IMDRF/GRRP WG/N52 FINAL:2019

IMDRF International Medical

Device Regulators Forum

FINAL DOCUMENT

International Medical Device Regulators Forum

Title: Principles of Labelling for Medical Devices and IVD Medical Devices

Authoring
Group: IMDRF Good Regulatory Review Practices

Date: 21 March 2019

Elena M. Astapenko, IMDRF Chair

This document was produced by the International Medical Device

Regulators Forum. There are no restrictions on the reproduction or use of
this document; however, incorporation of this document, in part or in
whole, into another document, or its translation into languages other than
English, does not convey or represent an endorsement o f any kind by the
International Medical Device Regulators Forum.

Copyright © 2019 by the International Medical Device Regulators Forum.

 IMDRF/GRRP WG/N52

Table of Contents

1.0 Scope............................................................................................................................................. 5
2.0 References..................................................................................................................................... 5
3.0 Definitions..................................................................................................................................... 7
4.0 Principles for Medical Device and IVD Medical Device Identification...............................13
5.0 General Labelling Principlesfor Medical Devices and IVD Medical D evices.................... 14
6.0 General Labelling Principlesfor Medical Devices other than IVD Medical Devices.........23
7.0 General Labelling Principles for IVD Medical Devices........................................... 24
8.0 Labelling Principles for Medical Devices Containing Software or Software as a Medical
D evice......................................................................................................................................... 25
9.0 Labelling Principles for Medical Devices and IVD Medical Devices Intended for Use by
Lay Persons................................................................................................................................ 26
10.0 Labelling Principles for Information Intended for the Patient.............................................. 27

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Preface

The document herein was produced by the International Medical Device Regulators Forum
(IMDRF), a voluntary group o f medical device regulators from around the world. The document
has been subject to consultation throughout its development.

There are no restrictions on the reproduction, distribution or use o f this document; however,
incorporation o f this document, in part or in whole, into any other document, or its translation
into languages other than English, does not convey or represent an endorsement o f any kind by
the International Medical Device Regulators Forum.

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Introduction

The purpose o f this IMDRF guidance is to provide globally harmonized labelling principles for
medical devices, including in vitro diagnostic (IVD) medical devices, and support the IMDRF
Essential Principles o f Safety and Performance'. Specifically, this document provides guidance
on the content o f the label, instructions for use, and information intended for the patient in order
to support the safe and effective use o f medical devices and IVD medical devices by their
intended users.

This document has been developed to encourage and support global convergence o f regulatory
systems. It is intended for use by Regulatory Authorities (RAs), Conformity Assessment Bodies
(CABs), industry, and others, and will provide benefits in establishing consistent labelling
requirements in various jurisdictions. Country-specific requirements for the content o f the
labelling should be kept to the minimum and, where they currently exist, eliminated as the
opportunity arises.

Labelling serves to identify a device and its manufacturer, and to communicate information on
safety, use, and performance. In some jurisdictions, “labelling” is referred to as “information
supplied by the manufacturer”. Labelling includes the label, instructions for use, and
information related to the identification, technical description, intended purpose and proper use
o f the medical device and IVD medical device, as applicable (Figure 1). It is intended for users
o f medical devices and IVD medical devices, both professional and lay persons, as appropriate,
and for relevant third parties.

Figure 1. Elements of Medical Device and IVD Medical Device Labelling

RAs require and specify information that manufacturers are expected to incorporate in the
labelling when the device is placed onto the market, to ensure the safe and effective use o f their
product. This guidance provides some o f those basic expectations, although RAs may have
additional labelling requirements beyond the scope of this guidance.

' See IMDRF/GRRP WG/N47 FIN AL:2018 Essential Principles o f Safety and Performance o f Medical Devices and
IVD Medical Devices

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This guidance document describes the general labelling principles for medical devices and IVD
medical devices and supersedes an earlier version produced under the Global Harmonization
Task Force (GHTF) entitled, “Label and Instructions for Use” dated September 16, 2011
(GHTF/SG1/N70:2011). The intent o f this document is to outline the foundational labelling
principles that are globally harmonized. Depending on the RA having jurisdiction and the
particular medical device or IVD medical device, there may be additional labelling requirements
that may need to be met.

1.0 Scope
This document applies to all medical devices, including IVD medical devices, and is intended to
specify the general content and format o f medical device and IVD medical device labelling in
paper or electronic format. This document provides general labelling principles, including
specific sections on the label, instructions for use, and information intended for the patient. The
requirements o f any relevant medical device or IVD medical device-specific standards should
also be considered.

While this document includes general labelling principles, it does not include sections that
address other possible elements o f labelling. Advertising and promotional materials may be
considered elements o f labelling by some RAs having jurisdiction, but they are outside the scope
of this document. Individual jurisdictions may have their own regulations or requirements
regarding other labelling elements or advertising and promotional materials.

2.0 References
• GHTF/SG1/N78:2012 Principles o f Conformity Assessmentfo r Medical Devices
• GHTF/SGl/N055:2009 Definitions o f the Terms Manufacturer, Authorised
Representative, Distributor and Importer
• GHTF/SGl/N046:2008 Principles o f Conformity Assessment fo r In Vitro Diagnostic
(IVD) Medical Devices
• GWTVIS G \fH ^ l\\2 0 \2 Definition o f the Terms ‘Medical D evice’ and ‘In Vitro
Diagnostic (IVD) Medical Device ’
• IMDRF/UDI WG/N7:2013 UDIGuidance Unique Device Identification (UDI) o f
Medical Devices
• IMDRF/GRRP WG/N47:2018 Essential Principles o f Safety and Performance o f
Medical Devices and IVD Medical Devices
• IMDRF/RPS WG/N19:2016 Common Data Elements fo r Medical Device Identification
• IMDRF/SaMD WG/NIO FINAL:2013 Software as a Medical Device (SaMD): Key
Definitions
• IMDRF/PMD WG/N49 FINAL:2018 Definitions for Personalized Medical Devices
• GSl General Specification:
http://www.gsl.org/docs/gsmD/barcodes/GSl General Specifications.pdf

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Health Industry Business Communications Council (HIBCC)UDI and Labeling Resource

