI (Production Identifier)

+ELMI A20272 1/ $ B9030011/ S ACF7 C

machine readable

human

readable

+ELMI A20272 1/ $

B9030011/ S ACF7 C

machine readable

human readable

The Unique Device Identifier consists of two parts, the Device
Identifier (DI) and the Production Identifier (PI). An exception
are Class I medical devices, for which the labeling with the
Production Identifier is not required.

The Device Identifier (DI) is the mandatory, fixed portion of a
UDI that identifies the labeler and the device (specific version
or model). The DI contains the following static information:

Identifies the manufacturer/labeler

Specific version or model of device (also reference code)

This information serves as the key to obtain device informa-
tion in the UDI database (GUDID). The DI is a globally unique
product code which allows for the clear identification of a
device.

The Production Identifier (PI) is a conditional, variable por-
tion of a UDI that identifies one or more of the following
when included on the label of a device:

Lot and batch number (GS1 > 10)

Serial number (GS1 > 21)

Expiration date (GS1 > 17)

Date of manufacture (GS1 > 11)

Unique code for a human cell, tissue, or cellular or tissue-
based product

The selection of the related data elements depends on the
product (i.e. batch management requirement). The PI data are
only deposited in the code, they are not part of the GUDID.
The GUDID only tells if they are “existing” or “not existing”.
The format YYYY-MM-DD applies for all dates in text form
(HRI, Human Readable Interpretation), for example, March 2,
2017 must be represented as 2017-03-02 (see 21 CFR 801.18).

UDI code/unique device identifier (DI+PI)

Fictitious example of what a unique device
identifier (UDI) would look like on a medical
device label.

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GUDID:

The central UDI database

According to the UDI final specification, the manufacturer and labeler of each
medical device labeled with a unique device identifier (UDI) must submit in-
formation concerning that device to the GUDID.  Such device identification
information can be submitted either via GUDID Web Interface or as a xml file.

The GUDID contains only the data of the device identifier (DI), the variable
data of the UDI PI (Product Identifier) are exclusively on file in the code. How-
ever, the GUDID contains production identifier flags to indicate which PI at-
tribute(s) are on the device label.

Once a device is registered in the GUDID, both the public and all stakeholders
engaged in the production and usage can access information contained in the
GUDID. The GUDID will be linked to databases around the world and will
thus gain global influence.

UDI-Kennzeichnung von Medizinprodukten

Secure and reliable product identification marking

Challenges and solutions for manufacturers and labelers

The center of the American UDI system is the "Global Unique Device

Identification Database" (GUDID) that serves the registration and as a

reference catalog for every device with an identifier. The EU's equivalent

is the EUDAMED.

The requirements for the identification of medical devices are high. What is

more, are the special requirements on the UDI labeling. Innovative marking

systems not only solve these challenges but also contribute to an increase in

production efficiency and improved product quality.

The requirements on the marking of medical devices are
extremely stringent. Marks have to be...

permanent and traceable,

legible and readable,

high in contrast,

counterfeit-proof,

sterilization-resistant,

hygienic, clean, biocompatible

and in the case of metals such as stainless, corrosion-
resistant.

Due to the high demands on data quality of UDI codes, the
requirements for code readability, and as such the marking
quality, are especially precise.

UDI codes have to be readable

free of error

– only then can the required unique, consistent,

traceability be ensured.  This assumes that the marking itself
is error-free. The following points must be guaranteed:

The correct product must be marked with the correct code
(product conform).

The mark must be correctly positioned.

The code needs to legible over the long term (both plain
text and machine readable).

Many manufacturers apply vision systems for code
validation. Aspects tested include; legibility, contrast, code
positioning and the accuracy of the encoded data. Marking
systems with machine-integrated imaging are particularly
efficient. They save additional process and product handling
steps outside the marking system, as marking quality and
marked contents are verified directly in the marking station.
Furthermore, the positioning of the mark turns out to be
highly precise when aligned by the integrated camera system
before the marking takes place.

As the device marking is often one of the last production
steps, the direct marking must be applied reliably and safely.
In this late manufacturing stage, product scrap due to
incorrect markings is particularly costly. If marking errors can
be corrected, the correction is time-consuming and cost-
intensive. If they can't be corrected, the device itself has to be
scrapped. Using pre- and post marking image-assisted
validation and verification steps executed directly within the
marking system itself, as well as automatic mark alignment,
a machine-integrated vision system enables stable marking
processes and reliable, error-free marking results. The
advantages are obvious and include an increase in efficiency
and product quality and a decrease in scrap.

