The primary purpose of labelling is to identify the medical device and its manufacturer, and communicate safety and performance related information to the user, professional or lay, or other person, as appropriate. Such information may appear on the device itself, on packaging or as instructions for use.

• Label: written, printed, or graphic information either appearing on the medical device itself, or on the packaging of each unit, or on the packaging of multiple devices.
• Labelling: the label, instructions for use, and any other information that is related to identification, technical description, intended purpose and proper use of the medical device, but excluding shipping documents.
• Primary Packaging: contains and protects the article so it is normally in contact with it. Can be sterile or no sterile EX: sachet, plastic box, peel-open pack
• Secondary Packaging: A pack component with no product contact but may add protection to that provided by the immediate pack. EX: cardboard box, rigid wrapping.

Guideline

IMDRF (International Medical Device Regulators Forum): IMDRF/GRRP WG/N52 FINAL:2019: Principles of Labeling for Medical Devices and IVD Medical Devices

​https://www.imdrf.org/sites/default/files/docs/imdrf/final/technical/imdrf-tech-190321-pl-md-ivd.pdf

UNIQUE DEVICE IDENTIFICATION – UDI

Definition of UDI

A series of numeric or alphanumeric characters that is created through internationally accepted device identification and coding standards and that allows unambiguous identification of specific devices on the market.
UDI is a unique numeric or alphanumeric code, displayed in both human readable (plain text) and machine readable AIDC (Automatic identification and data capture) form, that consists of two parts: the device identifier (DI) and the production identifier(s) (PI)

• DI = Device Identifier: Mandatory, fixed portion of a UDI that identifies the specific version or model of a device and the labeler of that device. It is also the identifier used to access the UDI Database.
• PI = Production Identifiers: a variable code related to production data of the device, such as lot/batch number, expiry date, manufacturing date, etc.

Objective of UDI

• Establish a system to adequately identify devices through distribution and use
• Facilitate the rapid and accurate identification of a device
• Enable access to important information concerning the device
• Allow more accurate reporting, reviewing, and analyzing of adverse event reports.
• Provide a standard and clear way to document device use in electronic health records, clinical information systems, claims, data sources and registers.
• Enable more efficiently managed device recalls

Example

UDI barcode combines the Device Identifier (DI) which would be a static portion to the barcode and then the Production Identifier (PI), which would be a dynamic portion to the barcode, including Application Identifiers such as Manufacturing date (AI-11), Serial (AI-21), Lot Number (AI-10) and Expiration Dates (AI-17).

Data delimiter means a defined character or set of characters that identifies specific data elements within an encoded data string. The data delimiters are key to UDI comprehensibility and utility. The data delimiters indicate the DI value or the PI values that follow each data delimiter within the UDI.

The final human readable string for this example: (01)51022222233336(11)141231(17)150707(10)A213B1(21)1234

UDI regulation

UDI’s are issued by an accredited UDI issuing agency (FDA or EU)
Conform to each of the following international standards:
ISO/IEC 15459: Information technology -- Automatic identification and data capture techniques -- Unique identification. the different parts are confirmed in 2020.

• Part 2: 2015: Registration procedures
• Part 4: 2014: Individual products and product packages
• Part 6: 2014: Groupings

Use only characters and numbers from the invariant character set of ISO/IEC 646 (information technology: 7-bit coded character set for information interchange)

UDI issuing entities

The Official Journal of the European Union (OJEU) of 7 June 2019, has announced the four UDI issuing agencies applicable for Medical Devices under the MDR and In-Vitro Diagnostic Medical Devices IVDR. These agencies will issue the unique codes necessary for UDI. This assignment will be valid for five years, after which designations will be reviewed by the European Commission and possibly renewed.

• IFA GmbH: Informationsstelle für Arzneispezialitäten (IFA GmbH is an information service provider for the pharmaceutical market, providing information services including economic, legal and logistic data for goods sold in pharmacies in Germany)

The other identified agencies are already active for US FDA UDI. They are:

• GS1: a not-for-profit organization that develops and maintains global standards for business communication. The best known of these standards is the barcode, a symbol printed on products that can be scanned electronically.
• Health Industry Business Communications Council (HIBCC): was established in 1983 as an industry-sponsored nonprofit council by major health care associations to develop a standard for data transfer using uniform bar code labelling. Over time, it has expanded its focus to include additional electronic data interchange standards.
• International Council for Commonality in Blood Banking Automation (ICCBBA): is an international not-for-profit non-governmental standards organization in official relations with the World Health Organization (WHO) and is responsible for management and development of the ISBT 128 Standard (a global standard for the identification, labelling, and information transfer of medical products of human origin, including blood).

