ISO 20417:2026 Medical devices — Information to be supplied by the manufacturer

Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).

ISO draws attention to the possibility that the implementation of this document may involve the use of (a) patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a) patent(s) which may be required to implement this document. However, implementers are cautioned that this may not represent the latest information, which may be obtained from the patent database available at www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.

Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO’s adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.

This document was prepared by Technical Committee ISO/TC 210, Quality management and corresponding general aspects for products with a health purpose including medical devices, in collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/CLC/JTC 3, Quality management and corresponding general aspects for medical devices, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).

This second edition cancels and replaces the first edition (ISO 20417:2021), which has been technically revised.

The main changes are as follows:

Any feedback or questions on this document should be directed to the user’s national standards body. A complete listing of these bodies can be found at www.iso.org/members.html.

Introduction

This document provides general requirements for the identification and labelling of a medical device or accessory that appears on the packaging, is marked on the medical device or accessory and is contained in the accompanying information. The aim of this document is to serve as a central source of these common, generally applicable requirements, allowing each specific product standard or group standard to focus more concisely on the unique requirements for a specific medical device or group of medical devices.

The requirements of a medical device product standard or a group standard can make use of these general requirements to simplify those documents. Additional specific product information requirements can be set out in specific product standards or group standards. Unless specified otherwise within a product standard or a group standard, the general requirements of this document apply.

This document has been prepared in consideration of:

This document is organized in a structured manner. Clause 4 contains general process requirements. Clause 5 contains the information that needs to be established to support creating the information supplied by the manufacturer such as units of measurements, how to identify languages and countries and how to express dates and addresses. It also contains the requirements regarding the identification of medical devices and accessories, such as items like a catalogue number, unique identification of software version, production control identifier, a consistent indication of use/reuse and sterilization state. Clause 6 contains the requirements for the accompanying information of medical devices and accessories. This includes the requirements for the packaging, the label and marking of medical devices and accessories, as well as the instructions for use and technical description.

In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the conditions is true.

In this document, the following verbal forms are used:

Requirements in this document have been decomposed so that each requirement is uniquely delineated. This is done to support automated requirements tracking.

1 Scope

NOTE 1

There is guidance or rationale for this Clause in A.2.1.

This document specifies the requirements for information supplied by the manufacturer for a medical device or an accessory, as defined in 3.1. This document includes the generally applicable requirements for identification and labels on a medical device or accessory, the packaging, marking of a medical device or accessory, and accompanying information. This document does not specify the means by which the information is to be supplied.

NOTE 2

Some authorities having jurisdiction impose different requirements for the identification, marking and documentation of a medical device or accessory.

Specific requirements of medical device product standards or group standards take precedence over requirements of this document.

2 Normative references

The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

• ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code
• ISO 7000 Graphical symbols for use on equipment — Registered symbols
• ISO 7010 Graphical symbols — Safety colours and safety signs — Registered safety signs
• ISO 14971:2019 Medical devices — Application of risk management to medical devices
• ISO 15223-1:2021 Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements
• ISO 15223-1:2021/Amd 1:2025 Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements — Amendment 1: Addition of defined term for authorized representative and modified EC REP symbols to not be country or region specific
• IEC 60417 (database), Graphical symbols for use on equipment
• ISO 80000-1 Quantities and units — Part 1: General

3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 14971:2019 and the following apply.

ISO and IEC maintain terminology databases for use in standardization at the following addresses:

NOTE

An alphabetized index of defined terms used in this document is found in Annex E.

3.1 accessory

3.2 accompanying information

information supplied by the manufacturer (3.15) with or marked (3.22) on a medical device (3.23) or accessory (3.1) for the user (3.49) or responsible organization (3.33), particularly regarding safe use

The accompanying information is regarded as part of the medical device or accessory.

The accompanying information can consist of the label (3.18), marking (3.22), instructions for use (3.16), technical description (3.43), information shown on the packaging or graphical user interface (GUI), installation manual, quick reference guide, etc. and can address the installation, use, processing (3.31), maintenance and disposal of the medical device or accessory.

Accompanying information is not necessarily a written or printed document but can involve auditory, visual, or tactile materials and multiple media types (e.g. CD-ROM, DVD-ROM, USB stick, website).

Medical devices and accessories that can be used safely without accompanying information are exempted from having accompanying information by some authorities having jurisdiction (3.4).

See Figure 1.

Figure 1

NOTE 1

The label (3.18) can include the information on the packaging of the medical device (3.23) or accessory (3.1).

NOTE 2

e-documentation (3.9) can include any or all types of information supplied by the manufacturer partially or entirely.

NOTE 3

‘Marketing information’ is also known as ‘promotional material’.

3.3 applicable policy

3.4 authority having jurisdiction

3.5 authorized representative

3.6

^a

value given by the manufacturer to identify a specific medical device (3.23) or accessory (3.1) as it relates to its form, fit, function and process

A catalogue number can relate to manufacturing processes requiring differentiation for the end user (3.49).

A catalogue number only consists of letters or numbers or a combination of these.

A commercial product code is different from the product coding of an authority having jurisdiction (3.4) (e.g. US FDA ‘product code’ or procode classification).

See Figure 2.

Adapted from Reference [23].

Figure 2

 

^a

At least one of these conditional distinct product identifiers is required.

3.7 clearly legible

3.8 distributor

3.9 e-documentation

3.10 essential principles

3.11 expected lifetime

3.12 group standard

3.13 importer

3.14 information for safety

3.15 information supplied by the manufacturer

3.16 instructions for use

3.17 IVD medical device

3.18 label

3.19 lay, adj

3.20 lot

3.21 lot number

3.22 marking

3.23 medical device

3.24 medical device family

3.25 model number

3.26 multiple patient multiple use

3.27 normal use

3.28 organization

3.29 patient

3.30 pictogram

3.31 processing

3.32 product standard

3.33 responsible organization

3.34 safety sign

3.35 serial number

3.36 service personnel

3.37 shelf-life

3.38 single patient multiple use

3.39 single use

3.40 stability

3.41 sterile

3.42 symbol

3.43 technical description

3.44 UDI carrier

3.45 usability

3.46 usability engineering

3.47 use environment

3.48 use specification

3.49 user

4 General considerations

1. a) The risk management process of ISO 14971:2019 and the usability engineering process of IEC 62366-1:2015+AMD1:2020 should be used to determine the information, including information for safety, to be provided in the information supplied by the manufacturer.

   NOTE 1

   Medical device-specific standards can require additional information supplied by the manufacturer.

2. b) Information supplied by the manufacturer shall be in a language that:
   • 1) is appropriate to the intended user;
   • 2) conforms with the applicable policy.

     NOTE 2

     More than one language can be required in some jurisdictions.

3. c) The accompanying information shall specify:
   • 1) special skills, special training and special knowledge required of the intended user or the responsible organization that are necessary to be able to achieve the intended use of the medical device.
   • 2) if applicable, restrictions on the use environment where the medical device is intended to be used.
4. d) The information supplied by the manufacturer shall be written and presented in terms that are readily understood by the intended users, taking into account their education, training and any special needs, as appropriate.

NOTE 3

Medical device-specific standards can require additional usability requirements.

Check conformity by inspection of the information supplied by the manufacturer.

5.1 Units of measurement

1. a) Numeric indications of parameters in the information supplied by the manufacturer shall be expressed in:
   • 1) international system of units (SI) as specified in ISO 80000-1;
   • 2) any other units required by a relevant group standard or product standard; or
   • 3) any other units established by clinical convention.
2. b) For application of SI units, their multiples and certain other units, ISO 80000-1 shall apply.

Check conformity by inspection of the information supplied by the manufacturer.

5.2 Graphical information

1. a) Unless the applicable policy does not require graphical information to be explained, any graphical information that is replacing text such as pictograms, symbols, safety signs and safety-related identification colours used in the information supplied by the manufacturer shall have the meaning explained in the accompanying information.
2. b) Symbols used in the information supplied by the manufacturer should be found in:
   • 1) ISO 7000 (database);
   • 2) ISO 7010;
   • 3) ISO 15223-1:2021+Amd 1:2025;
   • 4) IEC 60417 (database);
   • 5) IEC/TR 60878:2015; or
   • 6) if applicable:
     1. i) relevant product standards; or
     2. ii) relevant group standards.
3. c) Symbols should be used in the information supplied by the manufacturer.