Center: http://www.hibcc.org/udi-resources/

Standards
ISO 639-1:2002 Codes fo r the Representation o f Names o f Languages - Part 1: Alpha-2
Code
ISO 3864-1:2011 Graphical Symbols. Safety Colours and Safety Signs. Part 1: Design
Principles fo r Safety Signs and Safety Markings
ISO 8601:2004 Data Elements and Interchange Formats - Information Interchange -
Representation o f Dates and Times.
ISO 13485:2016 Medical devices —Quality management systems —Requirements fo r
regulatory purposes
ISO 15223-1:2016 Medical Devices —Symbols to be Used with Medical Device Labels,
Labelling and Information to be Supplied —Part 1: General Requirements
ISO 14971:2012 Medical Devices - Application o f Risk Management to Medical Devices
lEC 62366-1:2015 Medical Devices - Part 1: Application o f the Usability Engineering
Process to Medical Devices
ISO/IEC 646:1991 Information Technology - ISO 7-bit Coded Character Set fo r
Information Interchange
ISO/IEC 15415:2011 Information Technology - Automatic Identification and Data
Capture Techniques. Bar Code Symbol Print Quality Test Specification - Two-Dimensional
Symbols
ISO/IEC 15416:2016 Automatic Identification and Data Capture Techniques - Bar code
Print Quality Test Specification - Linear Symbols
ISO/IEC 15426-1:2006 Information Technology- Automatic Identification and Data
Capture Techniques - Bar Code Verifier Conformance Specification — Part I: Linear
Symbols
ISO/IEC 15426-2:2015 Information Technology-Automatic Identification and Data
Capture Techniques - Bar code verifier conformance specification — Part 2: Two-
Dimensional Symbols
ISO/IEC 15459-2:2015 Information technology - Automatic Identification and Data
Capture Techniques - Unique Identification, Part 2: Registration Procedures
ISO/IEC 15459-4:2014 Information Technology - Automatic Identification and Data
Capture Techniques - Unique Identification, Part 4: Individual Products and Product
Packages
ISO/IEC 15459-6:2014 Information Technology - Automatic Identification and Data
Capture Techniques - Unique Identification, Part 6: Groupings
ISO/IEC 16022:2006 Information Technology-Automatic Identification and Data Capture
Techniques-Data Matrix Bar Code Symbology Specification
ISO/IEC TR 29158:2011 Information technology - Automatic identification and data
capture techniques - Direct Part Mark (DPM) Quality Guideline

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• ISO/IEC 18000-6:2013 Information Technology —Radio Frequency Identification fo r Item

Management - Part 6: Parameters fo r Air Interface Communications at 860 MHz to 960
MHz
• ISO 18113:2009 In vitro diagnostic medical devices — Information supplied by the
manufacturer (labelling)

3.0 Deflnitions

3.1 Analytical Performance o f an IVD Medical Device: The ability o f an IVD medical device
to detect or measure a particular analyte. (GHTF/SG5/N6:2012)

3.2 Catalog Number: The value given by the manufacturer to identify the specific medical
device as it relates to its form/fit, function and process (i.e., manufacturing processes
requiring differentiation for the end user). (Adapted from IMDRF/RPS WG/N19:2016)

3.3 Conformity Assessment Body (CAB): A body other than a Regulatory Authority engaged in
determining whether the relevant requirements in technical regulations or standards are
fulfilled. (IMDRF/GRRP WG/N40:2017)

3.4 Contraindication: Labelling elements that describe situations, such as patient populations,
medical reasons, or clinical conditions, in which the device should not be used because the
risk o f use clearly outweighs any possible benefit.

3.5 Clinical Investigation: Any systematic investigation or study in or on one or more human
subjects, undertaken to assess the safety and/or performance o f a medical device. This
term is synonymous with ‘clinical trial’ and ‘clinical study’. (GHTF/ SG5/N1R8:2007)

3.6 Clinical Performance: The ability o f a medical device to achieve its intended purpose as
claimed by the manufacturer. (GHTF/SG5/N1 R8:2007)

3.7 Clinical Performance o f an IVD Medical Device: The ability o f an IVD medical device to
yield results that are correlated with a particular clinical condition/physiological state in
accordance with target population and intended user. (Adapted from GHTF/SG5/N6:2012)

NOTE: Clinical performance can include but is not necessarily limited to diagnostic
sensitivity and diagnostic specificity based on the known clinical/physiological state o f the
individual, and negative and positive predictive values based on the prevalence o f the
disease.

3.8 Electronic Labelling: Any form o f labelling content provided in an electronically

accessible form supplied by the manufacturer related to a medical device or IVD medical
device.

3.9 Expected Lifetime/Expected Service Life: Time-period specified by the manufacturer during
which the medical device or IVD medical device is expected to maintain safe and effective

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use.

NOTE 1: The expected lifetime can be determined by stability or by other methods.

NOTE 2: Maintenance, repairs, or upgrades (e.g. safety or cybersecurity modifications) can

be necessary during the expected lifetime.

3.10 Expiry Date/Expiration Date: Upper limit o f the time interval during which the safety and
performance characteristics o f a material stored under specified conditions can be assured.

NOTE 1: This also applies to medical devices whose physical, chemical or functional
properties are maintained during a specified and known period, such as for capital
equipment.

NOTE 2: Expiry dates are assigned to IVD reagents, calibrators, control materials and other
components by the manufacturer, based on experimentally determined stability properties.

(Adapted from ISO 18113-1:2009)

3.11 Hazard: Potential source o f harm. (ISO/IEC Guide 51:2014)

3.12 Indications fo r Use: A general description o f the disease or condition the medical device or
IVD medical device will diagnose, treat, prevent, cure, or mitigate, including a description
of the patient population for which the medical device or IVD medical device is intended.

3.13 Information fo r Safety. Information provided to the user or responsible organization that is
used as a risk control measure or disclosure o f a residual risk.

NOTE: Examples can include warnings or precautions, instructions in the use of a medical
device or IVD medical device to prevent use error or avoid a hazardous situation, or
explanation o f a safety feature o f a medical device or IVD medical device.

3.14 Intended U se/Intended Purpose'. The objective intent regarding the use o f a product,
process or service as reflected in the specifications, instructions and information provided
by the manufacturer. (Modified from GHTF/SG1/N77:2012)

NOTE 1: The intended use/intended purpose are also part o f promotional or sales materials
or statements, although these materials lie outside the scope o f this document.

NOTE 2: The intended use can include the indications for use.

3.15 Instructions fo r Use: General and technical information provided by the manufacturer to
inform the user o f the medical device or IVD medical device’s intended purpose and
proper use and o f any contraindications, warnings, or precautions to be taken. It is
provided by the manufacturer to support and assist the device users in its safe and
appropriate use. (GHTF/SGl/N70:2011)

NOTE: Instructions for use can also be referred to as “package insert.”

