Medical Devices: Understanding Labelling Symbols & Manufacturer Standards

In this article, we’ll examine the importance of clear and compliant labelling for medical devices and explore key symbols, regulatory frameworks, and global Standards for manufacturers.

If you’re an industry professional involved in compliance, design, or distribution, this article is for you!

Why Medical Device Labelling Matters

Medicine is a field which allows no room for errors. Medical device labelling requires clear and accurate information outlining the proper device usage. Medical device labelling regulations ​protect patient safety and provide trust throughout the industry that the correct device is being used in the right way.

Medical device labelling Standards provide the following benefits:

• They assist productivity for doctors, nurses and technicians because compliant labelling saves any wasted time identifying medical devices.
• It improves global trade because the labelling is consistent from country to country.
• Regulatory approval is easier to obtain in a specific country due to clear and direct labelling practices.
• Compliant labelling reduces risk to manufacturers.
• Medical device Standards always reflect the current best practices for labelling worldwide.
• Standardisation of labelling, including the use of internationally-recognised symbols, helps to overcome language barriers and increase comprehension.

Overview of Medical Device Labelling Regulations

What are the core regulatory frameworks governing medical device labelling around the world? Labelling regulations vary from country to country, of course. Some of these frameworks are:

• The EU MDR (European Union Medical Devices Registration) is a set of medical device compliance Standards that oversee the sales, distribution and production of medical devices throughout Europe. It was introduced to stamp out defective medical devices in Europe and ensure the effectiveness and safety of all devices going forward.
• In the USA, the FDA (United States Food and Drug Administration) regulates the sale of medical device products in the U.S. and monitors the safety of all regulated medical products. Before a medical device can be legally sold in the U.S., the seller must seek approval from the FDA.
• In Australia, the TGA (Therapeutic Goods Administration) evaluates, assesses and monitors all medical devices across Australia. It provides its guidance through the ARGMD (Australian Regulatory Guidelines for Medical Devices).
• ISO 15223-1 is the international Standard that specifies the symbols used to express information supplied for a medical device. These symbols can be used on the medical device itself, on its packaging or in the accompanying information.

These medical device labelling regulations​ affect device classification, UDI (Unique Device Identification), and language requirements.

Common Symbols in Medical Device Labelling

Here are some of the key symbols for medical device labelling that are used internationally under ISO 15223-1:

Common Symbols
Symbol	Meaning
	Manufacturer: This Medical Device Symbol must be displayed alongside the name and address of the manufacturer, positioned next to the symbol.
	Use-by date: This Medical Device Symbol shall be accompanied by a date to indicate that the medical device should not be used after the end of the year, month or day shown.
	Sterile: Indicates a medical device that has been subjected to a sterilisation process.
	Do not re-use: Indicates a medical device that is intended for one single use only.

Understanding Manufacturer Responsibilities

While exact regulations for medical device Standards and their labelling are not the same in each country, this section outlines many common labelling responsibilities for a manufacturer.

• Unique Device Identifiers (UDIs) allow clear and unambiguous identification of medical devices and assist with traceability. In Australia, there is a UDI for each model of medical device, and it consists of a combination of numbers, letters and symbols. There is a UDI-Device Identifier (UDI-DI) that indicates the model of the medical device. There is also a UDI-Production Identifier (UDI-PI), which provides the production-specific information, such as lot or batch number.
• Instructions must include the intended use, handling, storage, and recommended user of the device.
• Risk warnings, precautions or restrictions for safe use must be included on the labelling.
• The expiration date must be included, if applicable.

Global Standards for Medical Device Labelling

Medical device labelling Standards vary across major regions such as Europe, Australia, Canada and the USA. The International Standard for medical device labelling is ISO 15223 “Medical devices — Symbols to be used with information to be supplied by the manufacturer” and contains the globally-accepted best practices for labelling. To make the “minefield” of country-specific regulations easier to navigate for manufacturers, there have been significant international harmonisation and convergence efforts by the IMDRF (International Medical Device Regulators Forum), which replaces the earlier Global Harmonisation Task Force.

The IMDRF is composed of regulatory agencies from the different regions of the world and has the stated purpose to “strategically accelerate international medical device regulatory convergence to promote an efficient and effective regulatory model for medical devices that is responsive to emerging challenges while protecting and maximising public health and safety”.

Let’s wish them luck!

How to Maintain Compliance with Labelling Standards

Some proactive tips for staying compliant with medical device compliance Standards concerning labelling are:

• Following the label validation process for each country to which the medical device will be exported.
• Efficient document control for the approvals from each country’s regulators.
• Using audit-ready templates to easily stay on top of your compliance process.
• Keeping up-to-date with regulation changes.

Digital Labelling & eIFU (Electronic Instructions for Use)

What are the emerging trends in digital labelling? Digital labelling is being rapidly embraced throughout the industry because it improves the accessibility of information for regulators and users. The digital label can be easily accessed through a tablet or smartphone in the user’s language of choice. The instructions must comply with the guidelines for manufacturers about supplying eIFU (Electronic Instructions for Use).

Frequently Asked Questions

What is the purpose of medical device labelling symbols?


These symbols help ensure that the crucial information about a medical device is clearly relayed across different languages and ethnic groups.

Are ISO symbols mandatory for all markets?


While ISO symbols for medical devices show the “best practice” for these symbols around the world, it’s possible that an individual country might make up its own symbols. This is because ISO symbols are not mandatory. Fortunately, most countries do adhere to the ISO symbols!

What information must be on a medical device label?


This can vary from country to country. In Australia, the TGA (Therapeutic Goods Administration) requires the manufacturer's information, intended use of the device, its Unique Device Identifier (USD), serial number, warnings, restrictions, instructions for handling, storage or use of the device, expiration date, etc.

If applicable, the information can include the word “STERILE”, whether it is for single use, custom-made, “for export only”, or any other relevant information.

What happens if a label is non-compliant?

If the medical device labelling doesn’t comply with a country’s regulations, the device won’t be approved until you fix it. Non-compliance can also leave you open to fines and legal action.