Check conformity by inspection of the information supplied by the manufacturer and by inspection of the accompanying information.

5.3.1 Language identifiers

1. a) In multilingual information supplied by the manufacturer, the language name used should be clearly linked to the language used.
2. b) In multilingual information supplied by the manufacturer, the language name used may be identified using:
   • 1) the plain text name of the language; or
   • 2) the language codes in accordance with ISO 639 (see https://standards.iso.org/iso/639/ed-2/en/).
     EXAMPLE 1

     In an English section: ‘English’ or ‘en’ or ‘eng’.

     EXAMPLE 2

     In a French section: ‘Français’ or ‘fr or ‘fra’.

     EXAMPLE 3

     In a Russian section: ‘Русский’ or ‘ru’ or ‘rus’.

Check conformity by inspection of the information supplied by the manufacturer.

5.3.2 Country identifiers

Where contact details for multiple countries are provided in the information supplied by the manufacturer, the country shall be identified using:

1. a) the country codes given in ISO 3166-1; or
2. b) the plain text of the country name in a language of that country.

Check conformity by inspection of the information supplied by the manufacturer.

5.4 Dates

Unless applicable policy requires a different format for dates, any human-readable date, other than the text associated with the UDI carrier, in the information supplied by the manufacturer shall be expressed in the format^[5^]:

1. a) YYYY-MM-DD;
2. b) YYYY-MM; or
3. c) YYYY;

Check conformity by inspection of the information supplied by the manufacturer.

5.5 Full address

1. a) Where this document refers to a full address, the address shall contain the following elements insofar as they are available in the address system of the locale where the relevant organization (manufacturer, distributor, importer or authorized representative) is physically located:
   • 1) street/road;
   • 2) number/house/floor;
   • 3) city;
   • 4) state/region;
   • 5) postal code;
   • 6) country.
2. b) The information regarding street/road and number/house/floor may be omitted if a postal code (corporate postal code) is used that fully replaces the indication of street/road and number/house/floor and is not a post office (PO) box number.

Check conformity by inspection of the information supplied by the manufacturer.

5.6 Model number

1. a) A model number may be used to represent a medical device, an accessory or a medical device family that have shared characteristics.
2. b) A model number may be associated with multiple catalogue numbers.
3. c) The model number may be identical to the catalogue number, when there is a single catalogue number represented by the model number.

5.7 Catalogue number

1. a) A medical device or accessory, or a combination of medical devices or accessories, may be identified with a catalogue number.
2. b) Each unique catalogue number shall be related to a single, defined product specification.
3. c) Multiple catalogue numbers may be associated with a single model number.

Check conformity by inspection of the information supplied by the manufacturer.

5.8 Production control identifiers

1. a) A production control identifier associated with a medical device shall be identified by at least one of the following:
   • 1) lot number;
   • 2) serial number;
   • 3) for medical devices containing cells or tissues, donor identification information;
   • 4) at least the year and month by which it is safe to use; or
   • 5) at least the year and month of manufacture.
2. b) This information shall identify a controlled group of products associated with the production process for identification and traceability.

Check conformity by inspection of the information supplied by the manufacturer.

5.9 Unique device identifier

1. a) Unless the applicable policy does not require a unique device identifier, a medical device or accessory shall be assigned a unique device identifier.
2. b) This identifier shall have a 1:1 relation to:
   • 1) a single catalogue number; or
   • 2) a single model number.

Check conformity by inspection of the information supplied by the manufacturer.

5.10 Types of use/reuse

A unique use classification shall be assigned at the level of model number or catalogue number from one of the following:

1. a) single use;
2. b) single patient multiple use;
3. c) multiple patient multiple use.

Check conformity by inspection of the information supplied by the manufacturer.

5.11 Sterile

1. a) A sterile medical device or accessory shall be identified as sterile.
2. b) A sterile medical device or accessory shall be identified with the method of sterilization.
3. c) A sterile medical device or accessory shall be identified with the sterile barrier configuration.
4. d) Medical devices or accessories available in both sterile and non-sterile versions shall have different:
   • 1) model numbers; or
   • 2) catalogue numbers.

Check conformity by inspection of the information supplied by the manufacturer.

6.1.1 Minimum requirements for the label

1. a) The information required in 6.1 shall be provided as a label.
2. b) The information on the label shall be provided in a human-readable format, except for that required to be machine readable.
3. c) The information required in 6.1 shall be provided as a marking unless:
   • 1) the size of the medical device or accessory does not allow fixation of this information on the medical device or accessory;
   • 2) the nature of the outer surfaces does not allow fixation of this information on the medical device or accessory; or
   • 3) the omission of these markings does not adversely affect the benefit/risk balance according to ISO 14971:2019.
4. d) If the information required in 6.1 is not provided by marking, a justification for the omission shall be documented in the risk management file.

Check conformity by inspection of the label and, if applicable, the marking or risk management file.

6.1.2 Identification of the manufacturer

1. a) The label of a medical device or accessory shall include the name or trade name and, unless otherwise included in the IFU, the full address of
   • 1) the manufacturer, and
   • 2) where the manufacturer does not have an address within the locale and the applicable policy requires a local address, an authorized representative within the locale,
   to which the responsible organization can refer.
2. b) In locales where the manufacturer or their authorized representative is required to be registered, the address used shall be the same as the registered address.
3. c) Symbol ISO 7000-3082 or symbol 5.1.1 from ISO 15223-1:2021 may be used to identify the manufacturer.
4. d) Symbol 5.1.12 from ISO 15223-1:2021/Amd 1:2025 may be used to identify the authorized representative.
   • 1) Where permitted by the applicable policy, the address of the authorized representative may be applied by someone other than manufacturer.
     EXAMPLE 1

     A label applied by the authorized representative and not the manufacturer.

     1. i) An additional label shall not obscure any information on the label provided by the manufacturer.
5. e) The medical device or accessory may be labelled with the country of manufacture using either:
   • 1) a text string; or
     EXAMPLE 2

     Made in CC (where CC is the country code from ISO 3166-1)

   • 2) symbol IEC 60417-6049 or symbol 5.1.11 from ISO 15223-1:2021.

     NOTE

     Some customs authorities having jurisdiction require the country of origin in a text string.

Check conformity by inspection of the label.

6.1.3 Identification of the medical device or accessory

NOTE

There is guidance or rationale for this subclause in A.2.4.

1. a) The label of a medical device or accessory shall include the details necessary for the user to identify:
   • 1) the medical device or accessory;
   • 2) its use.
     EXAMPLE 1

     ‘Drug Eluting Stent’ or ‘Blood Glucose Meter’ or ‘Pulse Oximeter’ or ‘Infusion Pump’.

2. b) The label of a medical device or accessory shall include a distinctive identification.
   • 1) If a model number is used, it shall be identified by:
     1. i) a text string; or
     EXAMPLE 2

     For an English label: ‘Model number xyz123’ or ‘model xyz123’.

     1. ii) symbol IEC 60417-6050.
   • 2) The catalogue number shall be identified by:
     1. i) a text string; or
     EXAMPLE 3

     For an English label: ‘Catalogue number xyz123’.