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3.16 In Vitro Diagnostic (IVD) Medical Device: ‘In Vitro Diagnostic (IVD) medical device’
means a medical device, whether used alone or in combination, intended by the
manufacturer for the in-vitro examination of specimens derived from the human body
solely or principally to provide information for diagnostic, monitoring or compatibility
purposes.

NOTE 1: IVD medical devices include reagents, calibrators, control materials, specimen
receptacles, software, and related instruments or apparatus or other articles and are used,
for example, for the following test purposes: diagnosis, aid to diagnosis, screening,
monitoring, predisposition, prognosis, prediction, determination o f physiological status.

NOTE 2: In some jurisdictions, certain IVD medical devices may be covered by other
regulations.

(GHTF/SG1/N71:2012)

3.17 Label: Written, printed, or graphic information either appearing on the medical device
itself, or on the packaging o f each unit, or on the packaging o f multiple devices.
(GHTF/SG1/N70:2011)

NOTE: The definition above refers to the human readable label.

3.18 Labelling: The label, instructions for use, and any other information that is related to
identification, technical description, intended purpose and proper use o f the medical
device, but excluding shipping documents. (GHTF/SG1/N70:2011)

NOTE 1: Labelling can also be referred to as “information supplied by the manufacturer.”

NOTE 2: Labelling can be in printed or electronic format and may either physically
accompany the medical device or direct the user to where the labelling information can be
accessed (such as through a website), as permitted by regulatory jurisdiction.

3.19 Lay User: Individual who does not have formal training in a relevant field or discipline.
(Adapted from GHTF/SG1/N046:2008)

NOTE 1: Principles for lay person(s) may also apply to self-testing for an IVD medical
device.

NOTE 2: For an IVD medical device for self-collection or self-testing, a self-collector or

self-tester is considered a lay user.

3.20 Lot Number. A set o f numbers and/or letters that specifically identifies a medical device or
IVD medical device batch and permits its manufacturing, packaging, labelling and
distribution history to be traced. (Adapted from ISO 18113-1:2011)

NOTE: This can also be referred to as the lot code, batch number, or batch code.

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3.21 Manufacturer: “Manufacturer” means any natural or legal person^ with responsibility for
design and/or manufacture o f a medical device with the intention o f making the medical
device available for use, under their name; whether such a medical device is designed
and/or manufactured by that person themselves or on their behalf by another person(s).
(GHTF/SG1/N055:2009)

NOTE 1: This ‘natural or legal person’ has ultimate legal responsibility for ensuring
compliance with all applicable regulatory requirements for the medical device in the
countries or jurisdictions where it is intended to be made available or sold, unless this
responsibility is specifically imposed on another person by the Regulatory Authority
within that jurisdiction.

NOTE 2: The manufacturer’s responsibilities are described in other GHTF and IMDRF
guidance documents. These responsibilities include meeting both pre-market requirements
and post-market requirements, such as adverse event reporting and notification of
corrective actions.

NOTE 3: ‘Design and/or manufacture’, as referred to in the above definition, may include
specification development, production, fabrication, assembly, processing, packaging,
repackaging, labelling, relabelling, sterilization, installation, or remanufacturing o f a
medical device; or putting a collection of devices, and possibly other products, together for
a medical purpose.

NOTE 4: Any person who assembles or adapts a medical device that has already been
supplied by another person for an individual patient, in accordance with the instructions for
use, is not the manufacturer, provided the assembly or adaptation does not change the
intended use o f the medical device.

NOTE 5: Any person who changes the intended use of, or modifies, a medical device
without acting on behalf o f the original manufacturer and who makes it available for use
under his own name, should be considered the manufacturer o f the modified medical
device.

NOTE 6: An authorized representative, distributor or importer who only adds its own
address and contact details to the medical device or the packaging, without covering or
changing the existing labelling, is not considered a manufacturer.

NOTE 7: To the extent that an accessory is subject to the regulatory requirements o f a

medical device^, the person responsible for the design and/or manufacture o f that accessory
is considered to be a manufacturer.

3.22 Medical Device: Any instrument, apparatus, implement, machine, appliance, implant,
reagent for in vitro use, software, material or other similar or related article, intended by

^ The term “person” that appears here and in the other definitions o f this document, includes legal entities such as a
corporation, a partnership or an association.

^ See GHTF/SG1/N29 Information Document Concerning the Definition o f the Term "Medical Device ”

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the manufacturer to be used, alone or in combination, for human beings, for one or more of
the specific medical purpose(s) of:
• diagnosis, prevention, monitoring, treatment or alleviation o f disease,
• diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury,
• investigation, replacement, modification, or support of the anatomy, or o f a physiologi­
cal process,
• supporting or sustaining life,
• control o f conception,
• cleaning, disinfection or sterilization o f medical devices,
• providing information by means o f in vitro examination o f specimens derived from
the human body;

and does not achieve its primary intended action by pharmacological, immunological, or
metabolic means, in or on the human body, but which may be assisted in its intended
function by such means.

Note: Products which may be considered to be medical devices in some jurisdictions but
not in others include:
• cleaning and disinfection substances,
• aids for persons with disabilities,
• devices incorporating animal and/or human tissues,
• devices for in-vitro fertilization or assisted reproduction technologies.
(Adapted from GHTF/SG1/N71:2012)

NOTE 1: For clarification purposes, in certain regulatory jurisdictions, devices for

cosmetic/aesthetic purposes are also considered medical devices.

NOTE 2: For clarification purposes, in certain regulatory jurisdictions, the commerce o f

devices incorporating human tissues is not allowed.

3.23 Model'. The name and/or number used to represent one medical device, or a family of
medical devices to group many variations that have shared characteristics. (IMDRF/RPS
WG/N 19:2016)

3.24 Packaging'. Product to be used for the containment, protection, handling, delivery, storage,
transport and presentation o f goods, from raw materials to processed goods, from the
producer to the user or consumer, including processor, assembler or other intermediary.
(150 21067-1:2016)

3.25 Patient: An individual under the care o f a healthcare provider who may benefit from the
action o f a medical device. A patient may also be a user o f a medical device.

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3.26 Performance: The ability o f a medical device to achieve its intended purpose as stated by
the manufacturer. Performance may include both clinical and technical aspects.

3.27 Performance o f an IVD Medical Device: The ability of an IVD medical device to achieve
its intended use/intended purpose as claimed by the manufacturer. The performance o f an
IVD medical device consists o f the analytical and, where applicable, the clinical
performance supporting the intended use o f the IVD medical device.
(GHTF/SG5/N6:2012)

3.28 Personalized Medical Device ', a generic term to describe any o f the types o f devices that
are intended for a particular individual, which could be either a custom-made, patient-
matched, or adaptable medical device. (IMDRF/PMD WG/N49)

3.29 Precaution: Information regarding any special care users should exercise for the safe and
effective use o f the device or IVD device, or to avoid damage to the device or IVD medical
device that could occur as a result o f use, including misuse (Adapted from ISO 18113-1).