GUDID

The Global Unique Device Identification Database (GUDID) is administered by the FDA and serves as a reference catalog for every device marketed in the US with an identifier. Under the UDI rule, the labeler of each medical device labeled with a unique device identifier (UDI) must submit information concerning that device to the GUDID, unless subject to an exception or alternative. The GUDID contains ONLY the device identifier (DI), which serves as the primary key to obtain device information in the database. The database is free access.

Guideline

IMDRF (International Medical Device Regulators Forum): UDI Guidance, December 2013

MEDICAL DEVICE NOMENCLATURE

A global Medical Devices nomenclature is required, to support faster regulatory process, easier selection, improved procurement and supply, increased trade and better asset management, in order to increase patient safety, better allocation of resources, post market surveillance and impact the access and availability of medical devices to support better health care delivery.
The European Medical Device Nomenclature (EMDN) will be the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database.
Founded on pre-established criteria and requirements and based on orientations provided by the Medical Device Coordination Group (MDCG), the European Commission decided in favour of the use of the ‘Classificazione Nazionale Dispositivi medici (CND)’ as the basis for the EMDN. To the extent possible, the Commission will map the EMDN to the Global Medical Device Nomenclature (GMDN).

EMDN / CND nomenclature

This nomenclature is characterized by its alphanumeric structure that is established in a multi-level hierarchical tree. It clusters medical devices in three main levels:
1 = Category
2 = Group
3 = Type (which if necessary, expands into several levels of detail)
Each MD is classified by an alphanumeric code consisting of a letter referring to the Category, a couple of numbers referring to the Group and a series of other couples of numbers referring to the Type (whose amount depends on the level of detail) up to a maximum of 7 levels.

GMDN: Global Medical Device Nomenclature

GMDN is a system of internationally agreed descriptors used to identify medical device products.
GMDN is managed by the GMDN Agency, a non-profit organization which reports to its Board of Trustees, that represents medical device regulators and industry.
Medical device experts from around the world (manufacturers, healthcare authorities and regulators) compiled the GMDN, based on the international standard ISO 15225. The work was mandated by the European Commission in order to provide the necessary tool to carry out the implementation of the Medical Devices Directive, including the European databank for medical devices (Eudamed)
The GMDN term is in the form of a 5-digit numeric GMDN Code cross-referenced to a specific Term Name and Definition, with which all specific medical devices having substantially similar generic features, can be identified. They are mentioned at the bottom of the definition in the technical sheet of the MD.

UMDNS: Universal Medical Device Nomenclature System

UMDNS is owned and copyrighted by ECRI Institute (an independent international nonprofit organization that researches approaches to improving patient care). Codes are free to be used by any stakeholder but do not contain the granularity required.
UMDNS contains 10,056 unique medical device concepts and definitions (preferred terms), along with an additional 23,004 entry terms to facilitate classifying of biomedical information. UMDNS contains explicit relationships among the 33,000+ terms, including hierarchical relationships and synonymous relations, as well as relationships among related devices.

UNSPSC: United Nations Standard Products and Services Code

UNSPSC a four-level hierarchy coded as an eight-digit number, with an optional fifth level adding two more digits. The UNSPSC was jointly developed by UNDP and is currently managed by GS1 US.

HS (Harmonized System)

The Harmonized Commodity Description and Coding System is an internationally standardized system of names and numbers to classify traded products. It came into effect in 1988 and has since been developed and maintained by the World Customs Organization (WCO), an independent intergovernmental organization based in Brussels, with over 200 member countries.

GRAPHICAL SYMBOLS FOR USE IN THE LABELLING OF MD AND IVD

Definition

According to ISO 14971: graphical representation appearing on the label and/or associated documentation of a medical device that communicates characteristic information without the need for the supplier or receiver of the information to have knowledge of the language of a particular nation or people. The symbol can be an abstract pictorial or a graphical representation, or one that uses familiar objects, including alphanumeric character. These symbols may be used on the medical device itself, on its packaging or in the associated documentation.

Standards

• ISO 15223-1: 2021: Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements
• identifies requirements for symbols used in medical device labelling that convey information on the safe and effective use of medical devices.
• It also lists symbols that satisfy the requirements of ISO 15223-1.
• is applicable to symbols used in a broad spectrum of medical devices, which are marketed globally and therefore need to meet different regulatory requirements.
• EN 15986:2011: Symbol for use in the labelling of medical devices. Requirements for labelling of medical devices containing phthalates
• ISO 7000:2019: Graphical symbols for use on equipment -- Registered symbols
• ISO 780:2015 (confirmed in 2021): Packaging — Distribution packaging — Graphical symbols for handling and storage of packages
• IEC TR 60878:2015: Graphical symbols for electrical equipment in medical practice