     1. ii) symbol ISO 7000-2493 or symbol 5.1.6 from ISO 15223-1:2021.
3. c) The medical device or accessory shall be labelled with any special transport, storage or handling conditions to which it can be safely exposed.
   • 1) These special transport, storage or handling conditions may be kept to a minimum.
   • 2) In this case, more detailed information should appear in the information supplied by the manufacturer.
4. d) The medical device or accessory shall be labelled with any special operating instructions that need to be brought to the immediate attention of the user.
   • 1) These special operating instructions may be kept to a minimum.
   • 2) In this case, more detailed information should appear in the instructions for use.
5. e) The medical device or accessory shall be labelled with any necessary warnings or precautions that need to be brought to the immediate attention of the user.
   • 1) These warnings or precautions may be kept to a minimum.
   • 2) In this case, more detailed information should appear in the instructions for use.
6. f) If the medical device or accessory, other than IVD medical devices, contains known allergens as well as phthalates or other hazardous substances, in a concentration that is above 0,1 % weight by weight, that are classified as endocrine disrupting, carcinogenic, mutagenic or toxic to reproduction shall be labelled as containing such substances.
   • 1) The symbol ISO 7000-2725 or symbol 5.4.5 from ISO 15223-1:2021 may be used for latex.
   • 2) The symbol EN 15986:2011 may be used for phthalates.
   • 3) The symbol ISO 7000-3723 or symbol 5.4.10 from ISO 15223-1:2021 may be used for endocrine disrupting, carcinogenic, mutagenic or toxic to reproduction substances.
   • 4) The symbol ISO 7000-2725 may be used for other hazardous substances.
7. g) If some or all of the instructions for use are e-documentation, the medical device or accessory shall be labelled with an indication that electronic instructions for use are available.
   • 1) Electronic instructions for use may be indicated by a text string indicating electronic instructions for use.
   • 2) Electronic instructions for use may be indicated by symbol ISO 7000-1641 or symbol 5.4.3 of ISO 15223-1:2021:
     1. i) with an accompanying electronic-IFU indicator; or
     2. ii) with a web address.
   • 3) Where applicable, the label shall include a reference to the accessibility or availability of this e-documentation.
   • 4) Where required by the applicable policy, the label shall include the website address where the correct instructions for use can be consulted.
8. h) If intended for single use, the medical device or accessory shall be labelled with:
   • 1) a text string indicating ‘do not reuse’;
   • 2) a text string indicating ‘single use only'; or
   • 3) symbol ISO 7000-1051 or symbol 5.4.2 from ISO 15223-1:2021.
9. i) If intended for single patient multiple use, the medical device or accessory shall be labelled with:
   • 1) a text string indicating ‘single patient multiple use’; or
   • 2) symbol ISO 7000-3706 or symbol 5.4.12 from ISO 15223-1:2021.
10. j) If reuse is limited, the medical device or accessory shall be labelled with the limitation on reuse.
    EXAMPLE 4

    The maximum number of allowable reuses or processing cycles.

11. k) If sterile, the medical device or accessory shall be labelled with sterile and identify the method of sterilization.
    • 1) Sterile and the method of sterilization may be identified by a text string.
    • 2) Sterile and the method of sterilization may be identified as applicable, with symbol:
      1. i) ISO 7000-2500 or symbol 5.2.2 from ISO 15223-1:2021;
      2. ii) ISO 7000-2501 or symbol 5.2.3 from ISO 15223-1:2021;
      3. iii) ISO 7000-2502 or symbol 5.2.4 from ISO 15223-1:2021;
      4. iv) ISO 7000-2503 or symbol 5.2.5 from ISO 15223-1:2021; or
      5. v) 5.2.10 from ISO 15223-1:2021; or
      6. vi) ISO 7000-2499 or symbol 5.2.1 from ISO 15223-1:2021 and a text string identifying the method of sterilization.
12. l) If containing biological origin substances, the medical device or accessory shall be labelled as containing biological origin substances.
    • 1) The symbol of ISO 7000-3701 or symbol 5.4.6 from ISO 15223-1:2021 may be used for containing human blood or plasma derivatives.
    • 2) The symbol of ISO 7000-3699 or symbol 5.4.8 from ISO 15223-1:2021 may be used for containing biological material of animal origin.
    • 3) The symbol of ISO 7000-3700 or symbol 5.4.9 from ISO 15223-1:2021 may be used for containing biological material of human origin.
    • 4) Where required by an applicable policy, the label shall also include the quantity, proportion or strength of that substance if the substance will be in direct contact with the patient.
13. m) If containing medicinal substances, the medical device or accessory shall be labelled as containing medicinal substances.
    • 1) The symbol of ISO 7000-3702 or symbol 5.4.7 from ISO 15223-1:2021 may be used for containing medicinal substances.
    • 2) Where required by an applicable policy, the label shall also include the quantity, proportion or strength of that substance if the substance will be in direct contact with the patient.
14. n) If containing nanotechnology materials, the medical device or accessory should be labelled as containing nanotechnology materials.
    • 1) The symbol ISO 7000-3703 or symbol 5.4.11 from ISO 15223-1:2021 may be used for containing nanotechnology materials.

Check conformity by inspection of the label.

6.1.4 Other label requirements

1. a) The label of a medical device or accessory shall include at least one production control identifier.
2. b) The production control identifier may be a lot number.
   • 1) The lot number may be identified by:
     1. i) a text string; or
     2. ii) symbol ISO 7000-2492 or symbol 5.1.5 from ISO 15223-1:2021.
3. c) The production control identifier may be a serial number.
   • 1) The serial number may be identified by:
     1. i) a text string; or
     2. ii) symbol ISO 7000-2498 or symbol 5.1.7 from ISO 15223-1:2021.
4. d) The production control identifier may be at least the year and month by which it is safe to use.
   • 1) The date by which it is safe to use may be identified by:
     1. i) a text string; or
     2. ii) symbol ISO 7000-2607 or symbol 5.1.4 from ISO 15223-1:2021.
5. e) The production control identifier may be at least the year and month of manufacture, for a medical device or accessory without a date by which it is safe to use.
   • 1) The date of manufacture may be identified by:
     1. i) a text string;
     2. ii) symbol ISO 7000-2497 or symbol 5.1.3 from ISO 15223-1:2021; or
     3. iii) symbol ISO 7000-3082 or symbol 5.1.1 from ISO 15223-1:2021.
   • 2) The date of manufacture may be included in the lot number or serial number.
6. f) If a unique device identifier has been assigned, the label of a medical device or accessory shall include a unique device identifier (UDI).
   • 1) If more than one machine readable AIDC is on the label, symbol 5.7.10 from ISO 15223-1:2021 shall be used to identify the UDI carrier.
   • 2) Single use medical devices or accessories need not bear the UDI carrier ‘direct marking’.
7. g) If the medical device or accessory is sterile, the label of a medical device or accessory shall include at least the year and month:
   • 1) by which it is safe to use; or
   • 2) of manufacture, for a medical device or accessory without a date by which it is safe to use.
8. h) If the medical device or accessory is sterile, the date by which it is safe to use may be identified by:
   • 1) a text string; or
   • 2) symbol ISO 7000-2607 or symbol 5.1.4 from ISO 15223-1:2021.
9. i) If the medical device or accessory is sterile, the date of manufacture, for a medical device or accessory without a date by which it is safe to use:
   • 1) may be identified by:
     1. i) a text string;
     2. ii) symbol ISO 7000-2497 or symbol 5.1.3 from ISO 15223-1:2021; or
     3. iii) symbol ISO 7000-3082 or symbol 5.1.1 from ISO 15223-1:2021.
   • 2) may be included in the lot number or serial number.
10. j) The label of a medical device or accessory may include unique version identifier of the label.
11. k) If the medical device, other than an IVD medical device, is for use by a single person and has been manufactured according to a written prescription or pattern (e.g. it is an adaptable medical device or a patient-matched medical device), the label shall indicate that it is for use by a single person.

Check conformity by inspection of the label.

6.1.5 Consult instructions for use

NOTE

There is guidance or rationale for this subclause in A.2.5.

1. a) When the manufacturer uses consulting the accompanying information as a primary risk control measure for a specific risk (e.g. the instructions for use contain information for safety), the medical device or accessory shall be labelled with:
   • 1) the mandatory action safety sign ISO 7010-M002; or
   • 2) a text string to the effect that it is a mandatory action to read the instructions for use.
2. b) Otherwise, symbol ISO 7000-1641 or symbol 5.4.3 from ISO 15223-1:2021 may be used to advise the user to consult the instructions for use.

Check conformity by inspection of instructions for use and the risk management file.

6.1.6 Safety signs

1. a) For the purpose of this subclause, where a safety sign is used to convey a warning, prohibition or mandatory action that mitigates a risk that is not obvious to the user, it shall be a safety sign selected from ISO 7010.
   • 1) The colours for safety signs specified in ISO 7010 are specified in ISO 3864-1 and should use the specified colour.
2. b) If a safety sign with an established meaning is appropriately used, the use of the general warning safety sign ISO 7010-W001 is not required.

   NOTE 1

   In this context, warning is used to mean “There is certain danger”; prohibition is used to mean “You must not…”; and mandatory action is used to mean “You must…”.