3.30 Regulatory Authority (RA): A government body or other entity that exercises a legal right
to control the use or sale o f medical devices within its jurisdiction, and that may take
enforcement action to ensure that medical products marketed within its Jurisdiction comply
with legal requirements. (IMDRF/GRRP WG/N40:2017)

3.31 Risk: Combination o f the probability o f occurrence o f harm and the severity o f that harm.
(ISO/IEC Guide 51:2014)

3.32 Residual Risk: Risk remaining after risk reduction measures have been implemented.
(ISO/IEC Guide 51:2014).

3.33 Freedom from unacceptable risk. (ISO/IEC Guide 51:2014)

3.34 Serial Number: A unique sequence o f numbers or letters in a series used to identify an
individual unit o f a medical device (IMDRF/RPS WG/N 19:2016).

3.35 S e lf Testing: Use o f a medical device or IVD medical device by a lay user who is
responsible for collecting the data or specimen, by themselves and on themselves, relying
solely on the instructions provided by the manufacturer. This use can also include
performing the test and interpreting the results by themselves and on themselves.

NOTE: Self-testing may include a third-party caregiver

(Modified from IMDRF/GRRP WG/N47:2018)

3.36 Shelf-Life'. Period o f time until the expiry date during which a medical device or IVD
medical device in its original packaging maintains its stability under the storage conditions
specified by the manufacturer.

NOTE: Stability (3.38) and expiry date (3.10) are related concepts

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(Adapted from ISO 18113-1:2009)

3.37 Single Use Device: A medical device or IVD medical device that is intended to be used on
an individual patient during or for a single procedure and then disposed of. It is not
intended to be reprocessed and used again.

3.38 Stability: Ability o f a medical device and IVD medical device to maintain its safety and
performance characteristics within the manufacturer’s specifications over a specified
period o f time.

NOTE 1: Stability applies to

- Sterile and non-sterile medical devices whose physical, chemical or functional
properties may be altered or compromised over a stated time interval;
- IVD reagents, calibrators and controls, when stored, transported and used in
the conditions specified by the manufacturer,
- Reconstituted lyophilized materials, working solutions and material removed
from sealed containers, when prepared, used and stored according to the
manufacturer’s instructions for use,
- Measuring instruments or measuring systems after calibration.
NOTE 2: Stability o f an IVD reagent or measuring system is normally quantified with
respect to time and specified conditions
- In terms o f the duration o f a time interval over which a measured property
changes by a stated amount; or
In terms o f the change o f a property under specified conditions.

(Adapted from ISO 18113-1:2009)

3.39 Unique Device Identifier (UDI): The UDI is a series o f numeric or alphanumeric
characters that is created through a globally accepted device identification and coding
standard. It allows the unambiguous identification o f a specific medical device on the
market. The UDI is comprised o f the UDI-DI and UDI-PI. (IMDRF/UDI WG/N7: 2013)

NOTE: The word "Unique" does not imply serialization o f individual production units.

3.40 User: The person, professional or lay, who uses a medical device. The patient may be that
user. (GHTF/SGI/N070:2011)

3.41 Warning: Statement that alerts users about a situation that, if not avoided, could result in
hazards or other serious adverse consequences from the use o f a medical device or an IVD
medical device. (Adapted from ISO 18113-1:2009)

4.0 Principles for Medical Device and IVD Medical Device Identification
Medical devices and IVD medical devices may be identifiable in multiple ways, as described
below. The ways in which identifier information should be included in the labelling are

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discussed in subsequent sections o f this document.

4.1 The medical device or IVD medical device should be identified through the use o f a brand
or trade name that allows differentiation from other products o f the same or similar type.

4.2 A medical device or IVD medical device, or a combination o f medical devices or IVD
medical devices or accessories, should be distinguishable from other devices via use o f a
catalog number, or another method that allows identification o f the device model and its
distinguishing characteristics. Each catalog number should only involve one defined
product specification.

4.3 If required by the RA having jurisdiction, a medical device or IVD medical device should
be identified with a Unique Device Identifier (UDI) in human- and machine-readable form.
For implantable devices, the UDI should be identifiable and able to be scanned prior to
implantation. For further guidance on the information to be incorporated within the label
for UDI purposes, the content o f the information to be captured in the UDI, the inclusion
o f UDI information in the UDI database, and the linkage o f UDI with clinical, industry,
and government databases, refer to the IMDRF guidance document on this subject*.

5.0 General Labelling Principles for Medical Devices and IVD Medical
Devices

This section describes the general principles that apply equally to all medical devices and IVD
medical devices. The primary purpose o f labelling is to identify the medical device or IVD
medical device and its manufacturer, and provide essential information about its safety,
performance, and appropriate use to the user or other relevant persons. Such information may
appear on the device itself, on packaging, or as instructions for use. These documents should be
developed and evaluated using risk management principles^ and usability engineering processes^.
Certain jurisdictions may require the inclusion o f additional information or the use o f specific
formatting.

The following principles are recommended.

5.1 Labelling

5.1.1 The medium, format, content, legibility, and location o f the labelling should be
appropriate to the particular medical device or IVD medical device, its intended

^ For additional guidance refer to IM D RF/U D I W G/N7 FIN A L:2013 Unique Device Identification (UDI) o f Medical
Devices
^ For additional guidance refer to ISO 14971:2007 Medical Devices —Application o f Risk Management to Medical
Devices
®For additional guidance refer to lEC 62366-1:2015 Medical Devices —Part 1: Application o f the Usability
Engineering Process to Medical Devices

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purpose, and intended users to ensure safe and appropriate use, taking into
consideration the following:

• user knowledge;

• user training;

• any special needs o f the persons for whom the device is intended; and

• the location and environment in which the device can be used.

5.1.2 Labelling should be subject to document (version) control principles.

5.1.3 Depending on the requirements o f the RA having jurisdiction, labelling may be

provided in one or more language(s). Languages may be identified using the plain
text name o f the language or a language code^.

5.1.4 The use o f internationally recognized symbols* in labelling is encouraged, provided

that device safety is not compromised by a lack o f understanding on the part o f the
user. Where the meaning o f the symbol is not obvious to the user, e.g. for a newly
introduced symbol, an explanation should be provided within the labelling.