Benefits of vision-assisted marking solutions

Requirements on marking systems

Further information on the database
and data transfer:
http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
UniqueDeviceIdentification/
GlobalUDIDatabaseGUDID/default.htm

UDI codes on a suction catheter (left) and on a balloon catheter (right)

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UDI marking of medical devices

Making the right choice:

Marking technology for product marking

One of the major challenges facing UDI is the implementation of the appropri-

ate direct marking technology. The FDA does not specify which of the various

available options should be used. Moreover, not every method is suitable for

secure and UDI-compliant direct part marking; therefore choosing the best

method to meet the requirements can be difficult and is crucial.

The table shows standard marking methods with criteria rele-
vant for the marking of medical devices with UDI codes.

Marking characteristics

Good readability/high quality

yes

sometimes

sometimes

yes

no

Machine readable

yes

yes

yes

yes

difficult

High contrast

yes

sometimes

sometimes

yes

no

Permanent and erosion resistant

yes

unclear

unclear

unclear

yes

Biocompatible

yes

unclear

unclear

unclear

yes

Marking does not give bacteria
area to adhere to

yes

yes

yes

no

no

Resistant to acids, solvents,
cleaning and sterilization

yes

risk

risk

risk

yes

Corrosion resistant

yes

1

yes

yes

yes

risk

Passivation process resistant

yes

1

yes

yes

test required

risk

Characteristics of the marking process

Easy application of variable
data, codes, series production

yes

yes

yes

yes

yes

Consumables (ink, paint, glue,
etc.)

no

yes

yes

yes

no

Does not damage material

yes

yes

yes

yes

no

Low maintenance, low wear

yes

no

no

no

no

Adjustable marking size

yes

2

limited

limited

yes

limited

Marking at rests

yes

no

no

yes

yes

Marking on the fly (MOTF)

yes

yes

yes

yes

no

Marking of uneven surfaces

yes

no

no

risk³

limited

Possible marking methods
Laser marking
Inkjet (CIJ, Continuous Inkjet)
Thermal inkjet (TIJ)
Labels
Dot peen

¹) if used correctly
²) from <1mm² to 400x400mm
³) label attachement method

Above all, laser marking is ideally suited for the direct marking
of medical devices with the Unique Device Identifier. It fulfills
all the criteria relevant for safe product marking based on
medical standards and UDI requirements.

Advantages of laser marking

Laser marking, in combination with a machine-integrated
camera system, offers numerous advantages:

→   Process reliability, efficient and streamlined production:

accurate and very repeatable marking using integrated
camera system; stable marking processes; short processing
times

→   Error-free marks:

consistently high marking quality; accurate positioning of
the correct content on the right product; less scrap

→   Reliable traceability:

permanent, highly legible markings for safe product
identification; OCV (Optical Character Verification) and code
reading

→   Secure markings as required by medical standards:

biocompatible, sterilization- and cleaning-resistant
markings; contact-free, hygienic procedure

Overview of potential marking methods

Laser marking machine with integrated vision system for ins-
pection steps before and after marking.

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LASER KLASSE 4

LASER CLASS 4
Gem./According to

DIN EN 60825-1:2014

FOBA Laser Marking + Engraving

Alltec GmbH

ALLTEC GmbH
An der Trave 27-31
23923 Selmsdorf | Germany
T + 49 38823 55-0
F + 49 38823 55-222
info@fobalaser.com | www.fobalaser.com

© 2016 ALLTEC GmbH – All rights reserved. WP-UDI_EN_06.16

Laser marking of medical devices:

For reliable traceability, UDI compliance,
product safety and quality


The laser-based marking of medical products with the system, process and inte-
grated vision solutions that FOBA offers provides many advantages over alterna-
tive methods. We look forward to meeting with you for a live demonstration
at our application lab or at your site, and are happy to provide you with free
sample marking on your material.
Contact us:

info@fobalaser.com

Laser marking is ideal for direct part marking (DPM) to meet the UDI standard and is

ideally suited for serial applications with variable data and for mass production. The laser

produces high-quality, permanent, readable markings on products and packaging and

ensures the highest precision and process stability when combined with integrated vision

systems.