3. c) Where a safety sign is not available to indicate a particular desired meaning, the meaning may be obtained by one of the following methods.
   • 1) Constructing a safety sign in accordance with ISO 3864-1:2011.
   • 2) Using the general warning safety sign ISO 7010-W001 placed together with a supplementary symbol or text.
     1. i) The text associated with the general warning safety sign shall be an affirmative statement (i.e. a safety notice) describing the principal risk(s) foreseen (e.g. “Causes burns”, “Risk of explosion”).
   • 3) Using the general prohibition safety sign ISO 7010-P001 placed together with a supplementary symbol or text.
     1. i) The text associated with the general prohibition safety sign shall be a statement (i.e. a safety notice) describing what is prohibited (e.g. “Do not open”, “Do not drop”).
   • 4) Using the general mandatory action safety sign ISO 7010-M001 placed together with a supplementary symbol or text.
     1. i) The text associated with the general mandatory action safety sign shall be a command (i.e. a safety notice) describing required action (e.g. “Wear protective gloves”, “Scrub before entering”).
4. d) When using one of the general safety signs and if there is insufficient space to place the associated statement together with the safety sign on the medical device or accessory, the affirmative statement may be placed in the instructions for use.
5. e) Additionally, a safety notice should include the appropriate precautions or include instructions on how to reduce the risk (e.g. “Do not use for . . . ”, “Keep away from . . .”).
6. f) Safety signs, including any supplementary symbol or text:
   • 1) shall be explained in the instructions for use;
   • 2) if colour is not utilized in the instructions for use, the colour of the safety sign shall be described in the instructions for use.
7. g) When supplementary text is placed together with safety signs, the supplementary text shall be in a language that is:
   • 1) required by the applicable policy;
   • 2) where no such language is required, appropriate to the intended user.

     NOTE 2

     More than one language is required in some jurisdictions.

Check conformity by inspection of the label and, if applicable, the marking and, where applicable, the instructions for use.

6.2 Identification requirements for detachable components of a medical device or accessory

If misidentification can result in an unacceptable risk, detachable components of a medical device or accessory shall be labelled with:

1. a) the name or trademark of the manufacturer.
2. b) a distinctive identification.
   • 1) If a model number is used, it shall be identified by:
     1. i) a text string; or
     EXAMPLE 1

     For an English label: ‘Model number xyz123’ or ‘Model xyz123’.

     1. ii) symbol IEC 60417-6050.
   • 2) If a catalogue number is used, it shall be identified by:
     1. i) a text string; or
     EXAMPLE 2

     For an English label: ‘Catalogue number xyz123’.

     1. ii) symbol ISO 7000-2493 or symbol 5.1.6 from ISO 15223-1:2021.
3. c) a production identifier in accordance with 6.1.4 a).

Check conformity by inspection of the label.

6.3 Legibility of the label

1. a) The label including the markings required in 6.1 shall be clearly legible when viewed from the intended position of the user performing the related function.
2. b) The test method of Annex B may be used to assess legibility.

Check conformity for clear legibility with the results from an appropriate test.

6.4 Durability of markings

1. a) The markings on the medical device or accessory required in 6.1 shall be sufficiently durable to remain clearly legible, as applicable, during the medical device’s or accessory’s:
   • 1) expected lifetime; or
   • 2) shelf-life.
2. b) The markings required in 6.1 shall:
   • 1) remain clearly legible under reasonably foreseeable environmental and mechanical impacts associated with the use of the medical device;
   • 2) be removable only:
     1. i) with an extra-corporeal object that can be used to secure or release a fastener; or
     2. ii) by appreciable force.
3. c) In considering the durability of the markings, the effect of normal use shall be taken into account.
4. d) The test method of Annex C may be used to assess durability.

Check conformity for durability with the results from an appropriate test.

6.5.1 General information

1. a) For the purposes of this document, packaging need not include shipping containers.
2. b) The packaging of a medical device or accessory shall allow the identification of:
   • 1) the name or trade name and address of the manufacturer;
   • 2) where the manufacturer does not have an address within the locale and the applicable policy requires a local address, the name and address of an authorized representative within the locale.
3. c) Where the applicable policy requires unique device identifier, the packaging of a medical device or accessory shall include a unique device identifier (UDI) as specified in 5.10, of the medical device or accessory.
   • 1) If more than one machine readable AIDC is on the label, symbol 5.7.10 from ISO 15223-1:2021 shall be used to identify the UDI carrier.
   • 2) Single use medical devices or accessories need not be marked with a UDI carrier.
4. d) The packaging of a medical device or accessory shall include at least one production control identifier.
5. e) The production control identifier may be a lot number.
   • 1) The lot number may be identified by:
     1. i) a text string; or
     2. ii) symbol ISO 7000-2492 or symbol 5.1.5 from ISO 15223-1:2021.
6. f) The production control identifier may be a serial number.
   • 1) The serial number may be identified by:
     1. i) a text string; or
     2. ii) symbol ISO 7000-2498 or symbol 5.1.7 from ISO 15223-1:2021.
7. g) For medical devices containing cell tissues, the production control identifier may be donor identification information.
8. h) The production control identifier may be at least the year and month by which it is safe to use.
   • 1) The date may be identified by:
     1. i) a text string; or
     2. ii) symbol ISO 7000-2607 or symbol 5.1.4 from ISO 15223-1:2021.
9. i) The production control identifier may be at least the year and month of manufacture for a medical device or accessory without a date by which it is safe to use.
   • 1) The date may be identified by:
     1. i) a text string;
     2. ii) symbol ISO 7000-2497 or symbol 5.1.3 from ISO 15223-1:2021; or
     3. iii) symbol ISO 7000-3082 or symbol 5.1.1 from ISO 15223-1:2021.
10. j) The packaging of a medical device or accessory shall include a distinctive identification.
11. k) If a model number is used for the distinctive identification, it shall be identified by:
    • 1) a text string; or
      EXAMPLE 1

      For English packaging: ‘Model number xyz123’ or ‘model xyz123’.

    • 2) symbol IEC 60417-6050 or symbol 5.1.10 from ISO 15223-1:2021.
12. l) If a catalogue number is used for the distinctive identification, it shall be identified by:
    • 1) a text string; or
      EXAMPLE 2

      For English packaging: ‘Catalogue number xyz123’.

    • 2) symbol ISO 7000-2493 or symbol 5.1.6 from ISO 15223-1:2021.
13. m) If medical device or accessory is intended for single use, the packaging of a medical device or accessory shall indicate:
    • 1) ‘do not reuse’;
    • 2) ‘single use only’ or
    • 3) symbol ISO 7000-1051 or symbol 5.4.2 from ISO 15223-1:2021.
14. n) If medical device or accessory is intended for single patient multiple use, the packaging of a medical device or accessory shall indicate:
    • 1) ‘single patient multiple use'; or
    • 2) symbol ISO 7000-3706 or symbol 5.4.12 from ISO 15223-1:2021.
15. o) Where relevant, the package shall allow the identification of the net quantity of contents, expressed in terms of weight or volume, numerical count, or any combination of these or other terms that accurately reflect the contents of the package.
    • 1) Numerical count may be indicated with symbol ISO 7000-2794.

Check conformity by inspection of the packaging.

6.5.2 Packaging for the lay user

1. a) In addition to the requirements of 6.5.1, if the medical device or accessory is intended to be presented to the lay user for retail sales and is intended for use by a lay user, the sales packaging shall include the following,
   • 1) the ‘statement of intended use’ otherwise known as a summary of use specification, unless the purpose is obvious to the intended lay user (see IEC 62366-1:2015+AMD1:2020).
   • 2) the information needed to select the proper size, if applicable.

     NOTE 1

     There is guidance or rationale for this list item in A.2.6.

   • 3) any special requirements for a battery-powered medical device.
   • 4) any special storage requirements (e.g. temperature and humidity ranges).
   • 5) any necessary contraindications, warnings or precautions that need to be brought to the immediate attention of the user.

     NOTE 2

     For additional information, see IMDRF/GRRP WG/N52:2024^[25^], 5.2.16.

   • 6) safe disposal information for the medical device or accessory, if applicable.
2. b) This information shall be visible under expected conditions of sale.

Check conformity by inspection of the packaging.

6.5.3 Special conditions indicated on the packaging

1. a) If special handling measures have to be taken during transport or storage, the packaging shall allow the identification of these measures accordingly.

   NOTE 1

   Symbols for handling and storage of packages can be found in ISO 780 and ISO 15223-1.

   NOTE 2

   Additional symbols for packages can be found in ISO 7000.