5.1.5 Residual risks that are to be communicated to the user and/or other persons should
be included in the labelling and are considered to be information for safety.

5.1.6 If required by the RA having jurisdiction, the labelling should include a summary o f
the performance studies and clinical investigations used to demonstrate
conformance with regulatory review principles and that demonstrate the safety and
clinical performance o f the medical device or IVD medical device for its intended
use. This summary should include but may not be limited to a summary of the
investigation, clinical performance and outcome data, clinical safety information,
and a summary o f the clinical benefit, and should be presented in such a way as to
accurately reflect the safety and performance o f the medical device or IVD medical
device. If not contained in the instructions for use, a reference should be included
as to where such information may be accessed.

5.1.7 The labelling should not contain any language regarding the manufacturer’s liability
in the case o f damage or injury resulting from any use or malfunction o f the
medical device or IVD medical device that contradicts the laws or regulations in the
jurisdiction o f use.

’ For additional guidance refer to ISO 639-1:2002.

®Such as those found in ISO \S223-\’.2Q\6 Medical devices ~~Symbols to be used with medical device labels,
labelling and information to be supplied -- Part 1: General requirements (ISO 7000, lEC 60417)

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5.1.8 The labelling should not contain any disclaimers related to the safety and
performance o f the medical device or IVD medical device for its intended purpose
that are incompatible with the laws or regulations in the jurisdiction o f use, or the
obligations o f the manufacturer to design and manufacture a product that is safe and
performs as intended throughout its expected lifetime.

5.2 Label

The label should contain the following information, which may appear on the medical device or
IVD medical device itself, on the packaging o f each unit, or on the packaging o f multiple
medical devices or IVD medical devices. It is important to note that medical device and IVD
medical device kits may include individual reagents, articles, or medical devices that may be
made available as separate medical devices or IVD medical devices. In this situation, those
individual medical devices and IVD medical devices contained in the kit should comply with the
label content principles in this section.

5.2.1 The information required on the label should be provided in a label on the device
itself. If this is not practicable or appropriate (for example, for small-size devices,
contact lenses, bone cement, software, etc.), some or all the information may appear
on the packaging for each unit, and/or on the packaging o f multiple devices. If UDI
is required by the RA having jurisdiction, it should follow the requirements o f the
appropriate UDI-issuing agency/entity. The UDI should be on the label and on all
device packages, and, for reprocessed devices intended to be used more than once,
it should be provided on the device itself.

5.2.2 The label on the outside packaging should include any special handling measures or
permissible environmental conditions (e.g., upper and lower temperature limits,
light, humidity) for storage and transport o f the medical device or IVD medical
device. Where premature unpacking o f a medical device or IVD medical device or
its parts could result in an unacceptable risk, the label should be marked
appropriately. The use o f non-specific temperature or humidity indications that are
open to interpretation, or which may vary according to geographic location is to be
avoided unless further qualification is included (e.g., “store at room temperature,
i.e.l5-25°C” or “store in a cool place below 15°C, do not freeze”).

5.2.3 Where relevant, the label on the packaging should include an indication o f the net
quantity o f contents, expressed in terms o f weight or volume (including volume
after reconstitution), numerical count, or any combination o f these or other terms
which accurately reflects the contents o f the package.

5.2.4 The label should contain the brand or trade name o f the medical device or IVD
medical device.

5.2.5 The label should contain the details necessary for a user to identify the device and
its use, e.g. ‘cardiac ablation catheter 10 French / 20 cm’ or ‘pediatric thermometer’

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or ‘blood glucose meter’ or ‘HIV-l/HIV-2 antibody test’.

5.2.6 The label should be provided in a human-readable format but may be supplemented
by machine-readable forms, such as radio-frequency identification (RFID) or bar
codes^.

5.2.7 There should be only one machine-readable format on the label. If there are
multiple, there should be a clear indication to anyone relying on capture/use o f this
format throughout distribution and use, including the provider o f care, which
machine-readable format to scan when and for what purpose.

5.2.8 If a catalog number is used to identify the medical device or IVD medical device,
the label should include this catalog number.

5.2.9 The label should contain the name and address o f the manufacturer in a format that
is recognizable and allows the location of the manufacturer to be established. The
address should contain information related to the physical location such as
street/road, number/floor/house, city, state/region, postal code, country, etc. An
abbreviated version o f the address may be sufficient on the label if providing the
full address on the label is not practical, and if the device includes instructions for
use that provide a full address. If permitted by the RA having jurisdiction, this
principle may be fulfilled with a URL on the label that when accessed contains the
full address o f the manufacturer in a format that is recognizable and allows the
location o f the manufacturer to be established.

5.2.10 If an authorized representative is acting on behalf o f the manufacturer in the

country/jurisdiction, the label should also contain the address o f the authorized
representative, if such information is required by the RA having jurisdiction. This
information may be added by the authorized representative within the country of
import rather than be provided by the manufacturer, in which case the additional
information should not obscure any o f the manufacturer's labels. If permitted by the
RA having jurisdiction, this principle may be fulfilled with a URL on the label that
when accessed contains the full address o f the authorized representative in a format
that is recognizable and allows the location o f the authorized representative to be
established.

5.2.11 For imported medical devices or IVD medical devices, the label should contain the
name and physical address o f the importer or distributor within the importing
country/jurisdiction, if such information is required by the RA having jurisdiction.
This information may be added by the importer or distributor within the country o f
import rather than be provided by the manufacturer, in which case the additional
information should not obscure any o f the manufacturer's labels.

^ For additional guidance refer to IMDRF/UDI WG/N7 FINAL:20I3 Unique Device Identification (UDI) o f
Medical Devices

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5.2.12 If the label includes symbols and safety-related identification colors^^ the marking
should be explained, where necessary.

5.2.13 The label should include the batch code, batch number, lot code, lot number, serial
number, control number, or version number o f the medical device or IVD medical
device, as appropriate.

5.2.14 The label should include an unambiguous indication o f the date, such as the expiry
date, after which the medical device or IVD medical device cannot be used safely,
where this is relevant (e.g. on devices supplied sterile or single-use disposable
devices). Ideally, this date should be expressed as the full year, month, and day
because this format provides the least ambiguity. The label should also include the
date o f manufacture, if required by the RA having jurisdiction. In this case, the date
o f manufacture may be included as part of the batch or serial number, provided the
date is clearly identifiable.

5.2.15 If the medical device or IVD medical device is supplied sterile, the label should
include an indication that the device is provided in a sterile state and, where
applicable, the sterilization method.

