ISO 20417:2021
Medical devices — Information to be supplied by the manufacturer
NOTE 1 There is guidance or rationale for this Clause contained in Clause A.2.
This document specifies the requirements for information supplied by the manufacturer for a medical device or by the manufacturer for 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.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General considerations
5 Information elements to be established
5.1 Units of measurement
5.2 Graphical information
5.3 Language and country identifiers
5.3.1 Language identifiers
5.3.2 Country identifiers
5.4 Dates
5.5 Full address
5.6 Commercial product name
5.7 Model number
5.8 Catalogue number
5.9 Production controls
5.10 Unique device identifier
5.11 Types of use/reuse
5.12 Sterile
6 Requirements for accompanying information
6.1 Requirements for information to be supplied on the label
6.1.1 Minimum requirements for the label
6.1.2 Identification of the manufacturer
6.1.3 Identification of the medical device or accessory
6.1.4 Other label requirements
6.1.5 Consult instructions for use
6.1.6 Safety signs
6.2 Identification requirements for detachable components of a medical device or accessory
6.3 Legibility of the label
6.4 Durability of markings
6.5 Information to be provided on the packaging
6.5.1 General information
6.5.2 Packaging for the lay user
6.5.3 Special conditions indicated on the packaging
6.6 Requirements for information in the instructions for use and technical description
6.6.1 General
6.6.2 Requirements for instructions for use
6.6.3 Additional requirements for the instructions for use for a lay user
6.6.4 Requirements for technical description
6.6.5 Requirements for e-documentation
7 Other information that is required to be supplied with the medical device or accessory
7.1 Importer
7.2 Distributor
7.3 Repackaging
7.4 Translation
7.5 Regulatory identification
Annex A (informative) Particular guidance and rationale
Annex B (informative) Example test method for assessing clearly legible requirements
Annex C (informative) Example test method for assessing durability
Annex D (informative) Cross reference between the document and the requirements considered
Annex E (informative) Reference to the IMDRF essential principles and labelling guidances
Annex F (informative) Reference to the essential principles
Annex G (informative) Reference to the general safety and performance requirements for medical devices
Annex H (informative) Reference to the general safety and performance requirements for IVD medical devices
Annex I (informative) Terminology — Alphabetized index of defined terms
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General considerations
5 Information elements to be established
5.1 Units of measurement
5.2 Graphical information
5.3 Language and country identifiers
5.3.1 Language identifiers
5.3.2 Country identifiers
5.4 Dates
5.5 Full address
5.6 Commercial product name
5.7 Model number
5.8 Catalogue number
5.9 Production controls
5.10 Unique device identifier
5.11 Types of use/reuse
5.12 Sterile
6 Requirements for accompanying information
6.1 Requirements for information to be supplied on the label
6.1.1 Minimum requirements for the label
6.1.2 Identification of the manufacturer
6.1.3 Identification of the medical device or accessory
6.1.4 Other label requirements
6.1.5 Consult instructions for use
6.1.6 Safety signs
6.2 Identification requirements for detachable components of a medical device or accessory
6.3 Legibility of the label
6.4 Durability of markings
6.5 Information to be provided on the packaging
6.5.1 General information
6.5.2 Packaging for the lay user
6.5.3 Special conditions indicated on the packaging
6.6 Requirements for information in the instructions for use and technical description
6.6.1 General
6.6.2 Requirements for instructions for use
6.6.3 Additional requirements for the instructions for use for a lay user
6.6.4 Requirements for technical description
6.6.5 Requirements for e-documentation
7 Other information that is required to be supplied with the medical device or accessory
7.1 Importer
7.2 Distributor
7.3 Repackaging
7.4 Translation
7.5 Regulatory identification
Annex A (informative) Particular guidance and rationale
Annex B (informative) Example test method for assessing clearly legible requirements
Annex C (informative) Example test method for assessing durability
Annex D (informative) Cross reference between the document and the requirements considered
Annex E (informative) Reference to the IMDRF essential principles and labelling guidances
Annex F (informative) Reference to the essential principles
Annex G (informative) Reference to the general safety and performance requirements for medical devices
Annex H (informative) Reference to the general safety and performance requirements for IVD medical devices
Annex I (informative) Terminology — Alphabetized index of defined terms
Bibliography