   • 1) These environmental conditions for transport and storage may be identified, as applicable, with the following symbols:
     1. i) ISO 7000-0533 or symbol 5.3.6 from ISO 15223-1:2021;
     2. ii) ISO 7000-0534 or symbol 5.3.5 from ISO 15223-1:2021;
     3. iii) ISO 7000-0624 or symbol 5.3.2 from ISO 15223-1:2021;
     4. iv) ISO 7000-0626 or symbol 5.3.4 from ISO 15223-1:2021;
     5. v) ISO 7000-0632 or symbol 5.3.7 from ISO 15223-1:2021;
     6. vi) ISO 7000-2620 or symbol 5.3.8 from ISO 15223-1:2021; or
     7. vii) ISO 7000-2621 or symbol 5.3.9 from ISO 15223-1:2021.
   • 2) Symbol 3869 from ISO 14617-2:2025 may be added adjacent to the symbols in 1) to indicate transport environmental conditions.
   • 3) Symbol 2066 from ISO 14617-2:2025 may be added adjacent to the symbols in 1) to indicate storage environmental conditions.
2. b) Where premature unpacking of a medical device, accessories or their parts could result in an unacceptable risk, the packaging shall allow identification of a suitable safety sign (see 6.1.6).
   EXAMPLE 1

   Humidity-sensitive or temperature-sensitive medical devices.

   EXAMPLE 2

   Medical devices containing hazardous substances and materials.

3. c) Where providing all of the information required in 6.5.3 a) and 6.5.3 b) is not practicable due to the size of the packaging, the remaining information may be provided in the accompanying information.

Check conformity by inspection of the packaging, and if applicable, the accompanying information.

6.5.4 Sterile packaging

1. a) The packaging of a medical device or accessory supplied sterile shall indicate that the contents are sterile and identify the method of sterilization:
   • 1) Sterile and the method of sterilization may be identified by a text string.
   • 2) Sterile and the method of sterilization may be identified as applicable, with symbol:
     1. i) ISO 7000-2500 or symbol 5.2.2 from ISO 15223-1:2021;
     2. ii) ISO 7000-2501 or symbol 5.2.3 from ISO 15223-1:2021;
     3. iii) ISO 7000-2502 or symbol 5.2.4 from ISO 15223-1:2021;
     4. iv) ISO 7000-2503 or symbol 5.2.5 from ISO 15223-1:2021; or
     5. v) 5.2.10 from ISO 15223-1:2021.
2. b) The packaging of a medical device or accessory supplied sterile shall indicate at least the year and month by which it is safe to use.
   • 1) The date may be identified by:
     1. i) a text string; or
     2. ii) symbol ISO 7000-2607 or symbol 5.1.4 from ISO 15223-1:2021.
3. c) The packaging of a medical device or accessory supplied sterile shall include an indication permitting the sterile packaging to be recognized as such if, at the point of use, the packaging system to be opened consists of more than one packaging layer.
   • 1) The packaging system can be identified, as applicable, with the following symbols:
     1. i) ISO 7000-3704 or symbol 5.2.12 from ISO 15223-1:2021;
     2. ii) ISO 7000-3707 or symbol 5.2.11 from ISO 15223-1:2021;
     3. iii) ISO 7000-3708 or symbol 5.2.13 from ISO 15223-1:2021;
     4. iv) ISO 7000-3709 or symbol 5.2.14 from ISO 15223-1:2021.

     NOTE 1

     The indication permitting the sterile packaging to be recognized as such differentiates between packaging layers that are validated as a sterile-barrier system from packaging layers that support aseptic presentation or protect from dust. This is particularly important for double-entry sterile-barrier systems as risk control for unintended contamination of the sterile field.

     NOTE 2

     Additional information can be found in ISO 11607-1 regarding requirements for multiple-layer sterile-barrier systems and sterile fluid path medical devices or accessories as well as guidance on ways to differentiate a sterile-barrier system from protective packaging.

4. d) The packaging of a medical device or accessory supplied sterile shall include instructions to check the instructions for use for what to do if the sterile packaging is damaged or unintentionally opened before use.
   • 1) When the instructions are to not use the medical device or accessory, symbol ISO 7000-2606 or symbol 5.2.8 from ISO 15223-1:2021 may be used.
5. e) The packaging of a medical device or accessory supplied sterile shall include an indication on the sterile packaging permitting the sterile packaging to be recognised as such.
6. f) Where providing all of the information required in 6.5.4 c) to 6.5.4 e) is not practicable due to the size of the packaging, the remaining information may be provided in the accompanying information.

Check conformity by inspection of the packaging, and if applicable, the accompanying information.

6.6 Requirements for information in the instructions for use and technical description

NOTE

There is guidance or rationale for this subclause in A.2.7.

6.6.1 General

1. a) Unless the medical device or accessory can be used safely and effectively without the instructions for use and the technical description, the accompanying information shall include:
   • 1) the information specified for inclusion in the instructions for use;
   • 2) the information specified for inclusion in the technical description.
2. b) The risk management process of ISO 14971:2019 shall be used to evaluate and justify any omission in the accompanying information of:
   • 1) the instructions for use; or
   • 2) the technical description.
3. c) The information specified for inclusion in the technical description may be included in the instructions for use.
4. d) The accompanying information shall identify the medical device or accessory by including the name or trade name and full address of
   • 1) the manufacturer, and
   • 2) where the manufacturer does not have an address within the locale and the applicable policy requires a local address, an authorized representative within the locale,

1. e) The accompanying information shall identify the medical device or accessory by including contact information of the manufacturer to obtain technical assistance;
   EXAMPLE

   Telephone number, fax number, website or email address.

2. f) The accompanying information shall identify the medical device or accessory by including the identification of the medical device or accessory, including at least one of the following:
   • 1) the medical device family name;
   • 2) the model number;
   • 3) the catalogue number.
3. g) The accompanying information shall identify the medical device or accessory by including a description of the medical device.
4. h) Some medical devices may include separate accompanying information for the professional user and the lay user.
   • 1) In this circumstance, the information for the professional user and the lay user shall be consistent.
   • 2) In this circumstance, the information for the lay user shall clearly state the version of the information for the professional user to which it relates.
5. i) The information shall be created and presented in terms that are readily understood by the intended users, taking into account their education, training and any special needs, as appropriate.
   • 1) Where appropriate, the accompanying information should be supplemented with drawings and diagrams near the corresponding text.
6. j) The accompanying information may be split into multiple elements.
   • 1) If the accompanying information is split into multiple elements, at least one element shall indicate the list of all the elements.

Check conformity by inspection of the accompanying information.

6.6.2 Requirements for instructions for use

1. a) The instructions for use shall include:
   • 1) the general information of 6.6.1.
   • 2) the use of the medical device or accessory as intended by the manufacturer.
   • 3) all information for safety necessary to safely use the medical device or accessory in accordance with its specifications.
   • 4) the ‘statement of intended use’ otherwise known as a summary of the use specification (see IEC 62366-1:2015+AMD1:2020).
     1. i) The language of this statement may be simplified in instructions for use intended for lay users provided key messages remain.
   • 5) the performance of the medical device claimed by the manufacturer.
   • 6) an explanation of any residual risk, including any foreseeable adverse events or side effects associated with the use of the medical device or accessory.
     1. i) This explanation shall include any information that should be conveyed to the patient in this regard.
     2. ii) This explanation shall include that the user should convey this information to the patient.
     3. iii) Residual risks shall be communicated as:

        — limitations;

        — contraindications;

        — precautions; or

        — warnings.

   • 7) any known contraindications to the use of the medical device or accessory.
     1. i) This shall include any information to be conveyed to the patient in this regard.
   • 8) unique version identifier of the instructions for use, such as a date of issue or revision number.
   • 9) if applicable, those parts of the medical device that cannot be safely serviced or maintained while in use with a patient.
   • 10) if applicable, safe disposal information for the medical device, its accessories and the consumables used with it, if any, including where applicable:
     1. i) infection or microbial hazards;
     EXAMPLE 1

     Explants, needles or surgical equipment contaminated with potentially infectious substances of human origin.

     1. ii) environmental hazards;
     EXAMPLE 2

     Batteries or materials that emit potentially hazardous levels of radiation.

     1. iii) physical hazards (e.g. from sharps).
   • 11) if applicable, the details of any preparatory treatment or handling of the medical device before it is ready for use necessary to ensure that the medical device will perform as intended.
     EXAMPLE 3

     Sterilization, identification of other necessary equipment not provided with the medical device, final assembly, reconstitution, calibration.