5.2.16 Where appropriate, the label should state that the medical device or IVD medical
device contains or incorporates a medicinal or biological substance, e.g. heparin-
coated catheter or drug-coated stent. If required by the RA having jurisdiction, the
label should also include the quantity, proportion or strength o f that substance (e.g.
contains lOmg/ml sodium hyaluronate; gentamicin (2%)) if the substance will be in
direct contact with the patient.

5.2.17 The label should include any warnings or precautions to be taken that need to be
brought to the immediate attention o f the user o f the medical device or IVD medical
device as relevant, and to any other person where appropriate (e.g. ‘CAUTION -
HOT SURFACE’ or ‘THIS PRODUCT CONTAINS LATEX’ or ‘CONTAINS
POTENTIALLY INFECTIOUS MATERIAL’). This information may be kept to a
minimum, such as through the use o f symbols, in which case more detailed
information should appear in the instructions for use.

5.2.18 The label should indicate if the medical device or IVD medical device is intended
by the manufacturer for single-use only or reuse on a single patient. The label may
indicate reuse in more than one patient if warranted. If the medical device or IVD
medical device is reusable and its reusability is limited, the label should indicate
these limitations (e.g., maximum number o f allowable reuses).

5.2.19 The label should indicate if the medical device or IVD medical device is intended
only for premarket clinical investigation, premarket performance evaluation, non-
clinical research, or presentation or demonstration purposes. In these situations.

For additional guidance see ISO 3864-1:2011 Graphical Symbols. Safety Colours and Safety Signs. P arti:
Design Principles fo r Safety Signs and Safety Markings

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some o f the principles listed in this document may not apply.

Labels should be durable and legible for at least the lifetime o f the medical device or IVD
medical device.

5.3 Instructions for Use

5.3.1 Instructions for use should be written in terms readily understood by the intended
user and, where appropriate, supplemented with drawings and diagrams near the
corresponding text. Some medical devices or IVD medical devices may include
separate information for the professional user and the lay person.

5.3.2 Where the manufacturer supplies multiple medical devices or IVD medical devices
to a single user and/or location, it may be sufficient to provide only a single copy of
the instructions for use. In these circumstances, the manufacturer should provide
further copies upon request or make the instructions for use available in an
electronic format.

5.3.3 Instructions for use may not be needed or may be abbreviated for certain medical
devices or IVD medical devices if they can be used safely and as intended by the
manufacturer without any such instructions for use. Justification for any omission
should be described in the manufacturer’s risk analysis for the medical device or
IVD medical device.

5.3.4 Instructions for use may be provided to the user in paper or electronic format or
both, as permitted by the RA having jurisdiction. They may be supplied by various
means either with the medical device or IVD medical device or separate from it.
Examples o f other means are: information displayed on a screen incorporated into
the medical device or IVD medical device, information downloaded from the
manufacturer’s website, and machine-readable sources. The means chosen should
be appropriate for the use environment and accessible to the anticipated user
population. Any updates to the instructions for use need to be consistent across
paper and electronic formats whether they are retrospective or batch specific.

5.3.5 If the manufacturer has a website, the instructions for use may also be made
available on that website. In this situation, the medical device or IVD medical
device packaging should include a means for the user to easily access the
appropriate electronic instructions for use via inclusion o f a web address or other
information.

5.3.6 Where instructions for use are provided on a medium other than paper, the
manufacturer should ensure the user has information on how to:

• view the instructions for use;

• access the correct version o f the instructions for use; and

• obtain a paper version o f the instructions for use.

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NOTE: The RA having jurisdiction may set the conditions for when the electronic
instructions for use should be provided to guarantee a high level o f safety. These
conditions may specify the types o f medical devices or IVD medical devices that
can use electronic instructions for use and the requirements the manufacturer needs
to follow. For example, the RA may specify that the manufacturer should upon
request provide a paper version free o f charge.

5.3.7 The instructions for use should contain the name or trade name o f the medical
device or IVD medical device.

5.3.8 The instructions for use should include a description o f the medical device or IVD
medical device and how it is intended to be used.

5.3.9 The instructions for use should contain the name and address o f the manufacturer in
a format that is recognizable and allows the location o f the manufacturer to be
established, together with contact information (e.g., telephone number, fax number,
website or email address) to obtain technical assistance, if such information is
required by the RA having jurisdiction.

5.3.10 The instructions for use should state the medical device’s or IVD medical device’s
intended use/purpose, including the indications for use, intended user (e.g.
professional or lay person), and intended use environment, as appropriate.

5.3.11 The instructions for use should state the performance o f the medical device or IVD
medical device claimed by the manufacturer.

5.3.12 The instructions for use should include any specifications the user requires to use,
process, and maintain the device appropriately. For example, if the medical device
or IVD medical device performs any measurements, the instructions for use should
include the claimed limits o f accuracy.

5.3.13 The instructions for use should include information that allows the user and/or
patient to be sufficiently informed o f any warnings, precautions, measures to be
taken and limitations o f use regarding the medical device or IVD medical device.
This information should cover, where appropriate:

a) warnings, precautions and/or measures to be taken in the event o f malfunction o f

the medical device or IVD medical device or changes in its functionality that
may affect safety or performance;

b) warnings, precautions and/or measures to be taken in regard to the exposure to

reasonably foreseeable external influences or environmental conditions, such as
magnetic fields, external electrical and electromagnetic effects, electrostatic
discharge, radiation associated with diagnostic or therapeutic procedures,
pressure, humidity, or temperature;

c) warnings, precautions and/or measures to be taken in regard to the risks of

interference posed by the reasonably foreseeable presence o f the medical device

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or IVD medical device during specific diagnostic investigations, evaluations,

therapeutic treatment or use (e.g. electromagnetic interference emitted by the
device affecting other equipment);

d) precautions related to materials incorporated into the device that are potentially
carcinogenic, mutagenic or toxic, or could result in sensitization or allergic
reaction for the patient or user; and

e) precautions related to potentially infectious material that is included in a medical

device or IVD medical device.

5.3.14 The instructions for use should include any recommended quality control
procedures to be taken to verify that the medical device or IVD medical device
performs as intended, including the following if applicable:

a) the procedures for using any available controls;

b) instructions recommending the frequency o f use;

c) the limitations o f the quality control procedure;

d) how the user should interpret the quality control procedure results, including a
description o f whether test results can or cannot be accepted; and

e) the actions to be taken if there is a failure o f any o f the controls.

