ISO 15223-1:2021 is an international standard that specifies symbols to be used with information supplied by manufacturers for medical devices. It provides a standardized set of symbols for clear, concise communication on medical device labels, packaging, and accompanying documentation.

This standard is crucial for several reasons:

• It establishes a universal language for medical device labeling, overcoming language barriers.
• It ensures consistent, globally understood labeling for medical devices.
• It helps manufacturers comply with regulatory requirements, including EU MDR and IVDR.
• It enhances user safety through clear information presentation.
• It reduces translation costs and potential labeling errors for manufacturers.

The standard includes several important features:

• An updated symbol set, including new symbols like the MD symbol for medical devices.
• An expanded scope that covers information supplied by manufacturers beyond physical labels.
• Harmonization with EU MDR and IVDR requirements.
• Symbols for various aspects such as sterilization, use limitations, storage conditions, and handling instructions.

This standard is intended for use by:

• Medical device manufacturers
• Regulatory professionals in the medical device industry
• Quality assurance teams
• Packaging and labeling designers
• Anyone involved in the production or regulation of medical devices

The symbols in this standard cover a wide range of information, including but not limited to:

• Storage and handling conditions
• Sterilization status and methods
• Manufacturing and expiration dates
• Warnings and precautions
• Device identification (e.g., catalogue numbers, model numbers)
• Instructions for use

ISO standards are typically reviewed every five years to ensure they remain relevant and up-to-date. The current version, ISO 15223-1:2021, is the fourth edition, replacing the previous 2016 version. However, updates can occur more frequently if significant changes in the industry necessitate it.

While ISO standards are voluntary, many regulatory bodies around the world recognize ISO 15223-1:2021 as a benchmark for medical device labeling. Compliance with this standard often facilitates regulatory approval processes and is considered a best practice in the industry.

mplementing the standard typically involves:

1. Reviewing the new requirements and assessing their impact on current labeling practices.
2. Updating label designs and internal documentation to incorporate the required symbols.
3. Training staff on the new requirements and symbol usage.
4. Integrating the new labeling into the quality management system.
5. Conducting internal audits to ensure compliance.
6. Potentially undergoing external audits or certifications.

ISO 15223-1:2021 is part of a broader ecosystem of medical device standards. It works in conjunction with other standards such as ISO 20417:2021 (Information to be supplied by the manufacturer) and various regulatory requirements like the EU MDR. Understanding its relationship with these other standards is crucial for comprehensive compliance in the medical device industry.

ISO 15223-1:2021 introduces several significant updates:

• Addition of 25 new symbols to the standard
• Expansion of the scope to cover "information supplied by the manufacturer" beyond just physical labels
• Updated definitions aligned with ISO 20417, ISO 14971, and ISO 13485
• Revised requirements for using symbols, including mandatory specification of appropriate symbol sizes
• Extended examples in Annex A for symbol usage and combined use of multiple symbols

The scope has been broadened from "medical device labels, labelling and information to be supplied" to "information to be supplied by the manufacturer." This expansion includes not only physical labels but also technical descriptions and instructions for use, reflecting a more comprehensive approach to medical device information.

While the exact details of all 25 new symbols are not provided, some notable additions include:

• Symbols to support the Universal Device Identification (UDI) system
• New symbols for the implantation ID card
• A "translation" symbol for use when translation is outsourced

The new version aligns more closely with current regulatory requirements, particularly:

• EU Medical Device Regulation (MDR) 2017/745
• In vitro Diagnostic Medical Devices Regulation (IVDR)
• It's harmonized with EU standards, potentially simplifying compliance for manufacturers

Yes, the standard now:

Requires manufacturers to specify the appropriate size of symbols (changed from "shall" to "must")
Provides more detailed guidance on the joint use of multiple symbols
Includes updated requirements for symbol presentation and use in tabular form

The standard now states that symbols listed in ISO 15223-1:2021 don't always need explanation in the instructions for use, unless:

• It could lead to higher risks from the device (to be determined through usability studies)
• The device is intended for lay users, in which case symbols must always be explained

The standard now presents symbol information in a more structured format, including:

• Reference number and graphic
• Symbol title
• Symbol description
• Requirements
• Notes
• Restriction of use
• ISO/IEC symbol number and registration date

Devices already in the field do not require immediate labeling updates. However, manufacturers of devices in production should examine the new standard for applicability and consider updating their labeling to align with the new requirements.

Labeling changes resulting from adopting ISO 15223-1:2021 are considered significant as per MDCG 2020-3 Guidance. This means that manufacturers may need to submit change notifications to their Notified Bodies when implementing these updates.