   • 12) the information contained in 6.1.2, 6.1.3 and 6.5.3.
     1. i) The use of non-specific temperature or humidity indications that are open to interpretation, or that can vary according to geographic location shall be avoided unless further qualification is included.
2. b) The instructions for use should contain only the information most likely to be useful to the user or responsible organization.

   NOTE 1

   The instructions for use are intended for the lay or professional user and the responsible organization to safely and effectively use the medical device to achieve the intended use. Additional details can be contained in the technical description.

3. c) The instructions for use shall include the specifications the user requires to use the medical device or accessory appropriately.
   EXAMPLE 4

   If the medical device has a measuring function, the degree of accuracy claimed.

4. d) The instructions for use shall include information needed to determine whether the medical device or accessory is ready to perform safely and as intended, together with, where relevant:
   • 1) details of any preparatory treatment or handling of the medical device or accessory before it is ready for use or during its use (e.g. final assembly, calibration).
     1. i) This shall include:

        — any necessary information regarding acceptance and performance testing;

        — associated acceptance criteria;

        — any specific position of user or patient during set up or use.

   • 2) details of the nature, and frequency, of preventative and regular maintenance, and of any processing.

     NOTE 2

     See ISO 17664-1 and ISO 17664-2 for additional information about information to be provided concerning processing.

   • 3) identification of any consumable components and how to replace them.
   • 4) information on any necessary calibration to ensure that the medical device or accessory operates properly and safely during the expected lifetime.
   • 5) methods of controlling the risks encountered by users involved in installing, calibrating or servicing the medical device or accessory.
   • 6) any recommended quality control procedures to be taken to verify that the medical device or accessory performs as intended, including the following as applicable:
     1. i) the procedure for using the available controls;
     2. ii) instructions recommending the frequency of use;
     3. iii) the limitations of the quality control procedure, clearly delineated;
     4. iv) how the user should interpret the quality control procedure results, including a description of whether test results can or cannot be accepted when a quality control procedure fails;
     5. v) the actions to be taken if there is a failure of any of the controls.
   • 7) any requirements for special facilities (e.g. sterile field, clean room environment, controlled access area), or special training, or particular qualifications of the user or third parties.
5. e) For medical devices intended for use together with other medical devices or general-purpose equipment, the instructions for use shall include:
   • 1) information to identify such medical devices or equipment in sufficient detail, in order to obtain a safe combination;
   • 2) information on any known restrictions to combinations of medical devices and equipment.
6. f) Where the applicable policy requires clinical benefit disclosure, the instructions for use shall include:
   • 1) a specification of the clinical benefit to be expected;
   • 2) a brief overview of safety and clinical performance information relevant to the user or patient.
7. g) If the medical device or accessory is supplied sterile, the instructions for use shall include instructions to be followed in the event of the sterile packaging being damaged or unintentionally opened before use.
8. h) If the medical device or accessory is supplied non-sterile with the intention that it is sterilized before use, the instructions for use shall include the appropriate processing instructions for sterilization.
9. i) For a medical device or accessory intended for reuse, the instructions for use shall:
   • 1) include the necessary information for the processing between uses;
   • 2) identify when the medical device or accessory can no longer be reused (e.g. signs of material degradation or the maximum number of allowable reuses).
10. j) The instructions for use shall include information of any warnings, precautions, measures to be taken and limitations of use regarding the medical device or accessory.
    • 1) This shall include any information to be conveyed to the patient in this regard.
    • 2) This information should be determined during the risk management process as well as from other relevant group standards and product standards.
    • 3) This information should cover, where applicable:
      1. i) warnings, precautions or measures to be taken in the event of malfunction of the medical device or changes in its performance that can affect safety;
      2. ii) warnings, precautions or measures to be taken in regards 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;
      3. iii) warnings, precautions or measures to be taken in regards to the risks of interference posed by the reasonably foreseeable presence of the medical device during specific diagnostic investigations, evaluations, therapeutic treatment or use (e.g. electromagnetic interference emitted by the medical device affecting other equipment);
      4. iv) precautions related to materials incorporated into the medical device that are endocrine disrupting, carcinogenic, mutagenic or toxic to reproduction or could result in sensitisation or allergic reaction of the patient or user;
      5. v) warnings or precautions related to potentially infectious material present in the medical device;
      6. vi) warnings or precautions for a medical device administering medicinal or biological products, including information that indicates any limitations or incompatibility in the type of substances to be delivered;
      7. vii) warnings, precautions or measures to be taken in regards to calibration and maintenance requirements that could result in inaccurate measurements, diagnostic results or therapeutic treatment or use;
      8. viii) warnings or precautions on hazardous or potentially hazardous radiation, including

         — the nature of the emitted radiation,

         — the means of protecting the users, bystanders, or where appropriate, patients,

         — the ways of avoiding misuse, and

         — the ways of appropriately reducing the risks inherent during transport, storage and installation where applicable.

11. k) The instructions for use shall instruct the user and the patient to report any serious incident that has occurred in relation to the medical device to the manufacturer and the authority having jurisdiction in their locale.
12. l) Where multiple medical devices are provided to a single user or location, the manufacturer may provide a single copy of the instructions for use.
    • 1) In this circumstance, the manufacturer should provide further copies upon request or make the instructions for use available as e-documentation.
13. m) If the medical device incorporates or includes a medicinal or biological substance, the instructions for use shall identify that substance or material.
    • 1) In this circumstance, the instructions for use should also include the quantity, proportion or strength of that substance if the substance will be in direct contact with the patient.
14. n) If any indicators (e.g. humidity, temperature, shock) are provided within the packaging, the instructions for use shall include information describing:
    • 1) their purpose and interpretation;
    • 2) what steps to take based on the indicator results.
15. o) The instructions for use shall include any applicable instructions to be followed in the event of the packaging being:
    • 1) damaged;
    • 2) unintentionally opened before use;
    • 3) if the packaging is exposed to environmental conditions outside of those specified.
16. p) For medical devices or accessories with electronic displays, text on those displays intended for the user shall be clearly legible.
17. q) If the medical device, other than an IVD medical device, administers medicinal or biological products, the instructions for use shall indicate any limitations or incompatibilities in the choice of substances to be delivered.
18. r) If the medical device emits hazardous, or potentially hazardous levels of radiation for medical purposes, the instructions for use shall include detailed information as to:
    • 1) the nature of the emitted radiation;
    • 2) the type of the emitted radiation;
    • 3) ways of avoiding misuse and of appropriately reducing the risks inherent to transport, storage and installation, and,
    • 4) where applicable,
      1. i) the intensity of the emitted radiation,
      2. ii) the distribution of the emitted radiation,
      3. iii) the recommended dose of the emitted radiation, and
      4. iv) means of protecting the patient, the user, or a third party from unintended radiation during use of the medical device.

Check conformity by inspection of the instructions for use and, where applicable, evaluation of the electronic display.

6.6.3 Additional requirements for the instructions for use for a lay user

1. a) Where the patient is an intended user, the instructions for use shall identify, as applicable:
   • 1) that the patient is an intended user; or
   • 2) that the medical device is intended for self-testing.

     NOTE 1

     For a medical device where the intended use includes the patient partially or fully operating the medical device, the patient becomes a user.

2. b) Where the intended user is a lay user, the instructions for use shall identify, where applicable:
   • 1) clearly and concisely the circumstances when the user should consult with a healthcare professional provider;
   • 2) a warning against servicing and maintenance while the medical device is in use;
   • 3) which functions the lay user can safely use;
   • 4) which functions the lay user cannot safely use;
   • 5) which maintenance the lay user can perform (e.g. changing batteries).

     NOTE 2

     For a medical device where the lay user is allowed to perform restricted maintenance, the lay user becomes service personnel.

3. c) Where the intended user is a lay user, the instructions for use shall be available in a format appropriate and accessible to the lay user.
4. d) Where the intended user is a lay user, the instructions for use shall be written at:
   • 1) the lower secondary education level^[27^]; or
   • 2) another education level appropriate to the intended lay user specified in the use specification.
5. e) Where the intended user is a lay user, the instructions for use shall allow the intended lay user:
   • 1) to understand and apply, in order to correctly interpret, the result provided by the medical device; or
   • 2) to confirm that the medical device is operating or has operated as intended.
6. f) Where applicable and the intended user is a lay user, the instructions for use shall include pictorial representations of all possible results (including when a medical device has failed to provide a valid result) for medical devices that give a visual readout.
7. g) Where the intended user is a lay user and the intended use environment includes home use, the instructions for use may omit some of the recommended elements of 6.6.2, provided this does not affect safety or performance.
   • 1) The justification for any omission shall be evaluated in accordance with ISO 14971:2019.