5.3.15 If the medical device or IVD medical device incorporates or includes a medicinal or
biological substance, the instructions for use should identify that substance or
material, and list any warnings, precautions and/or limitations related to this
substance. If required by the RA having jurisdiction, the instructions for use should
also include the quantity, proportion or strength o f that substance if the substance
will be in direct contact with the patient.

5.3.16 The instructions for use should include information describing the purpose and
interpretation o f any indicators (e.g., humidity, temperature) provided within the
packaging, and what steps to take based on the indicator results.

5.3.17 The instructions for use should identify information for safety including any
relevant residual risks, contraindications, and any expected and foreseeable adverse
events, including information to be conveyed to the patient in this regard.

5.3.18 The instructions for use should include the details o f any preparatory treatment or
handling o f the medical device or IVD medical device before it is ready for use
(e.g., sterilization, identification of other necessary equipment not provided with the
medical device or IVD medical device, final assembly, reconstitution, calibration).

5.3.19 The instructions for use should include any requirements for special facilities (e.g.
sterile field or clean room environment), or special training, or particular

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qualifications o f the user and/or third parties.

5.3.20 The instructions for use should contain any information needed to verify that the
medical device or IVD medical device is properly installed and ready to perform
safely and as intended by the manufacturer, including when applicable:

a) details and frequency o f preventive and regular maintenance;

b) cleaning and disinfection information

c) identification o f consumable components and how to replace them;

d) necessary calibration information; and

e) methods for mitigating risks encountered during cleaning, installation,

calibration or servicing.

5.3.21 The instructions for use should include any special handling measures or
permissible environmental conditions (e.g., upper and lower temperature limits,
light, humidity) for storage and transport o f the medical device or IVD medical
device. The use o f non-specific temperature or humidity indications that are open
to interpretation, or which may vary according to geographic location is to be
avoided unless further qualification is included.

5.3.22 The instructions for use should include any warnings or precautions to be taken
related to the disposal o f the medical device or IVD medical device and its
accessories. This also includes any consumables that require special disposal as a
result o f being used with the medical device or IVD medical device. This
information should cover, where appropriate:

a) infection or microbial hazards (e.g. explants, needles or surgical equipment

contaminated with potentially infectious substances o f human origin);

b) environmental hazards (e.g. batteries or materials that emit potentially

hazardous levels o f radiation); and

c) physical hazards (e.g. Irom sharps),

5.3.23 If the medical device or IVD medical device is supplied sterile, the instructions for
use should include instructions to be followed in the event o f the sterile packaging
being damaged or unintentionally opened before use.

5.3.24 The instructions for use should include any instructions to be followed in the event
o f the packaging being damaged or unintentionally opened before use, or if the
packaging is exposed to environmental conditions outside o f those specified.

5.3.25 If the medical device or IVD medical device is supplied non-sterile with the
intention that it is sterilized before use, the instructions for use should include

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appropriate instructions for sterilization and should also include any instructions for
cleaning the device prior to sterilization.

5.3.26 If the medical device or IVD medical device is reusable, the instructions for use
should include information on the appropriate processes to allow reuse, including
cleaning, disinfection, packaging and, where appropriate, the method o f re­
sterilization. Information should be provided to identify when the device should no
longer be reused (e.g., signs o f material degradation or the maximum number of
allowable reuses).

5.3.27 For medical devices or IVD medical devices intended for use together with other
medical devices, IVD medical devices, and/or general purpose equipment, the
instructions for use should include sufficient information identify such devices or
equipment, in order to obtain a safe combination, and/or information on any known
restrictions to combinations o f medical devices or IVD medical devices and
equipment.

5.3.28 If the medical device or IVD medical device emits hazardous, or potentially
hazardous levels o f radiation for medical purposes, the instructions for use should
include detailed information as to the nature, type and where appropriate, the
intensity, distribution, and recommended dose o f the emitted radiation; and/or the
means o f protecting the patient, user, or third party from unintended radiation
during use o f the device.

5.3.29 The instructions for use should state the date o f issue or latest revision o f the
instructions for use and, where appropriate, an identification number.

6.0 General Labelling Principles for Medical Devices other than IVD Medical
Devices

In addition to the principles outlined in Section 5.0, medical devices should also meet the
following labelling principles.

6.1 Label

6.1.1 The label should indicate if the medical device is for use by a single individual and
has been manufactured according to a written prescription or pattern (e.g., it is a
personalized medical device).

6.2 Instructions for Use

6.2.1 If the medical device administers medicinal or biological products, the instructions
for use should indicate any limitations or incompatibilities in the choice of
substances to be delivered.

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7.0 General Labelling Principles for IVD Medical Devices

In addition to the principles outlined in Section 5.0, IVD medical devices should also meet the
following labelling principles.

7.1 Label

7.1.1 The label should state that the IVD medical device is for in vitro diagnostic use.

7.2 Instructions for Use

7.2.1 The description o f the intended use should include the following, where applicable:

a) what the IVD medical device measures or detects;

b) its function (e.g. screening, monitoring, diagnosis or aid to diagnosis, prognosis,

prediction, companion diagnostic);

c) the specific disorder, condition or risk factor o f interest that it is intended to

detect, define or differentiate;

d) whether or not it includes automated components or is intended to be used with

automated instruments;

e) what the IVD medical device reports (e.g., qualitative test, semi-quantitative,
quantitative test);

f) the type o f specimen(s) (e.g. serum, plasma, whole blood, tissue biopsy, urine)
required including the specimen source(s) (e.g. capillary whole blood from
arm), matrix (e.g. EDTA tube), time (e.g. 8 hours after injury) and collection
method (e.g. self-collected urine); and

g) target population (on whom the IVD medical device is used).

7.2.2 The instructions for use should include a statement o f the test principle(s), such as
the general biological, chemical, microbiological, immunochemical and other
principles on which the IVD medical device is based. Proprietary information need
not be disclosed, but should provide enough detail to allow the user to understand
how the IVD medical device is able to carry out its function.

7.2.3 The instructions for use should include a description and the amount o f the reagent,
calibrators and controls and any limitation upon their use (e.g. suitable for a
dedicated instrument only).

NOTE: IVD medical device kits include individual reagents and articles that may
be made available as separate IVD medical devices. In this situation, where
appropriate, these IVD medical devices should comply with the instructions for use

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content in this section.

7.2.4 The instructions for use should include a list o f materials provided and a list o f any
materials required but not provided. ^

7.2.5 The instructions for use should include a description o f in-use stability. This may
include the storage conditions prior to opening and shelf-life following the first
opening o f the primary container, together with the storage conditions and stability
of working solutions, where this is relevant.

7.2.6 The instructions for use should list the included and excluded conditions for
collection, shipping, handling, and preparation o f the specimen.

