Labeling Medical Devices: A Guide

Labeling medical devices is complex and highly regulated. This guide provides information on printing and labeling tools that will help you label properly and stay within compliance.

A note about compliance: This guide does not cover specifics on compliance. If you are looking for information on the laws and guidelines for medical device labeling compliance, please refer to:

• In the United States: FDA governs Unique Device Identification system (UDI)
• In the European Union: European Union is implementing Medical Device Regulations (MDR)

In addition, if you are looking for information on pharmaceutical labeling, please read Pharmaceutical Label Compliance: What you need to know.

Standardization for Labeling Medical Devices

Labeling and application regulations ensure that labels are applied property and will withstand the rigors of the environments they are exposed to. Label reliability is vital for supply chain efficiency and patient safety.

Medical Device Labels are used in many ways, including:

• General Surgical Supplies
• Patient Monitoring
• Hospital Supplies
• Urology
• Orthopedic Soft Goods
• Respiratory Care
• Wound Care
• Sterilized Supplies
• Equipment
• Blood Bags, Specimens

No matter how they are used, they must:

• Be of high-quality print
• Be smudge resistant
• Withstand sterilization
• Hold up under chemicals
• Endure under extreme temperatures

In order to achieve the correct durability and dependability, the type of printing process that is used is called thermal transfer.

For this type of printing is really important that you use the right combination of printer ribbon and label type. This depends on what the label is being applied to.

The type of label material that is used is typically one of the following:

• Polyester
• Polypropylene / BOPP
• Synthetic Paper
• Coated Paper

The type of ribbon can be:

There are many combinations and finding the right one can be tricky. Using the wrong combination may not provide the proper label solution and may also cost you time and money.

The best way to avoid this is to have a label expert help you determine what is is best for your unique situation.

At PaladinID, we offer you the right products and have the experience and expertise to put together a labeling solution for any application that will exceed your expectations.  Give us a chance to prove it.