Check conformity by inspection of the instructions for use and, if applicable, the risk management file.

6.6.4 Requirements for technical description

1. a) The technical description shall include if separate from the instructions for use:
   • 1) the general information of 6.6.1;
   • 2) the information in 6.6.2 a) 2);
   • 3) the information in 6.6.2 a) 3);
   • 4) the information in 6.6.2 a) 4).
2. b) The technical description shall include information regarding any:
   • 1) acceptance and performance testing;
   • 2) recurrent testing and maintenance, including details of the means, methods and recommended frequency;
3. c) The technical description shall include all critical characteristics of the medical device, as well as range and precision of all the measured or displayed values or performances or an indication where they can be found.
4. d) The technical description shall include a unique version identifier such as a date of issue or revision number.
5. e) The technical description shall provide all data that is essential for safe use, transport and storage, maintenance or repair, and measures or conditions necessary for installing the medical device and preparing it for use.
6. f) For a medical device with a wireless or wired electronic interface, the technical description shall include at least all of the following, as applicable:
   • 1) the purpose of the electronic interface including any medical devices, equipment, interface standard/specification, or software (including the unique identifier of the software) with which it is meant to connect.
   • 2) the intended user of the interface.
   • 3) whether the connection is meant to control the operations of another medical device or accessory.
   • 4) the communication format (protocol) including:
     1. i) the specifications for the interface (e.g. physiological waveforms, probe type or types, accuracy, frequency of response, update rate, data rate, bandwidth);
     2. ii) the necessary performance and functional requirements from the medical device related to the sending or receiving of data or control;
     3. iii) interface relevant standards used (including revision or date);
     4. iv) if applicable, a list of services provided (i.e. application program interfaces or APIs).
   • 5) the necessary interface specifications.
     EXAMPLE

     Security needs for integration; type of physical connection; requirements for integrity; performance and functional requirements like accuracy, frequency of response, update rate, data rate and quality of service or QoS (bandwidth, latency, jitter/wander, time synchronization).

   • 6) the list of the data attributes being exchanged or a reference to the standard defining the data attributes.
   • 7) a summary of the testing performed on the interface to verify interoperability claims and any activities suggested for the responsible organization to verify safe use.
     1. i) In the case where testing was performed to an interface specification and verified with a representative medical device, the manufacturer should specify the representative medical device used.
   • 8) any method used for time synchronization.

     NOTE 1

     There is guidance or rationale for this list item in A.2.8.

   • 9) a description of any fault tolerance behaviour, boundary condition testing, or fail safe for critical functions (e.g. delivering energy) that allows the user to understand how to use the interface correctly;
   • 10) any known limitations (what the user should not do), contraindications, precautions and warnings.
   • 11) the recommended connections:
     1. i) the equipment with which the interface is intended to be connected; or
     2. ii) that interface is meant to be connected to unspecified equipment.
   • 12) any recommended settings or configurations for the electronic interface.
   • 13) list options for training or necessary qualifications for IT personnel, if applicable.
   • 14) where the electronic interface is intended to connect to an IT network:
     1. i) the required characteristics of the IT network;
     2. ii) the required configuration of the IT network;
     3. iii) the technical specifications of the IT network connection including security specifications;
     4. iv) the intended information flow between electronic interface, the IT network and other equipment on the IT network, and the intended routing through the IT network;
     5. v) a list of any hazardous situations resulting from a failure of the IT network to provide the characteristics required to meet the purpose of the electronic interface connection to the IT network.
   • 15) the instructions for specific users such as IT personnel on how to connect or install and how to disconnect or uninstall the medical device.
   • 16) where the electronic interface is intended to connect to an IT network, the instructions to the responsible organization that:
     1. i) connection of the electronic interface to an IT network that includes other equipment could result in previously unidentified risks to patients, users or third parties;
     2. ii) the responsible organization should identify, analyse, evaluate and control these risks;

     NOTE 2

     IEC 80001-1 provides guidance for the responsible organization to address these risks.

     1. iii) subsequent changes to the IT network could introduce new risks and require additional analysis;
     2. iv) changes to the IT network include:

        — changes in the IT network configuration;

        — connection of additional items to the IT network;

        — disconnecting items from the IT network;

        — update of equipment connected to the IT network;

        — upgrade of equipment connected to the IT network.

7. g) The technical description should include a description regarding medical device problems that need to be diagnosed before the user can determine the correct remedial actions.
8. h) The technical description may be identified with symbol ISO 7000-1640.

Check conformity by inspection of the technical description.

6.6.5 Requirements for e-documentation

1. a) If the manufacturer has a website, the instructions for use of a medical device or accessory should be available on that website.
2. b) If the instructions for use are available on a website, the label of a medical device or accessory may include:
   • 1) a two-dimensional code (e.g. QR Code) in accordance with ISO 22742:2010; or
   • 2) a web address (uniform resource locator or URL).
3. c) Unless the applicable policy does not permit e-documentation, accompanying information may be provided by e-documentation.
4. d) If some or all of the accompanying information is provided as e-documentation, the manufacturer shall determine whether information also needs to be provided by other means such as printed material or as markings on the medical device or accessory.
   EXAMPLE

   Information to cover emergency operation.

   NOTE 1

   The usability engineering process is a method for developing the risk control measures for hazards and hazardous situations related to use.

5. e) If some or all of the accompanying information is provided as e-documentation, the manufacturer shall determine whether access to some information should be restricted to a specific user group.

   NOTE 2

   The risk management process is a method for developing the risk control measures for hazards and hazardous situations related to access of accompanying information by someone other than the intended user group.

6. f) Where accompanying information is provided on a medium other than printed material, the manufacturer shall ensure the user has information on how to:
   • 1) view the accompanying information;
   • 2) access the correct version of the accompanying information;
   • 3) obtain a printed version of the accompanying information.

Check conformity by inspection of the e-documentation.

7.1 Importer

1. a) Where the applicable policy requires the importer to be identified, the name or trade name and full address of the importer to which the responsible organization can refer in accordance with the applicable policy shall be included:
   • 1) on the label; or
   • 2) in the accompanying documentation.
2. b) Symbol ISO 7000-3725 or symbol 5.1.8 from ISO 15223-1:2021 may be used to identify the importer.
3. c) The address of the importer may be applied by someone other than the manufacturer.
   EXAMPLE

   A label applied by the importer and not the manufacturer.

   • 1) An additional label shall not obscure any information on the label provided by the manufacturer.
4. d) In locales where the importer is required to be registered, the address used shall be the same as the registered address.

Check conformity by inspection of the label or accompanying documentation, as applicable.

7.2 Distributor

1. a) Where the applicable policy requires the distributor to be identified, the label of a medical device or accessory shall include the name or trade name and full address of the distributor to which the responsible organization can refer.
   • 1) Symbol ISO 7000-3724 or symbol 5.1.9 from ISO 15223-1:2021 may be used to identify the distributor.
   • 2) The address of the distributor may be applied by someone other than the manufacturer.
     EXAMPLE

     A label applied by the distributor and not the manufacturer.

     1. i) An additional label shall not obscure any information on the label provided by the manufacturer.
2. b) In locales where this organization is required to be registered, the address used shall be the same as the registered address.

Check conformity by inspection of the label.

7.3 Repackaging

1. a) Where the applicable policy requires the distributor to be identified, the label of a medical device or accessory shall include the name or trade name and full address of the organization, other than the manufacturer, who has modified the original medical device or accessory packaging.
   • 1) Symbol ISO 7000-3727 or symbol 5.7.9 from ISO 15223-1:2021 may be used to identify this organization.
   • 2) The indication of repackaging and the address of this organization shall be applied by someone other than the manufacturer.
     1. i) An additional label shall not obscure any information on the label provided by the manufacturer.
2. b) Where necessary, the address used shall be the same as the registered address.

   NOTE

   This can be required by the authority having jurisdiction.

Check conformity by inspection of the label.

7.4 Translation

1. a) Where the applicable policy requires a translator outside the control of the manufacturer to be identified, the label of a medical device or accessory shall include the name or trade name and full address of the organization, other than the manufacturer, who is responsible for translated label or IFU of the original medical device or accessory.
   • 1) Symbol ISO 7000-3728 or symbolISO 15223-1:2021 may be used to identify this organization.
   • 2) The indication of translation outside the control of the manufacturer and address of this organization shall be applied by someone other than the manufacturer.
     1. i) An additional label shall not obscure any information on the label provided by the manufacturer.
2. b) In locales where this organization is required to be registered, the address used shall be the same as the registered address.

