The Importance of Reviewing Medical Device Labels

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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 devices or labelling 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 ‘usage error’ of the Device.

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 who is prescribing the device should be able to find the information on the label quickly, and any patient should be able to understand the information on how to use their medical device at home. Failure of this will lead to serious 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 important and 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 for 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, while 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 certain guidelines for Medical device labeling for manufacturers and medical device labeling reviewers on how to make sure the label for a medical device for patient use follows the guidelines as specified by regulations. Every country has its own regulations to follow while following the global regulations for marketing in different countries.

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

Guidelines for Medical device labeling for Health Canada specify how the device should be labeled as per their 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 in-depth understanding of multiple regulatory authorities and their guidelines, such as 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 that is being marketed in their respective countries.

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

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

Need help? Consult our team of dedicated Medical Devices Testing professionals to learn more about the importance of reviewing medical device labels.


  • Anusha Chowdary

    Anusha Chowdary is a Senior Business Analyst and Domain expert for Healthcare with 10 years of experience in working with Healthcare and Healthcare IT. She is an experienced professional and subject matter expert in handling Drug safety applications. Her expertise includes thorough knowledge of health care and pharmaceutical regulations, with an educational background in Pharmacy.

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