Medical Device Label Translation Everything You Need to Know

Medical device companies who wish to sell their products in their respective countries must adhere to the regulations provided by the country’s regulatory bodies for labeling medical devices.

Do you know? One-third of all medical errors are caused by poor labeling. Labeling and packaging issues are the leading causes of medication errors. Instructions on medical device labeling are things that should be understandable to the user who reads them without any medical knowledge.

The FDA’s Center for Devices and Radiological Health reports that one-third of the roughly 100,000 medical device event reports they receive each year are attributed to the device’s ‘usage error’.

What is Medical device labeling?

As per the FDA, the ‘display of written, printed, or graphic matter upon the immediate container of any article..’ is called a “label.” Any physician prescribing the device should be able to find the information on the label quickly, and any patient should be able to understand how to use their medical device at home. Failure of this will lead to severe complications, and sometimes, the improper usage of medical devices can even lead to death.

How important is the labeling of medical devices to manufacturers?

Medical device labeling is the most critical part of the medical device manufacturing process. Accurate labeling of medical devices with all the required information is vital to ensuring market access and the safe and proper use of medical devices by patients and caretakers of patients.

How does the failure of labeling and compliance damage the manufacturers?

Labeling is one of the most serious and heavily scrutinized parts of the product authorization process. The cost of failing to correctly label a medical device or failing to include all the appropriate information can be significant damage to manufacturers.

As guided by the FDA, improper use related to incorrect or insufficient labeling can lead to product recalls or export bans, which bring with them financial penalties and potential reputational damage. The omission of key information can cause costly delays to market entry.

How to get the labeling review done?

Manufacturers must list their medical devices with the FDA as per the Medical Device Listing-21CFR Part 807. The FDA has given specific guidelines for Medical device labeling for manufacturers and medical device labeling reviewers on how to ensure the label for a medical device for patient use follows the guidelines specified by regulations. Every country has its own rules to follow while following the global regulations for marketing in different countries.

For Europe, UDI, and EUDAMED to comply with EU MDR medical device labeling requirements, there are certain guidelines shared by EU regulatory authorities for Medical devices and EU MDR Compliance.

Health Canada’s guidelines for Medical device labeling specify how a device should be labeled according to its regulations when it is released into the Canadian Market.

Similarly, the Therapeutic Goods Administration, Australia has also specified their Medical Device labeling guidelines for Australia for the products that are being marketed in their country.

How can Cigniti help you in reviewing your medical device labels?

We have a dedicated team that has an in-depth understanding of multiple regulatory authorities and their guidelines, such as the US FDA, TGA, EMA, Health Canada, etc.

With the experts in dealing with regulatory requirements for medical device labeling, we will thoroughly review your labels for the latest mandatory regulatory requirements, specifications, and symbols to identify any flaws or deviations from guidelines for any product being marketed in their respective countries.

We will suggest the changes required for the label and any new updates that must be added to the existing label for any new regulatory update (E.g., Implementation of EU MDR Label Changes).

We will notify the customer of any new or upcoming changes to any medical device label that has already been reviewed.

Need help? Consult our team of dedicated Medical Devices Testing professionals to learn more about the importance of labeling in medical devices.