Check conformity by inspection of the label.

7.5 Regulatory identification

1. a) Where the applicable policy requires regulatory identification, the label of a medical device or accessory shall include, as applicable:
   • 1) regulatory reference information;
   • 2) conformity graphics;
   • 3) regulatory classification graphics.

     NOTE

     Such conformity graphics and regulatory classification graphics are not considered to be symbols.

2. b) Unless the applicable policy does not permit it, this information may be applied by someone other than manufacturer.
3. c) An additional label shall not obscure any information on the label provided by the manufacturer.

Check conformity by inspection of the label.

A.1 General guidance

This annex provides rationale for some requirements of this document and is intended for those who are familiar with the subject of this document but who have not participated in its development. An understanding of the rationales underlying these requirements is considered essential for their proper application. Furthermore, as clinical practice and technology change, it is believed that a rationale will facilitate any revision of this document necessitated by those developments.

A.2.1 Clause 1: Scope

The aim of this document is to serve as a source of the common, generally applicable requirements, whilst allowing each specific product standard or group standard to focus on the unique requirements for a specific medical device or group of medical devices. This document is intended to act as a means to support opportunities where harmonization efforts could be enhanced through its application.

Although combination products (a medical device with either a drug or biologic) are not explicitly excluded from the scope of this document, they are not explicitly treated. This is because there is not international harmonization of requirements for combination products.

A.2.2 3.7: Clearly legible

Vision or visual acuity can be tested by reading a Snellen eye chart at a distance of 6 m. Near vision can be tested using a Jaeger test card. By examining a large number of people, researchers have decided what a “normal” human being should be able to see at various distances. That is the description of normal vision.

A.2.3 3.11: Expected lifetime

It is up to the manufacturer to define the expected lifetime of their medical device. Since the risk management process requires the manufacturer to verify the effectiveness of all risk control measures, the manufacturer needs to assess the effectiveness of risk control measures for the entire expected lifetime (or there could be an unacceptable risk).

Further many authorities having jurisdiction have all sorts of activities that manufacturers are required to perform during the lifetime of their medical device. Manufacturers are required to continue to perform post-production surveillance and ensure that their medical device remains safe (e.g. by providing security updates during that expected lifetime). Typically, software manufacturers express the expected lifetime in relative terms. For example, at one point Microsoft supported Windows 7 and Windows 10, but had ceased supporting Windows XP. Software manufacturers tend to support one or 2 major releases and continue to send service updates and patches during that expected lifetime, but not longer.

A.2.4 6.1.3: Identification of the medical device or accessory

The identification schemes used by manufacturers can be very simple or can be complicated. This document uses a hierarchal structure of terms to cover the possibilities. That hierarchy is represented in the following example:

Not all types of identifiers are required for all medical devices.

A.2.5 6.1.5: Consult instructions for use

During the risk management process of a medical device or accessory, if the manufacturer determines that reading information within the instructions for use is a mandatory action necessary to control a specific risk to an acceptable level, then the safety sign ISO 7010-M002 notifies the user of that need. In other words, if the means for a user to avoid a specific and unacceptable risk is only reading (and understanding) the instructions for use, then the safety sign is required. If the user does not read (and understand) those instructions for use, the risk control is ineffective and there is an unacceptable risk.

The safety sign ISO 7010-M002 should not be used for indicating that it is a mandatory action to read the IFU for the disclosure of residual risk.

A.2.6 6.5.2: Packaging for the lay user a) 2)

The requirements in this subclause are in addition to the requirements in 6.5.1 for the packaging of all medical devices or accessories. Some medical devices or accessories come in sizes where selecting the correct size is important for the safe and effective use of the medical device or accessory. Examples include sphygmomanometer cuffs and crutches. The lay user needs this information on the sales packaging to ensure that they can select the appropriate medical device or accessory prior to purchasing.

A.2.7 6.6: Requirements for information in the instructions for use and technical description

The purpose of the IFU and technical description is to promote the safe and effective use of the medical device or accessory during its shelf-life or expected lifetime.

A.2.8 6.6.4: Requirements for technical description c) 8)

To collect meaningful data from multiple medical devices, the time stamps associated with the data need to be synchronized. To accomplish this, medical devices with an electronic interface need a method to have their internal time clocks synchronized to the local time. This disclosure provides the responsible organization with the information to accomplish this task.

A.2.9 Annex B: Example test method for assessing clearly legible requirements c)

When evaluating the observer’s visual acuity, it is not necessary to have the observer tested by an eye physician. Confirming that the observer has an appropriate visual acuity can be performed by anyone just prior to the evaluation by utilizing a Snellen chart for a distance check or a Jaeger test card for a normal reading distance check. These charts are readily, commercially available and should be thought of as test equipment for this test.

The Jaeger test card is used for determining near vision. N6 corresponds to reading at a distance of 0,87 m from the face.

If a recommended minimum font size is to be considered, then a readable font size is a function of reading distance and the resulting visual angle of the marking image presented to the retina of the eye. Calculations of visual angle in minutes of arc are found in ANSI/AAMI HE-75:2009^[23^], 6.2.2.6.5, Table 6.2. Using a minimal acceptable visual angle of 12 minutes of arc, a font size of 9 would be recommended for a reading distance of one meter and a font size of 6 for a typical reading distance of 0,7 m.

Annex B Example test method for assessing clearly legible requirements

The test method in this annex provides one means of demonstrating conformity to the clearly legible requirements of 6.3. Other means are possible.

Check conformity for clearly legible with the following test:

1. a) The medical device or its part is positioned so that the viewpoint is the intended position of the user.
2. b) If the intended position of the user is not specified and the position is not obvious, the viewpoint is at any point within the base of a cone subtended by an angle of 30± to the axis normal to the centre of the plane of the marking and at a distance of (1 ± 0,1) m or for medical devices intended to be held in the hand, at a distance (0,4 ± 0,1) m. The ambient illumination is the least favourable illumination level in the range of 100 lx to 1 500 lx.
3. c) The observer has a visual acuity, corrected if necessary, of:

   NOTE

   There is guidance or rationale for this list item in A.2.9.

   • 1) 0 on the log Minimum Angle of Resolution (log MAR) scale or 6/6 (20/20); or
   • 2) is able to read N6 of the Jaeger test card;
   as appropriate, in normal room lighting conditions, (500 ± 250) lx.
4. d) The observer correctly reads the label or marking from the viewpoint. If the observer is in doubt, repeat with 3 additional observers. If all 3 additional observers confirm the legibility, consider the test as passing.

Annex C Example test method for assessing durability

The test method in this annex provides one means of demonstrating conformity to the durability requirements of 6.4. Other means are possible.

Check conformity for durability by inspection and with the following test:

1. a) For medical devices or accessories that are not single use, perform the number of processing cycles determined by the expected lifetime in accordance with the methods indicated in the instructions for use.
2. b) Rub the markings on the medical device or accessory by hand, without undue pressure, first for 15 s with a cloth rag soaked with distilled water, then for 15 s with a cloth rag soaked with ethanol 96 % and then for 15 s with a cloth rag soaked with isopropyl alcohol.
3. c) Confirm that removable markings can only be removed:
   • 1) with an extra-corporeal object that can be used to secure or release a fastener; or
   • 2) by appreciable force.
4. d) Confirm that the markings remain clearly legible.

Annex D Reference to the IMDRF essential principles and labelling guidance

This document has been prepared to support the essential principles and labelling requirements of information supplied by the manufacturer as part of a medical device according to the International Medical Device Regulators Forum (IMDRF). This document is intended to be acceptable for conformity assessment purposes.

Conformity with this document provides one means of demonstrating conformity with the specific essential principles of IMDRF/GRRP WG/N47:2024^[24^] and labelling principles IMDRF/GRRP WG/N52:2024^[25^]. Other means are possible. Table D.1 maps the clauses and subclauses of this document with the essential principles of IMDRF/GRRP WG/N47:2024. Table D.2 maps the clauses and subclauses of this document with the labelling principles of IMDRF/GRRP WG/N52:2024.

Annex E Alphabetized index of defined terms

Bibliography