7.2.7 Where relevant, the instructions for use should include the traceability o f values
assigned to calibrators and trueness-control materials, including identification of
applicable reference materials and/or reference measurement procedures o f higher
order.

7.2.8 The instructions for use should describe the assay procedure including calculations
and interpretation o f results, any additional software or reference database required,
and where relevant, if any confirmatory testing should be considered.

7.2.9 The instructions for use should list the analytical performance characteristics, such
as precision, accuracy, sensitivity, and specificity.

7.2.10 Where relevant, the instructions for use should list the clinical performance
characteristics (e.g. diagnostic sensitivity, diagnostic specificity, positive predictive
value, negative predictive value, likelihood ratio, expected values in normal and
affected populations).

7.2.11 Where relevant, the instructions for use should include the reference intervals in
normal and affected populations.

7.2.12 The instructions for use should include information on any interfering substances or
limitations (e.g. visual evidence o f hyperlipidemia or hemolysis, age of
specimen/sample) that may affect the performance o f the assay.

7.2.13 Where relevant, the instructions for use should include a bibliography or references
section.

8.0 Labelling Principles for Medical Devices Containing Software or Software

as a Medical Device
8.1 Software that is incorporated into a medical device or IVD medical device or that is
intended for use as software as a medical device (SaMD) should be identified with an
identifier, such as version, revision level or date o f build release/issue. The unique

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identifier should be accessible to the intended user, unless the medical device does not
have a wired or wireless electronic interface.

8.2 For software incorporated into a medical device or IVD medical device, the identifier does
not need to be on the outside o f the medical device or IVD medical device.

8.3 For SaMD without a physical form or packaging, the label may be available electronically.
In this situation, the medical device should incorporate a means for the user to easily
access the electronic label via the software itself or via inclusion o f a web address or other
means.

9.0 Labelling Principles for Medical Devices and IVD Medical Devices
Intended for Use by Lay Persons

9.1 The information and instructions provided by the manufacturer should allow the intended
lay user to understand and apply, in order to correctly interpret the result provided by the
device or to confirm that the device is operating or has operated as intended.

9.2 Instructions for use intended to be used principally by lay users should be available in a
format appropriate and accessible to the lay user.

9.3 Some devices may include separate information for the professional user and the lay
person, e.g. a simplified job aid for lay persons. This information should agree with the
instructions for use and should state clearly the version it relates to. It should be written at
a level consistent with the education, training and any special needs o f its intended readers.

9.4 The language o f the intended use statement may be simplified in instructions for use used
by lay persons (including self-testing), provided key messages remain. In addition,
instructions for use for home use medical devices or self-testing IVD medical devices may
omit some o f the recommended elements, provided this does not affect safety or
performance. Justification for any omission should be described in the manufacturer’s risk
analysis for the product.

9.5 Interpretation o f results should include pictorial representations o f all possible test results
(including when a device has failed to provide a valid result) for medical devices or IVD
medical devices that give a visual readout, where applicable.

9.6 For medical devices or IVD medical devices intended for use by lay persons, the
instructions for use should clearly and concisely describe the circumstances when the user
should consult with a healthcare professional.

9.7 Instructions for use should clearly state if an IVD medical device is intended for self­
testing. Self-testing may include the involvement o f a third-party caregiver.

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10.0 Labelling Principles for Information Intended for the Patient

The following principles are not related to the use o f a medical device or IVD medical device by
a lay person, but instead describe general considerations for information intended to be provided
to the patient before or after use o f the medical device or IVD medical device by a professional.

Not all medical devices or IVD medical devices include information to be provided to the
patient. The need for such information and the applicability o f the principles below depend on
the RA havingjurisdiction and the type o f medical device, including implantable devices in
certain regulatory jurisdictions.

10.1 Infomation that is specifically intended for the patient should be provided with the
medical device or IVD medical device. Depending on the device, the user population and
the RA jurisdiction, it may be appropriate for this information to be available
electronically. In this situation, the medical device or IVD medical device should include a
means for the patient to easily access the electronic information via inclusion o f a web
address or other information.

10.2 Information identifying the device should be provided in a human-readable format but may
be supplemented by machine-readable forms, such as bar codes. If UDI is required by the
RA havingjurisdiction, UDI should be included.

10.3 If the information intended for the patient includes an implant card, the card should be in a
durable format and should include the following:

a) identification o f the medical device, including the brand or trade name and the device
type or use, e.g. ‘transcatheter heart valve’ or ‘synthetic hernia mesh’;

b) identification o f the device model;

c) the catalog number;

d) the number used to uniquely identify the medical device, such as the lot number, serial
number, or UDI; and

e) the name and address o f the manufacturer and any authorized representative or
importer in a format that is recognizable and allows their location to be established. A
fiill address should contain information related to the physical location such as
street/road, number/floor/house, city, state/region, postal code, country, etc.

10.4 If the information intended for the patient includes an informational brochure, the
information in the brochure should be written in a way that is readily understood by
patients. In addition, the brochure should include the following information, as well as any
other information relevant to the device or recommended in specific standards, as
applicable:

a) the name o f the medical device;

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b) the model o f the medical device;

c) the intended use, including the intended purpose and patient population;

d) any special operating instructions for the use o f the medical device;

e) a description o f the medical device, its mechanism o f action, and its expected
performance;

f) any adverse event the patient may potentially experience due to the medical device;

g) warnings about any relevant residual risks;

h) warnings about risks that could arise from the interaction o f the medical device with
other equipment, and precautions and other measures that should be taken by the
patient or a health professional because o f these risks;

Example I ; The risk o f electrical interference from electro surgical medical devices.

Example 2: The risk o f magnetic field interference from magnetic resonance imaging
medical devices.

i) the nature and frequency o f regular or preventive examination, monitoring, or

maintenance o f the medical device that should be undertaken;

j) the nature and frequency o f any follow-up with healthcare professionals to be

performed by the patient;

k) signs that could indicate that the medical device is malfunctioning;

l) precautions and other measures that should be taken by the patient if the performance
o f the medical device changes or the patient experiences any o f the signs mentioned in
item (k);

m) the expected lifetime o f the medical device, and any factors that could affect it;

n) precautions and other measures that should be taken at, or near, the end o f the
expected lifetime;

o) information about the materials and substances, including manufacturing residuals, in

the medical device that could pose a risk to the patient;

p) contact information for the manufacturer;

q) circumstances in which the patient should contact a health professional; and

r) guidance regarding whom the patient should contact in the case o f any symptoms o f an
adverse event or a problem with the device.

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